BPC-157 · Staresinic et al., J Orthop Res (2003)
ANIMAL2003In vivo (rat) with in-vitro tendocyte assay
Staresinic M, Sebecic B, Patrlj L, et al. · Journal of Orthopaedic Research
- Population
- Rat Achilles-tendon transection; cultured tendocytes
- Objective
- To test whether BPC-157 affected transected Achilles-tendon healing in rats and tendocyte growth in culture.
- Endpoint investigated
- Tendon healing and tendocyte growth in a rodent model
In a rat Achilles-transection model, BPC-157 was reported to accelerate tendon healing relative to controls, with a parallel in-vitro observation of tendocyte growth. The work is a primary source for the preclinical tendon literature on this compound.
Limitations. Rodent surgical model; findings do not establish human tendon outcomes. Originates in the laboratory group that accounts for much of the BPC-157 literature.
DOI 10.1016/S0736-0266(03)00110-4 · Staresinic et al., J Orthop Res (2003) · Reviewed 12 September 2026
BPC-157 · Chang et al., Molecules (2011)
IN VITRO2011In vitro (tendon fibroblasts)
Chang CH, Tsai WC, Lin MS, Hsu YH, Pang JH · Molecules
- Population
- Cultured tendon fibroblasts
- Objective
- To examine growth-hormone receptor expression in tendon fibroblasts exposed to BPC-157.
- Endpoint investigated
- Growth-hormone receptor expression in cultured cells
Cultured tendon fibroblasts exposed to BPC-157 were reported to increase growth-hormone receptor expression. The paper is mechanistic and cellular, not a clinical outcome study.
Limitations. Cell-culture system only. Receptor expression in vitro is not a clinical endpoint and is not a basis for human-use claims.
DOI 10.3390/molecules16119672 · Chang et al., Molecules (2011) · Reviewed 12 September 2026
BPC-157 · Sikiric et al., Curr Pharm Des (2020)
REVIEW2020Narrative review
Sikiric P, Hahm KB, Blagaic AB, et al. · Current Pharmaceutical Design
- Objective
- To summarise the originating group's preclinical BPC-157 literature on cytoprotection and vascular effects.
- Endpoint investigated
- Preclinical cytoprotection and related mechanistic claims
A review from the principal BPC-157 laboratory grouping, collecting animal and mechanistic papers. It is a map of that corpus, not independent confirmation of it.
Limitations. Narrative, not systematic. Dominated by one research network. Does not add new human interventional data.
DOI 10.2174/1381612825666191116102917 · Sikiric et al., Curr Pharm Des (2020) · Reviewed 12 September 2026
BPC-157 · Lee and Padgett, Altern Ther Health Med (2021)
HUMAN DATA2021Retrospective case series
Lee E, Padgett B · Alternative Therapies in Health and Medicine
- Population
- Adults treated for mixed knee complaints in a clinical practice
- Sample
- n = 16 (12 BPC-157 alone; 4 combined with TB-500)
- Objective
- To describe pain scores after intra-articular BPC-157 in a small, uncontrolled series.
- Endpoint investigated
- Patient-reported knee pain in an uncontrolled series
A retrospective series of sixteen people given intra-articular BPC-157 for mixed knee diagnoses, some also given TB-500. Subsequent sports-medicine reviews cite it as the main human orthopaedic report — and as methodologically inadequate for inference.
Limitations. No control arm, mixed diagnoses, mixed co-interventions, small n, retrospective. Cannot attribute outcomes to the compound. Not a trial.
Lee and Padgett, Altern Ther Health Med (2021) · Reviewed 12 September 2026
BPC-157 · Mayfield et al., Am J Sports Med (2026)
REVIEW2026Narrative review
Mayfield CK, Bolia IK, Feingold CL, Lin EH, Liu JN, Hatch GFR, Gamradt SC, Weber AE · The American Journal of Sports Medicine
- Objective
- To summarise published evidence on injectable peptides marketed for orthopaedic and sports indications.
- Endpoint investigated
- Whether published studies support clinical use in orthopaedics
Sports-medicine review covering BPC-157 among other peptides. It reports that tendon and muscle findings are largely unvalidated in humans, and treats the Lee–Padgett series as limited by design.
Limitations. Narrative review of an uneven literature. Not a systematic evidence grade.
DOI 10.1177/03635465251357593 · Mayfield et al., Am J Sports Med (2026) · Reviewed 12 September 2026
BPC-157 · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026Regulatory listing
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position and stated characterisation concerns.
- Endpoint investigated
- Compounding classification, not efficacy
BPC-157 appears on FDA's table of bulk substances nominated for compounding and withdrawn by the nominator. Published concerns include immunogenicity risk, peptide-related impurities, and complexity of API characterisation. Placement is a regulatory classification.
Limitations. A withdrawn nomination is not a safety assessment of any particular material, and it is not a clinical evidence review.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
BPC-157 · WADA 2026 Prohibited List
REGULATORY2026Anti-doping listing
World Anti-Doping Agency · WADA Prohibited List
- Objective
- To record the substance's position on the 2026 Prohibited List.
- Endpoint investigated
- Sporting prohibition status
Named in Class S0 (Non-Approved Substances). Prohibited at all times; Specified Substance. This is an anti-doping classification, not a finding about laboratory research use.
Limitations. WADA listing is not a determination of chemical identity or of any research endpoint.
WADA 2026 Prohibited List · Reviewed 12 September 2026
TB-500 · Malinda et al., J Invest Dermatol (1999)
ANIMAL1999In vivo (animal wound models) — parent molecule
Malinda KM, Sidhu GS, Mani H, et al. · Journal of Investigative Dermatology
- Population
- Animal full-thickness wound models
- Objective
- To test whether full-length thymosin β4 affected wound closure in animals.
- Endpoint investigated
- Wound closure with full-length Tβ4, not TB-500
Full-length thymosin β4 was reported to accelerate wound healing in animal models. The paper is listed here because the commercial name TB-500 is routinely treated as interchangeable with Tβ4 — which it is not.
Limitations. This is evidence about thymosin β4 (43 residues), not about the acetylated LKKTETQ heptapeptide sold as TB-500. Do not read it as a TB-500 study.
DOI 10.1046/j.1523-1747.1999.00696.x · Malinda et al., J Invest Dermatol (1999) — Full-length thymosin β4, not the TB-500 fragment. · Reviewed 12 September 2026
TB-500 · Mayfield et al., Am J Sports Med (2026)
REVIEW2026Narrative review
Mayfield CK, Bolia IK, Feingold CL, Lin EH, Liu JN, Hatch GFR, Gamradt SC, Weber AE · The American Journal of Sports Medicine
- Objective
- To separate published Tβ4/TB-500 claims from orthopaedic evidence.
