Epitalon
Epitalon is studied as a synthetic tetrapeptide in biochemical and physiological models.
Epitalon Biological Classification
Investigated within physiological and chemical models.
What is Epitalon?
Epitalon is classified as a synthetic tetrapeptide. A synthetic tetrapeptide with no approved drug product. It is distinct from Epithalamin, a pineal extract, with which it is sometimes conflated in supplier documentation.
Why are people interested in it?
Researchers and clinicians study Epitalon primarily to understand its biological interactions, receptor binding affinity, and potential role within its biochemical class.
Primary Research Categories
- Peptide fragments
- Preclinical research compounds
How does it work in the body?
Epitalon interacts with specific cellular receptors and metabolic pathways corresponding to its structural classification as a synthetic tetrapeptide.
Biological Pathway Overview
Epitalon Receptor & Target Interactions
This compound is evaluated in scientific research for its interactions with target cellular receptors and signaling cascades. Consult the evidence section below for specific peer-reviewed papers.
Target Pathway
Engages specific cellular signaling cascades characteristic of its structural family.
Endocrine/Paracrine Activity
Investigated for its regulatory effects on local tissue synthesis and cellular signaling.
What has actually been demonstrated in humans?
Evidence for Epitalon is currently derived primarily from laboratory or preclinical models. Consult the published evidence file for specific indexed studies.
Pharmaceutical Reality vs. Unregulated Research Chemicals
Epitalon is not an FDA-approved medication. Always verify chemical identity and testing documentation before interpreting research literature.
What is still uncertain or unknown?
Controlled human clinical trials evaluating Epitalon for therapeutic efficacy, safety, and pharmacokinetics are limited or absent in peer-reviewed Western registries.
Companion Resources & Guides
Clinical Perspectives & Expert Discussions
Explore all perspectivesWhat identifiable clinicians, researchers, and professional bodies have publicly discussed regarding Epitalon.
Dr. Brad Stanfield, MBChB
MBChB (University of Auckland School of Medicine); registered General Practitioner in New Zealand; clinical trial investigator and medical educator.
Dr. Stanfield provides critical appraisal of popular biohacking peptides (notably BPC-157, TB-500, and Epitalon), highlighting that the overwhelming majority of claims circulate on rodent and cell-culture data that have never been verified in rigorous human randomized controlled trials. He warns that online suppliers often sell unpurified chemicals with significant batch variability and unknown long-term human toxicity.
Research at a Glance
Open the full evidence file (4 records)4 records in this file
- HUMAN DATA1
- IN VITRO1
- REGULATORY2
Publication span: 2003–2026
What Has Actually Been Studied
- FDA PCAC briefing — Epitalon-related bulk drug substances (24 July 2026) (FDA PCAC briefing, 2026) — FDA advisory-committee briefing.
- FDA table of bulk drug substances nominated for compounding and subsequently withdrawn (FDA compounding communications, 2026) — Regulatory listing.
- Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells (Bulletin of Experimental Biology and Medicine, 2003) — In vitro (cultured human somatic cells).
- Peptides of pineal gland and thymus prolong human life (Neuro Endocrinology Letters, 2003) — Report of long-term observations — pineal/thymic extracts.
What is Still Unknown
What we know
- The 2003 Khavinson in-vitro paper reports telomerase activity and telomere elongation in cultured human somatic cells.
- Popular “human lifespan” citations often point at extract programmes (epithalamin), which are not the synthetic AEDG tetrapeptide.
- No US approved product. Withdrawn compounding nomination. Distinct from Epithalamin (different CAS association in PubChem).
Editorial reading of the records below, labelled as Therapept analysis. How records are built
What remains uncertain
- Independent in-vivo human interventional data on synthetic AEDG.
- Whether in-vitro telomerase findings have a defined relationship to organism-level ageing endpoints.
- FDA's eventual decision on the July 2026 PCAC recommendation — a committee vote is not a listing.
Preparation and Handling
Lyophilized peptides ship as freeze-dried powders; whatever happens next involves diluents, concentrations and storage conditions that are compound- and product-specific.
United States Regulatory Status
No FDA-approved product
- No approved drug product exists in Drugs@FDA.
- Listed on FDA's table of bulk substances nominated for compounding and withdrawn by the nominator, citing aggregation and impurity immunogenicity risk and absence of safety information.
- On 24 July 2026 PCAC discussed Epitalon (free base) and Epitalon acetate (use evaluated: insomnia). FDA briefing materials proposed that they NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed. Committee recommendations are non-binding; FDA has not published a listing decision as of this review.
- Not named on the WADA 2026 Prohibited List.
Technical Chemical SpecificationsClick to view CAS, sequence, and molecular formulas
- Molecular weight
- 390.35 g/mol
- Sequence length
- 4 chars
- CAS number
- 307297-39-8
- PubChem CID
- 219042
- Compound class
- Synthetic tetrapeptide
- Sequence
- AEDG
- Molecular formula
- C14H22N4O9
- Molecular weight
- 390.35 g/mol
- CAS number
- 307297-39-8
- PubChem CID
- 219042
Sources
Last reviewed 12 September 2026 · Compiled by Therapept Editorial · How these records are built