- Endpoint investigated
- Human orthopaedic evidence for Tβ4 and TB-500
The review states that Tβ4 and its derivative TB-500 promoted angiogenesis and tissue repair in preclinical models, that human orthopaedic data are lacking, and that both remain prohibited in sport.
Limitations. Narrative. Treats Tβ4 and TB-500 in one breath — the chemical distinction still has to be kept on the identity record.
DOI 10.1177/03635465251357593 · Mayfield et al., Am J Sports Med (2026) · Reviewed 12 September 2026
TB-500 · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026Regulatory listing
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position on TB-500.
- Endpoint investigated
- Compounding classification
Listed on FDA's withdrawn-nominations table. Published concerns include aggregation and immunogenicity risk; FDA notes it has not identified human exposure data. FDA and PubChem identify TB-500 as the LKKTETQ heptapeptide.
Limitations. Withdrawn nomination; not a clinical trial review. Human exposure data are stated as not identified.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
TB-500 · WADA 2026 Prohibited List
REGULATORY2026Anti-doping listing
World Anti-Doping Agency · WADA Prohibited List
- Objective
- To record the 2026 Prohibited List entry.
- Endpoint investigated
- Sporting prohibition status
Named at S2.3 — “Thymosin-β4 and its derivatives e.g. TB-500”. Prohibited at all times; non-Specified.
Limitations. Anti-doping classification. Groups the fragment with the parent molecule by name.
WADA 2026 Prohibited List · Reviewed 12 September 2026
Semaglutide · Wilding et al., N Engl J Med (2021) — STEP 1
CLINICAL TRIAL2021Randomised, double-blind, placebo-controlled trial
Wilding JPH, Batterham RL, Calanna S, et al. · New England Journal of Medicine
- Population
- Adults with overweight or obesity, without diabetes, in a registered Phase 3 programme
- Sample
- n = 1,961
- Objective
- To test once-weekly subcutaneous semaglutide 2.4 mg versus placebo for body-weight change in the STEP 1 trial.
- Endpoint investigated
- Body-weight change and related endpoints in STEP 1
Phase 3 randomised trial of the approved 2.4 mg weekly dose versus placebo in adults with overweight or obesity. Primary results were published in NEJM. This is labelled, approved-drug evidence — not research-chemical catalogue evidence.
Limitations. Trial population, dose, product and supervision are those of the approved drug programme. Findings do not transfer to unapproved look-alike products.
DOI 10.1056/NEJMoa2032183 · Wilding et al., N Engl J Med (2021) — STEP 1 · Reviewed 12 September 2026
Semaglutide · Marso et al., N Engl J Med (2016) — SUSTAIN-6
CLINICAL TRIAL2016Randomised, double-blind, placebo-controlled cardiovascular trial
Marso SP, Bain SC, Consoli A, et al. · New England Journal of Medicine
- Population
- Adults with type 2 diabetes at high cardiovascular risk
- Sample
- n = 3,297
- Objective
- To assess cardiovascular outcomes with once-weekly semaglutide in type 2 diabetes.
- Endpoint investigated
- Major adverse cardiovascular events in SUSTAIN-6
Cardiovascular outcomes trial of approved semaglutide in type 2 diabetes, published in NEJM. Part of the labelled evidence base for the approved products.
Limitations. Diabetes / high-CV-risk population; approved product. Not a statement about unapproved GLP-1 products.
DOI 10.1056/NEJMoa1607141 · Marso et al., N Engl J Med (2016) — SUSTAIN-6 · Reviewed 12 September 2026
Semaglutide · Drugs@FDA — approved drug products
REGULATORY2021Approved-drug labelling
U.S. Food and Drug Administration · Drugs@FDA
- Objective
- To record that three approved United States products exist, with application numbers.
- Endpoint investigated
- Marketing authorisation, not a new experimental endpoint
Ozempic approved 5 December 2017; Rybelsus 20 September 2019; Wegovy 4 June 2021. Labelling is the authoritative statement of approved indications and is not reproduced here as medical advice.
Limitations. Label indications are product-specific. They do not describe research-chemical catalogues.
Drugs@FDA — approved drug products · Reviewed 12 September 2026
Semaglutide · FDA — Concerns about unapproved GLP-1 drugs used for weight loss
REGULATORY2026Regulatory communication
U.S. Food and Drug Administration · FDA drug alerts and statements
- Objective
- To record FDA's published position on unapproved GLP-1 products.
- Endpoint investigated
- Regulatory status of unapproved GLP-1 products
FDA has issued communications concerning unapproved GLP-1 products marketed for weight loss, separate from the approved NDA products. The communication is about products that are not the labelled drugs.
Limitations. A safety communication is not a trial. It does not characterise any named research vendor.
FDA — Concerns about unapproved GLP-1 drugs used for weight loss · Reviewed 12 September 2026
Tirzepatide · Jastreboff et al., N Engl J Med (2022) — SURMOUNT-1
CLINICAL TRIAL2022Randomised, double-blind, placebo-controlled trial
Jastreboff AM, Aronne LJ, Ahmad NN, et al. · New England Journal of Medicine
- Population
- Adults with obesity, or overweight plus a weight-related complication, without diabetes
- Sample
- n = 2,539
- Objective
- To test once-weekly tirzepatide versus placebo for body-weight change in SURMOUNT-1.
- Endpoint investigated
- Body-weight change in the SURMOUNT-1 trial
Phase 3 randomised trial of approved tirzepatide doses versus placebo, published in NEJM. Evidence for the approved products, not for unapproved look-alikes.
Limitations. Approved-product trial. Population, dose and manufacture are those of the labelled programme.
DOI 10.1056/NEJMoa2206038 · Jastreboff et al., N Engl J Med (2022) — SURMOUNT-1 · Reviewed 12 September 2026
Tirzepatide · Frías et al., N Engl J Med (2021) — SURPASS-2
CLINICAL TRIAL2021Randomised, open-label, active-controlled trial
Frías JP, Davies MJ, Rosenstock J, et al. · New England Journal of Medicine
- Population
- Adults with type 2 diabetes
- Sample
- n = 1,879
- Objective
- To compare once-weekly tirzepatide with once-weekly semaglutide 1 mg on glycaemic endpoints in SURPASS-2.
- Endpoint investigated
- Glycaemic and related endpoints versus semaglutide 1 mg
Phase 3 active-controlled trial in type 2 diabetes, published in NEJM. Open-label. The comparator dose of semaglutide is 1 mg, which is not the 2.4 mg STEP dose.
Limitations. Open-label; diabetes population; comparator is semaglutide 1 mg, not 2.4 mg. Approved products only.
DOI 10.1056/NEJMoa2107519 · Frías et al., N Engl J Med (2021) — SURPASS-2 · Reviewed 12 September 2026
Tirzepatide · Drugs@FDA — approved drug products
REGULATORY2023Approved-drug labelling
U.S. Food and Drug Administration · Drugs@FDA
- Objective
- To record the two approved United States products.
- Endpoint investigated
- Marketing authorisation
Mounjaro approved 13 May 2022; Zepbound 8 November 2023. Sequence modifications and molecular weight are stated in the FDA-approved labelling.
Limitations. Labelled products only. Not a description of compounded copies.
Drugs@FDA — approved drug products · Reviewed 12 September 2026
Ipamorelin · Raun et al., Eur J Endocrinol (1998)
ANIMAL1998Preclinical pharmacology (in vitro and animal)
Raun K, Hansen BS, Johansen NL, et al. · European Journal of Endocrinology
- Population
- Pituitary in-vitro systems and animal GH-release models
- Objective
- To characterise ipamorelin as a growth-hormone secretagogue and compare selectivity with earlier GHRPs.
- Endpoint investigated
- GH release and selectivity versus cortisol, prolactin and ACTH in preclinical systems
Foundational pharmacology paper describing ipamorelin as a pentapeptide GH secretagogue with greater selectivity than earlier GHRPs in the systems tested. It is a characterisation study, not a human efficacy trial.
Limitations. Preclinical. Selectivity in these models is not a human safety or efficacy finding. No approved product exists.
DOI 10.1530/eje.0.1390552 · Raun et al., Eur J Endocrinol (1998) · Reviewed 12 September 2026
Ipamorelin · Gobburu et al., Pharm Res (1999)
CLINICAL TRIAL1999Human pharmacokinetic / pharmacodynamic study
Gobburu JV, Agersø H, Jusko WJ, Ynddal L · Pharmaceutical Research
- Population
- Healthy human volunteers in a PK/PD study
- Objective
- To model the pharmacokinetics of ipamorelin and its relationship to GH release in volunteers.
- Endpoint investigated
- PK/PD of GH release, not a therapeutic endpoint
Volunteer PK/PD study linking ipamorelin exposure to GH release. It shows a hormone-axis effect under experimental conditions. It does not test a clinical indication.
Limitations. Healthy volunteers; hormone biomarker, not a disease endpoint; small experimental programme by later Phase 3 standards. No approved product followed.
DOI 10.1023/A:1018955126402 · Gobburu et al., Pharm Res (1999) · Reviewed 12 September 2026
Ipamorelin · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2023Regulatory listing
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record the active Category 2 placement and FDA's published concerns.
- Endpoint investigated
- Compounding classification
Of the compounds in this library, ipamorelin acetate is the one currently on FDA's active 503B Category 2 table — bulk substances that may present significant safety risks when used in compounding. Published concerns include immunogenicity from aggregation and impurities, and characterisation of an API containing unnatural amino acids.
Limitations. Category 2 is a compounding-risk classification, not a completed clinical evidence review.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
Ipamorelin · WADA 2026 Prohibited List
REGULATORY2026Anti-doping listing
World Anti-Doping Agency · WADA Prohibited List
- Objective
- To record the 2026 Prohibited List entry.
- Endpoint investigated
- Sporting prohibition status
Named at S2.2.4 among growth hormone secretagogues. Prohibited at all times; non-Specified.
Limitations. Anti-doping classification only.
WADA 2026 Prohibited List · Reviewed 12 September 2026
CJC-1295 · Teichman et al., J Clin Endocrinol Metab (2006)
CLINICAL TRIAL2006Randomised, placebo-controlled study in healthy adults
Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA · Journal of Clinical Endocrinology & Metabolism
- Population
- Healthy adults
- Sample
- n = 49 (reported across dose groups in the paper)
- Objective
- To measure the duration of GH and IGF-1 elevation after CJC-1295 with DAC in healthy adults.
- Endpoint investigated
- GH and IGF-1 secretion over days after dosing
Placebo-controlled study of the DAC form of CJC-1295 in healthy adults, showing prolonged GH and IGF-1 elevation relative to placebo. The molecule studied is the albumin-binding DAC variant, not the non-DAC “Mod GRF 1-29” often sold under the same name.
Limitations. Healthy adults; hormone biomarkers, not a disease endpoint; DAC form only. Development did not produce an approved drug. A death in a later trial programme is discussed in subsequent reviews as a development event, not as a finding of this paper.
DOI 10.1210/jc.2005-1536 · Teichman et al., J Clin Endocrinol Metab (2006) — DAC form of CJC-1295. · Reviewed 12 September 2026
CJC-1295 · Ionescu and Frohman, J Clin Endocrinol Metab (2006)
CLINICAL TRIAL2006Human physiological study
Ionescu M, Frohman LA · Journal of Clinical Endocrinology & Metabolism
- Population
- Healthy adults
- Objective
- To test whether GH pulsatility was preserved during prolonged GHRH-receptor stimulation by CJC-1295 with DAC.
- Endpoint investigated
- Pulsatile GH secretion under DAC-CJC-1295
Companion physiology paper to Teichman 2006, reporting that pulsatile GH secretion persisted during continuous stimulation by the DAC analogue in the conditions studied.
Limitations. Small physiological study; DAC form; biomarker, not a clinical indication. Does not characterise the non-DAC molecule.
DOI 10.1210/jc.2006-1702 · Ionescu and Frohman, J Clin Endocrinol Metab (2006) · Reviewed 12 September 2026
CJC-1295 · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026Regulatory listing
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position.
- Endpoint investigated
- Compounding classification
Listed on the withdrawn-nominations table. FDA's published concerns reference serious adverse events reported in association with CJC-1295, including increased heart rate and systemic vasodilatory reaction. The entry does not distinguish DAC from non-DAC forms.
Limitations. FDA's entry does not resolve which chemical form a given commercial product is. Identity still has to be checked by formula on a certificate.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
CJC-1295 · WADA 2026 Prohibited List
REGULATORY2026Anti-doping listing
World Anti-Doping Agency · WADA Prohibited List
- Objective
- To record the 2026 Prohibited List entry.
- Endpoint investigated
- Sporting prohibition status
Named at S2.2.4 among GHRH analogues. Prohibited at all times; non-Specified.
Limitations. Anti-doping classification only.
WADA 2026 Prohibited List · Reviewed 12 September 2026
Sermorelin · Prakash and Goa, BioDrugs (1999)
REVIEW1999Drug review of the then-approved product
Prakash A, Goa KL · BioDrugs
- Population
- Paediatric GH-deficiency populations described in the GEREF literature
- Objective
- To review the approved sermorelin product (GEREF) as it stood in 1999.
- Endpoint investigated
- Diagnostic and paediatric GH-deficiency use of GEREF
Contemporary review of sermorelin acetate (GEREF) while it was an approved product. Useful as a map of the labelled-era literature. The product is now discontinued in the United States.
Limitations. Pre-discontinuation. Paediatric GH-deficiency context. No current FDA label is retrievable to verify indication wording, which the identity record already flags.
DOI 10.2165/00063030-199912020-00005 · Prakash and Goa, BioDrugs (1999) · Reviewed 12 September 2026
Sermorelin · Drugs@FDA — approved drug products
REGULATORY1997Approved-drug record (discontinued)
U.S. Food and Drug Administration · Drugs@FDA
- Objective
- To record former approval and current marketing status.
- Endpoint investigated
- Marketing status
GEREF (sermorelin acetate for injection), NDA 020443, originally approved 26 September 1997. Drugs@FDA records the marketing status as discontinued. There is no currently marketed approved sermorelin product in the United States.
Limitations. No current label. Approved indication wording is recorded on the identity page as unverifiable.
Drugs@FDA — approved drug products · Reviewed 12 September 2026
Sermorelin · WADA 2026 Prohibited List
REGULATORY2026Anti-doping listing
World Anti-Doping Agency · WADA Prohibited List
- Objective
- To record the 2026 Prohibited List entry.
- Endpoint investigated
- Sporting prohibition status
Named at S2.2.4 among GHRH analogues. Prohibited at all times; non-Specified.
Limitations. Anti-doping classification only.
WADA 2026 Prohibited List · Reviewed 12 September 2026
GHK-Cu · Pickart and Margolina, Int J Mol Sci (2018)
REVIEW2018Narrative review
Pickart L, Margolina A · International Journal of Molecular Sciences
- Objective
- To summarise gene-expression and tissue-repair literature on GHK and GHK-Cu.
- Endpoint investigated
- Reported cellular and dermal research findings
Open-access review by the originating GHK laboratory, collecting in-vitro and dermal research. It is the usual map of this literature. Cosmetic use of copper tripeptide-1 is a separate regulatory fact from drug approval.
Limitations. Narrative review from the originating group. Gene-expression changes in culture are not human clinical outcomes. Injectable drug use is not established; FDA's withdrawn compounding nomination is scoped to injectable routes.
DOI 10.3390/ijms19071987 · Pickart and Margolina, Int J Mol Sci (2018) · Reviewed 12 September 2026
GHK-Cu · Pickart, J Biomater Sci Polym Ed (2008)
REVIEW2008Narrative review
Pickart L · Journal of Biomaterials Science, Polymer Edition
- Objective
- To review GHK's reported effects on tissue remodeling.
- Endpoint investigated
- Tissue-remodeling literature, largely preclinical and dermal
Earlier review of GHK in tissue remodeling, again from the originating author. Useful historically; not independent replication.
Limitations. Single-author review of a literature the author generated much of. Not a controlled human interventional programme for systemic use.
DOI 10.1163/156856208784909435 · Pickart, J Biomater Sci Polym Ed (2008) · Reviewed 12 September 2026
GHK-Cu · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026Regulatory listing
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record that FDA's published compounding entry is scoped to injectable routes.
- Endpoint investigated
- Compounding classification for injectable routes
Listed on the withdrawn-nominations table, scoped specifically to injectable routes of administration. Published concerns include immunogenicity risk from aggregation and impurities, and limited human data. Cosmetic INCI use of Copper Tripeptide-1 is a different regulatory bucket.
Limitations. The FDA entry is route-scoped. It is not a review of topical cosmetic literature.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
Thymosin alpha-1 · King and Tuthill, Expert Opin Biol Ther (2016)
REVIEW2016Safety-focused review
King RS, Tuthill C · Expert Opinion on Biological Therapy
- Objective
- To review published safety information for thymosin alpha-1 / thymalfasin.
- Endpoint investigated
- Reported safety in jurisdictions where it has been used
Review of safety information for thymalfasin, which has been marketed in some jurisdictions outside the United States (for example as Zadaxin) and has no Drugs@FDA record of United States approval.
Limitations. Not a United States labelling document. Does not create a US approval. Safety literature from other jurisdictions is not a compounding justification.
DOI 10.1080/14712598.2016.1196183 · King and Tuthill, Expert Opin Biol Ther (2016) · Reviewed 12 September 2026
Thymosin alpha-1 · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026Regulatory listing
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position.
- Endpoint investigated
- Compounding classification
Nomination withdrawn. FDA's published concerns state that compounded thymosin alpha-1 may pose significant risk for immunogenicity, and that available safety information is inadequate for the agency to understand the extent of any safety issues. Not approved in the United States.
Limitations. US compounding classification. Non-US marketing is a separate fact.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
Thymosin alpha-1 · Drugs@FDA — approved drug products
REGULATORY2026Negative regulatory search
U.S. Food and Drug Administration · Drugs@FDA
- Objective
- To record the absence of a United States approval.
- Endpoint investigated
- Marketing authorisation (none found)
No record found in Drugs@FDA under thymalfasin. Not approved in the United States, though the substance is marketed in some other jurisdictions.
Limitations. Absence of a record is not a safety study.
Drugs@FDA — approved drug products · Reviewed 12 September 2026
Melanotan II · Dorr et al., Life Sci (1996)
CLINICAL TRIAL1996Pilot Phase I study
Dorr RT, Lines R, Levine N, et al. · Life Sciences
- Population
- Small adult volunteer cohort in a Phase I tanning study
- Objective
- To explore pigmentation and tolerability of melanotan-II in a pilot human study.
- Endpoint investigated
- Pigmentation and acute tolerability in a pilot cohort
Early human Phase I work on melanotan-II as a melanocortin peptide, reporting pigmentation and adverse effects in a small volunteer study. It is historical pharmacology, not an approved-product trial. No FDA-approved product exists.
Limitations. Pilot n; 1996 methods; not a contemporary safety database. Subsequent FDA compounding materials cite case reports of serious adverse events for this unapproved substance.
DOI 10.1016/0024-3205(96)00160-9 · Dorr et al., Life Sci (1996) · Reviewed 12 September 2026
Melanotan II · Hadley and Dorr, Peptides (2006)
REVIEW2006Narrative review
Hadley ME, Dorr RT · Peptides
- Objective
- To review melanocortin peptide development, including melanotan-II and related analogues.
- Endpoint investigated
- Development history of melanocortin peptides
Historical review of melanocortin peptide therapeutics by authors involved in the early programme. Distinguishes development paths that later produced an approved drug (bremelanotide) from melanotan-II, which did not.
Limitations. Author-involved narrative. Does not replace later FDA materials on unapproved melanotan-II.
DOI 10.1016/j.peptides.2005.01.029 · Hadley and Dorr, Peptides (2006) · Reviewed 12 September 2026
Melanotan II · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026Regulatory listing
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position.
- Endpoint investigated
- Compounding classification and cited case reports
Nomination withdrawn. FDA's published entry references case reports of serious adverse events, including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism. Melanotan II is the C-terminal amide; bremelanotide is the free acid.
Limitations. Case reports cited by FDA are not a randomised trial. They are a regulatory concern list.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
Bremelanotide · Kingsberg et al., Obstet Gynecol (2019) — RECONNECT
CLINICAL TRIAL2019Two randomised, double-blind, placebo-controlled Phase 3 trials
Kingsberg SA, Clayton AH, Portman D, et al. · Obstetrics & Gynecology
- Population
- Premenopausal women with hypoactive sexual desire disorder, as enrolled in RECONNECT
- Sample
- n = 1,247 combined (RECONNECT 301 and 302)
- Objective
- To test subcutaneous bremelanotide versus placebo on labelled endpoints in the RECONNECT programme.
- Endpoint investigated
- Co-primary endpoints of the approved-product Phase 3 programme
The two RECONNECT Phase 3 trials supporting the approved product Vyleesi. Population, dose form (autoinjector) and endpoints are those of the labelled programme.
Limitations. Approved-product trials in a specific labelled population. Not evidence about melanotan II, despite near-identical mass.
DOI 10.1097/AOG.0000000000003500 · Kingsberg et al., Obstet Gynecol (2019) — RECONNECT · Reviewed 12 September 2026
Bremelanotide · Drugs@FDA — approved drug products
REGULATORY2019Approved-drug labelling
U.S. Food and Drug Administration · Drugs@FDA
- Objective
- To record United States approval.
- Endpoint investigated
- Marketing authorisation
VYLEESI, NDA 210557, approved 21 June 2019. Active prescription product administered by subcutaneous autoinjector. Not listed on FDA compounding Category 2 or withdrawn-nomination tables.
Limitations. Labelled product only.
Drugs@FDA — approved drug products · Reviewed 12 September 2026
Tesamorelin · Falutz et al., N Engl J Med (2007)
CLINICAL TRIAL2007Randomised, double-blind, placebo-controlled trial
Falutz J, Allas S, Blot K, et al. · New England Journal of Medicine
- Population
- HIV-infected adults with excess abdominal fat (lipodystrophy programme)
- Sample
- n = 412
- Objective
- To test tesamorelin versus placebo on visceral adipose tissue in HIV-associated lipodystrophy.
- Endpoint investigated
- Visceral adipose tissue and related metabolic measures
Pivotal randomised trial of tesamorelin in HIV-associated excess abdominal fat, published in NEJM, in the development programme that led to EGRIFTA. This is approved-drug evidence in a labelled population.
Limitations. HIV lipodystrophy population; approved product. Not a general “GH peptide” outcome study and not evidence for CJC-1295 or ipamorelin.
DOI 10.1056/NEJMoa070689 · Falutz et al., N Engl J Med (2007) · Reviewed 12 September 2026
Tesamorelin · Drugs@FDA — approved drug products
REGULATORY2010Approved-drug labelling
U.S. Food and Drug Administration · Drugs@FDA
- Objective
- To record United States approval.
- Endpoint investigated
- Marketing authorisation
EGRIFTA, BLA 022505, approved 10 November 2010. Currently marketed approved GHRH analogue in this library. Labelling is the authoritative statement of the approved indication.
Limitations. Labelled product and population only.
Drugs@FDA — approved drug products · Reviewed 12 September 2026
Tesamorelin · WADA 2026 Prohibited List
REGULATORY2026Anti-doping listing
World Anti-Doping Agency · WADA Prohibited List
- Objective
- To record the 2026 Prohibited List entry.
- Endpoint investigated
- Sporting prohibition status
Named at S2.2.4 among GHRH analogues. Prohibited at all times; non-Specified. Sporting prohibition coexists with a United States drug approval — the two systems answer different questions.
Limitations. Anti-doping classification is independent of FDA approval.
WADA 2026 Prohibited List · Reviewed 12 September 2026
Selank · Kolomin et al., Neurosci Med (2013)
REVIEW2013Narrative review of the originating programme
Kolomin T, Shadrina M, Slominsky P, Limborska S, Myasoedov N · Neuroscience & Medicine
- Objective
- To summarise the Russian regulatory-peptide programme that includes selank (tuftsin analogue TP-7).
- Endpoint investigated
- Preclinical and limited clinical literature of that programme
Review from the originating network describing synthetic peptides based on natural regulatory peptides, including the tuftsin analogue selank. Useful as a map of that literature. Western independent trials are scarce.
Limitations. Originating-group review. Not a systematic review of independent RCTs. No United States approved product.
DOI 10.4236/nm.2013.44035 · Kolomin et al., Neurosci Med (2013) · Reviewed 12 September 2026
Selank · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026Regulatory listing
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position.
- Endpoint investigated
- Compounding classification
Listed as “Selank acetate (TP-7)” on the withdrawn-nominations table. Published concerns include aggregation and immunogenicity risk, and that the nomination lacked important information regarding safety issues. Not named on the WADA 2026 Prohibited List.
Limitations. US compounding classification. Does not evaluate the Russian-language clinical corpus in detail.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
Epitalon · Khavinson et al., Bull Exp Biol Med (2003)
IN VITRO2003In vitro (cultured human somatic cells)
Khavinson VKh, Bondarev IE, Butyugov AA · Bulletin of Experimental Biology and Medicine
- Population
- Cultured human somatic cells (originating laboratory)
- Objective
- To test whether the AEDG tetrapeptide induced telomerase activity and telomere elongation in culture.
- Endpoint investigated
- Telomerase activity and telomere length in cultured cells
Foundational in-vitro paper from Khavinson's group reporting that epithalon induced telomerase activity and telomere elongation in cultured human somatic cells. This is the paper popular claims about “telomerase activation” point at.
Limitations. Cell culture, not a living human. Does not show systemic delivery, tissue distribution, or a lifespan endpoint. Single-laboratory origin. A later independent in-vitro replication (Al-Dulaimi et al., 2025) is still cell-culture data.
DOI 10.1023/A:1025493705728 · Khavinson et al., Bull Exp Biol Med (2003) · Reviewed 12 September 2026
Epitalon · Khavinson and Morozov, Neuro Endocrinol Lett (2003)
HUMAN DATA2003Report of long-term observations — pineal/thymic extracts
Khavinson V, Morozov V · Neuro Endocrinology Letters
- Population
- Elderly patients in a Russian clinical programme
- Objective
- To report long-term observations after pineal and thymic peptide preparations.
- Endpoint investigated
- Mortality and related observations in that programme
Often cited in popular epitalon writing. The preparations in this paper are pineal and thymic peptide preparations (epithalamin / thymalin extracts) used in a long-term observational programme — not a Western RCT of synthetic AEDG (epitalon).
Limitations. Extract preparations are not the synthetic tetrapeptide. Observational, originating group, not independently replicated as a synthetic-epitalon RCT. Do not treat this as Phase 3 evidence for AEDG.
Khavinson and Morozov, Neuro Endocrinol Lett (2003) — Epithalamin/thymalin extracts, not synthetic epitalon. · Reviewed 12 September 2026
Epitalon · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026Regulatory listing
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position.
- Endpoint investigated
- Compounding classification
Listed on the withdrawn-nominations table, citing aggregation and impurity immunogenicity risk and absence of safety information. Considered at FDA's Pharmacy Compounding Advisory Committee meeting of 24 July 2026. Committee recommendations reported in the trade press are not an FDA decision and are not recorded here as one.
Limitations. Identity record remains a withdrawn nomination until FDA publishes minutes and any rulemaking. Secondary vote tallies disagree in places (STAT vs Regulatory Focus on epitalon).
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
BPC-157 · Tewari et al., Am J Sports Med (2026)
REVIEW2026Scoping review
Tewari K, Liu TP, Im C, Hamad C, Petrigliano F, Cheung EC, Kremen TJ · The American Journal of Sports Medicine
- Objective
- To scope peer-reviewed data on BPC-157, TB-500/Tβ4, CJC-1295, ipamorelin and GHK-Cu in musculoskeletal models.
- Endpoint investigated
- Published musculoskeletal evidence, animal and human
PRISMA-guided scoping review. Reports that about two-thirds of identified publications used preclinical animal models, and that human clinical studies were limited and mostly lacked robust controls. Concludes that claimed benefits for musculoskeletal recovery remain unsubstantiated by current human trials.
Limitations. Scoping, not a meta-analysis of effect sizes. Groups TB-500 with Tβ4 in the search.
DOI 10.1177/03635465261464420 · Tewari et al., Am J Sports Med (2026) · Reviewed 12 September 2026
TB-500 · Tewari et al., Am J Sports Med (2026)
REVIEW2026Scoping review
Tewari K, Liu TP, Im C, Hamad C, Petrigliano F, Cheung EC, Kremen TJ · The American Journal of Sports Medicine
- Objective
- To scope musculoskeletal literature that uses TB-500 / thymosin β-4 search terms.
- Endpoint investigated
- Published musculoskeletal evidence
Same scoping review as the BPC-157 row. Search terms combined TB-500 with thymosin β-4. Human clinical studies were described as limited.
Limitations. Search conflates the fragment and the parent molecule. Identity caveat on the TB-500 record still applies.
DOI 10.1177/03635465261464420 · Tewari et al., Am J Sports Med (2026) · Reviewed 12 September 2026
Ipamorelin · Mendias and Awan, Sports Med (2026)
REVIEW2026Narrative review
Mendias CL, Awan TM · Sports Medicine
- Objective
- To contrast approved peptide drugs with unapproved compounds marketed in sports medicine.
- Endpoint investigated
- Published safety/efficacy and regulatory status
Sports Medicine review of approved and unapproved peptides marketed for injury and performance, including ipamorelin. Frames many unapproved peptides as having favourable animal findings and scarce rigorous human safety data.
Limitations. Narrative. Not a substitute for primary PK papers.
DOI 10.1007/s40279-026-02437-0 · Mendias and Awan, Sports Med (2026) · Reviewed 12 September 2026
CJC-1295 · Mendias and Awan, Sports Med (2026)
REVIEW2026Narrative review
Mendias CL, Awan TM · Sports Medicine
- Objective
- To place CJC-1295 among unapproved peptides marketed in sports medicine.
- Endpoint investigated
- Published safety/efficacy and regulatory status
Same 2026 Sports Medicine review, covering CJC-1295 as an unapproved GHRH analogue with animal and limited human pharmacology and no approved indication.
Limitations. Narrative. Does not replace Teichman/Ionescu primary papers.
DOI 10.1007/s40279-026-02437-0 · Mendias and Awan, Sports Med (2026) · Reviewed 12 September 2026
GHK-Cu · Mayfield et al., Am J Sports Med (2026)
REVIEW2026Narrative review
Mayfield CK, Bolia IK, Feingold CL, Lin EH, Liu JN, Hatch GFR, Gamradt SC, Weber AE · The American Journal of Sports Medicine
- Objective
- To assess whether GHK-Cu has clinical data for musculoskeletal conditions.
- Endpoint investigated
- Human musculoskeletal evidence
Reports that GHK-Cu has preclinical wound-healing and anti-inflammatory literature, and that no clinical data support its use for musculoskeletal conditions.
Limitations. Orthopaedic lens; does not review topical cosmetic literature in depth.
DOI 10.1177/03635465251357593 · Mayfield et al., Am J Sports Med (2026) · Reviewed 12 September 2026
AOD-9604 · Stier, Vos and Kenley, J Endocrinol Metab (2013)
CLINICAL TRIAL2013Summary of six randomised, double-blind, placebo-controlled trials
Stier H, Vos E, Kenley D · Journal of Endocrinology and Metabolism
- Population
- Human volunteers in six sponsor-run randomised trials
- Objective
- To summarise safety and tolerability observations for AOD-9604 across six randomised trials, with attention to IGF-1, glucose handling and antibodies.
- Endpoint investigated
- IGF-1, oral glucose tolerance, anti-AOD9604 antibodies, withdrawals and serious adverse events as reported by the authors
The authors summarise six randomised, double-blind, placebo-controlled trials of AOD-9604. They report no effect on serum IGF-1, no negative effect on carbohydrate metabolism in oral glucose-tolerance testing, no anti-AOD9604 antibodies in assayed subjects, and no withdrawal or serious adverse event they judged related to the peptide. The paper is a pooled safety narrative, not an FDA-reviewed efficacy programme.
Limitations. Sponsor-linked authors (Metabolic Pharmaceuticals / Calzada). Trial-level n, protocols and full adverse-event tables are not independently reproduced here. A tolerability summary is not an approved indication.
DOI 10.4021/jem157w · Stier, Vos and Kenley, J Endocrinol Metab (2013) · Reviewed 12 September 2026
AOD-9604 · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026FDA compounding classification
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position on AOD-9604.
- Endpoint investigated
- Compounding classification, not efficacy
AOD-9604 appears on FDA's table of bulk substances nominated for compounding and withdrawn by the nominator. Published concerns include immunogenicity risk, peptide-related impurities, API characterisation complexity, limited safety information, and serious adverse events whose causality FDA states is not clear.
Limitations. A withdrawn nomination is not a safety assessment of any particular material, and it is not a clinical evidence review.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
AOD-9604 · WADA 2026 Prohibited List
REGULATORY2026Anti-doping listing
World Anti-Doping Agency · WADA Prohibited List
- Objective
- To record the 2026 Prohibited List entry.
- Endpoint investigated
- Sporting prohibition status
Named at S2.2.3 as an example of a growth-hormone fragment, alongside hGH 176-191. Prohibited at all times; non-Specified. This is an anti-doping classification, not a finding about laboratory research use.
Limitations. WADA listing is not a determination of chemical identity or of any research endpoint.
WADA 2026 Prohibited List · Reviewed 12 September 2026
KPV · Dalmasso et al., Gastroenterology (2008)
ANIMAL2008In vitro with in-vivo murine colitis models
Dalmasso G, Charrier-Hisamuddin L, Nguyen HT, Yan Y, Sitaraman S, Merlin D · Gastroenterology
- Population
- Cultured intestinal epithelial and immune cells; DSS- and TNBS-induced colitis in mice
- Objective
- To test whether PepT1 transports KPV and whether oral KPV altered chemically induced colitis in mice.
- Endpoint investigated
- NF-κB and MAP-kinase signalling in culture; histological and cytokine measures in murine colitis
Reports that nanomolar KPV inhibited NF-κB and MAP-kinase inflammatory signalling in cultured cells via hPepT1, and that oral KPV in drinking water reduced measures of DSS- and TNBS-induced colitis in mice. The work is a primary source for the preclinical gut-inflammation literature on this tripeptide.
Limitations. Murine chemical-colitis models and cell culture. Findings do not establish human inflammatory-bowel outcomes.
DOI 10.1053/j.gastro.2007.10.026 · Dalmasso et al., Gastroenterology (2008) · Reviewed 12 September 2026
KPV · Kannengiesser et al., Inflamm Bowel Dis (2008)
ANIMAL2008In vivo (murine colitis)
Kannengiesser K, et al. · Inflammatory Bowel Diseases
- Population
- Two murine colitis models, including MC1R-mutant mice
- Objective
- To test KPV in two murine colitis models and whether effects required MC1R signalling.
- Endpoint investigated
- Colitis severity and survival in mice
Reports anti-inflammatory effects of KPV in two murine colitis models, described as at least partly independent of MC1R signalling. In MC1R-mutant mice, the authors report that KPV treatment rescued animals in the treatment group from death during DSS colitis.
Limitations. Rodent IBD models. Rescue of survival in a mutant-mouse DSS model is not a human clinical endpoint.
DOI 10.1002/ibd.20334 · Kannengiesser et al., Inflamm Bowel Dis (2008) · Reviewed 12 September 2026
KPV · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026FDA compounding classification
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position on KPV.
- Endpoint investigated
- Compounding classification
KPV appears on FDA's withdrawn-nominations table. FDA states it has not identified any human exposure data on drug products containing KPV via any route, and that it lacks information on whether the drug would cause harm if administered to humans.
Limitations. Withdrawn nomination; not a clinical trial review. Human exposure data are stated as not identified.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
KPV · FDA — PCAC briefing for KPV-related bulk drug substances
REGULATORY2026FDA advisory-committee briefing
U.S. Food and Drug Administration · FDA PCAC briefing
- Objective
- To record FDA staff's published proposal on 503A Bulks List inclusion for KPV.
- Endpoint investigated
- Proposed compounding-list classification
PCAC discussed KPV (free base) and KPV acetate on 23 July 2026 (uses evaluated: wound healing and inflammatory conditions). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed. A committee recommendation is not a listing decision.
Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review.
FDA — PCAC briefing for KPV-related bulk drug substances · Reviewed 12 September 2026
MOTS-c · Lee et al., Cell Metab (2015)
ANIMAL2015In vivo (mouse) with supporting cellular work
Lee C, Zeng J, Drew BG, Sallam T, Martin-Montalvo A, Wan J, Kim SJ, Mehta H, Hevener AL, de Cabo R, Cohen P · Cell Metabolism
- Population
- Mice, including diet-induced obesity models
- Objective
- To characterise MOTS-c, a 16-residue peptide encoded by mitochondrial 12S rRNA, in metabolic-homeostasis models.
- Endpoint investigated
- Metabolic-homeostasis measures in mice, including obesity and insulin-resistance models
Identifies MOTS-c as a mitochondrial ORF-encoded peptide and reports that it promoted metabolic homeostasis and reduced obesity and insulin resistance in the mouse systems tested. This is the originating primary paper for the MOTS-c literature, not a human interventional trial.
Limitations. Mouse and cellular systems. CB4211 and other analogues are distinct molecules and are not this compound. Findings do not establish human metabolic outcomes.
DOI 10.1016/j.cmet.2015.02.009 · Lee et al., Cell Metab (2015) · Reviewed 12 September 2026
MOTS-c · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026FDA compounding classification
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position on MOTS-c.
- Endpoint investigated
- Compounding classification
MOTS-c (styled MOTs-C on the table) appears on FDA's withdrawn-nominations table. Published concerns include immunogenicity risk, peptide-related impurities and API characterisation. FDA states it has not identified human exposure data.
Limitations. Withdrawn nomination; not a clinical trial review.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
MOTS-c · FDA — PCAC briefing for MOTS-c-related bulk drug substances
REGULATORY2026FDA advisory-committee briefing
U.S. Food and Drug Administration · FDA PCAC briefing
- Objective
- To record FDA staff's published proposal on 503A Bulks List inclusion for MOTS-c.
- Endpoint investigated
- Proposed compounding-list classification
PCAC discussed MOTS-c (free base) and MOTS-c acetate on 23 July 2026 (uses evaluated: obesity and osteoporosis). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed.
Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review.
FDA — PCAC briefing for MOTS-c-related bulk drug substances · Reviewed 12 September 2026
Semax · Dolotov et al., J Neurochem (2006)
ANIMAL2006In vivo (rat) with supporting binding work
Dolotov OV, et al. · Journal of Neurochemistry
- Population
- Rat basal forebrain after intranasal application
- Objective
- To test whether Semax binds in rat basal forebrain and alters BDNF protein after intranasal application.
- Endpoint investigated
- BDNF protein in rat basal forebrain versus cerebellum
Reports specific binding sites for Semax in rat basal forebrain and a rapid increase in BDNF protein there, but not in cerebellum, after intranasal application at 50 and 250 µg/kg. The paper is mechanistic rodent work, not a United States clinical programme.
Limitations. Rodent BDNF biochemistry. Intranasal application in rats is not a labelled human indication, and the United States has no approved Semax product.
DOI 10.1111/j.1471-4159.2006.03658.x · Dolotov et al., J Neurochem (2006) · Reviewed 12 September 2026
Semax · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026FDA compounding classification
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position on Semax.
- Endpoint investigated
- Compounding classification
Semax (heptapeptide) appears on FDA's withdrawn-nominations table. Published concerns include immunogenicity risk from aggregation and peptide-related impurities, and limited safety information for the proposed routes.
Limitations. Withdrawn nomination; not a review of non-US labelled use.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
Semax · FDA — PCAC briefing for Semax-related bulk drug substances
REGULATORY2026FDA advisory-committee briefing
U.S. Food and Drug Administration · FDA PCAC briefing
- Objective
- To record FDA staff's published proposal on 503A Bulks List inclusion for Semax.
- Endpoint investigated
- Proposed compounding-list classification
PCAC discussed Semax (free base) and Semax acetate on 24 July 2026 (uses evaluated: cerebral ischemia, migraine and trigeminal neuralgia). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed.
Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review.
FDA — PCAC briefing for Semax-related bulk drug substances · Reviewed 12 September 2026
Emideltide · Schoenenberger and Monnier, Proc Natl Acad Sci USA (1977)
ANIMAL1977Isolation, synthesis and in-vivo rabbit EEG assay
Schoenenberger GA, Monnier M · Proceedings of the National Academy of Sciences
- Population
- Rabbits, intraventricular infusion, neocortical and archicortical EEG
- Sample
- 58 rabbits including controls
- Objective
- To isolate, sequence, synthesise and test a nonapeptide reported to enhance delta and spindle EEG after intraventricular infusion.
- Endpoint investigated
- Delta and spindle EEG patterns in rabbits
Reports isolation from rabbits of a nonapeptide Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu, named delta-sleep-inducing peptide, and that among nine synthetic peptides tested under double-blind conditions only the synthetic nonapeptide showed significant enhancement of delta and spindle EEG. This is the originating characterisation paper, not a human sleep trial.
Limitations. Rabbit intraventricular EEG model. Later literature has debated whether an endogenous human DSIP of this sequence is established. The experiment does not speak to United States compounding policy.
DOI 10.1073/pnas.74.3.1282 · Schoenenberger and Monnier, Proc Natl Acad Sci USA (1977) · Reviewed 12 September 2026
Emideltide · FDA — Certain bulk drug substances for use in compounding may present significant safety risks
REGULATORY2026FDA compounding classification
U.S. Food and Drug Administration · FDA compounding communications
- Objective
- To record FDA's published compounding position on emideltide.
- Endpoint investigated
- Compounding classification
Emideltide (DSIP) appears on FDA's withdrawn-nominations table. Published concerns include immunogenicity risk, peptide-related impurities and API characterisation, and absence of identified safety information for the proposed route.
Limitations. Withdrawn nomination; not a clinical trial review.
FDA — Certain bulk drug substances for use in compounding may present significant safety risks · Reviewed 12 September 2026
Emideltide · FDA — PCAC briefing for emideltide-related bulk drug substances
REGULATORY2026FDA advisory-committee briefing
U.S. Food and Drug Administration · FDA PCAC briefing
- Objective
- To record FDA staff's published proposal on 503A Bulks List inclusion for emideltide.
- Endpoint investigated
- Proposed compounding-list classification
PCAC discussed emideltide (free base) and emideltide acetate on 24 July 2026 (uses evaluated: opioid withdrawal, chronic insomnia and narcolepsy). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed.
Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review. Secondary press about committee votes is not used as an identity or listing fact.
FDA — PCAC briefing for emideltide-related bulk drug substances · Reviewed 12 September 2026
Retatrutide · Jastreboff et al., N Engl J Med (2023)
CLINICAL TRIAL2023Randomised, double-blind, placebo-controlled Phase 2 trial
Jastreboff AM, Kaplan LM, Frías JP, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman ML; Retatrutide Phase 2 Obesity Trial Investigators · New England Journal of Medicine
- Population
- Adults with obesity in a registered Phase 2 programme
- Sample
- n = 338
- Objective
- To test once-weekly retatrutide versus placebo for body-weight change over 48 weeks.
- Endpoint investigated
- Body-weight change and related endpoints in Phase 2
Phase 2 randomised trial of investigational retatrutide, a GIP/GLP-1/glucagon receptor agonist, versus placebo in adults with obesity. Primary results were published in NEJM. This is investigational-drug evidence under medical supervision — not research-chemical catalogue evidence, and not an approved-product label.
Limitations. Phase 2. Product, dose and supervision are those of the sponsor programme. Findings do not transfer to unapproved look-alike products, and they do not make retatrutide interchangeable with semaglutide or tirzepatide.
DOI 10.1056/NEJMoa2301972 · Jastreboff et al., N Engl J Med (2023) · Reviewed 12 September 2026
Retatrutide · Eli Lilly — TRIUMPH-1 topline news release (21 May 2026)
CLINICAL TRIAL2026Sponsor Phase 3 topline disclosure
Eli Lilly and Company · Company news release
- Population
- Adults with obesity or overweight and at least one weight-related comorbidity, without diabetes, in TRIUMPH-1
- Objective
- To disclose topline Phase 3 body-weight results for retatrutide in TRIUMPH-1.
- Endpoint investigated
- Percent change in body weight at 80 weeks as reported by the sponsor
On 21 May 2026 Lilly disclosed topline TRIUMPH-1 results. The release reports that the 4 mg, 9 mg and 12 mg once-weekly arms met primary and key secondary endpoints, with a stated 80-week mean body-weight change of 28.3% at 12 mg under the efficacy estimand. The disclosure is a sponsor communication, not a peer-reviewed paper, and retatrutide remains investigational.
Limitations. Topline company disclosure. Estimands, full adverse-event tables and the statistical analysis plan are not independently reproduced here. A peer-reviewed TRIUMPH-1 paper was not identified at review. Not an FDA approval.
Eli Lilly — TRIUMPH-1 topline news release (21 May 2026) · Reviewed 12 September 2026
BPC-157 · FDA — PCAC briefing for BPC-157-related bulk drug substances
REGULATORY2026FDA advisory-committee briefing
U.S. Food and Drug Administration · FDA PCAC briefing
- Objective
- To record FDA staff's published proposal on 503A Bulks List inclusion for BPC-157.
- Endpoint investigated
- Proposed compounding-list classification
PCAC discussed BPC-157 (free base) and BPC-157 acetate on 23 July 2026 (use evaluated: ulcerative colitis). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed. A committee recommendation is not a listing decision.
Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review.
FDA — PCAC briefing for BPC-157-related bulk drug substances · Reviewed 12 September 2026
TB-500 · FDA — PCAC briefing for TB-500-related bulk drug substances
REGULATORY2026FDA advisory-committee briefing
U.S. Food and Drug Administration · FDA PCAC briefing
- Objective
- To record FDA staff's published proposal on 503A Bulks List inclusion for TB-500.
- Endpoint investigated
- Proposed compounding-list classification
PCAC discussed TB-500 (free base) and TB-500 acetate on 23 July 2026 (use evaluated: wound healing). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed.
Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review.
FDA — PCAC briefing for TB-500-related bulk drug substances · Reviewed 12 September 2026
Epitalon · FDA — PCAC briefing for Epitalon-related bulk drug substances
REGULATORY2026FDA advisory-committee briefing
U.S. Food and Drug Administration · FDA PCAC briefing
- Objective
- To record FDA staff's published proposal on 503A Bulks List inclusion for Epitalon.
- Endpoint investigated
- Proposed compounding-list classification
PCAC discussed Epitalon (free base) and Epitalon acetate on 24 July 2026 (use evaluated: insomnia). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed.
Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review.
FDA — PCAC briefing for Epitalon-related bulk drug substances · Reviewed 12 September 2026
