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Therapept

Stabilised GHRH analogue — human GHRH(1-44) amide, N-terminally acylated

Tesamorelin — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

3 records in this file

  • CLINICAL TRIAL1
  • REGULATORY2

Research areas. Anti-doping; Approved-drug Phase 3; United States approval.

Publication span. 2007–2026.

What we know

  • FDA-approved as EGRIFTA (BLA 022505, 2010). Falutz et al. 2007 (NEJM) is a primary interventional paper in the HIV-lipodystrophy programme.
  • It is the only GHRH analogue in this library with a currently marketed United States approval.
  • Also named on the WADA GHRH-analogue list — approval and sporting prohibition are different questions.

Editorial reading of the records below, labelled as Therapept analysis. How records are built

What remains uncertain

  • Orthopaedic or “performance” endpoints: 2026 sports-medicine reviews report no supporting evidence in those settings.

Regulatory notes

FDA-approved drug substance

  • EGRIFTA, BLA 022505, approved 10 November 2010. Active prescription product.
  • Not listed on FDA's Category 2 or withdrawn-nomination compounding tables.

Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.

Studies and documents

  1. REGULATORY2026Anti-doping listing

    WADA Prohibited List — S2.2.4 GHRH analogues

    World Anti-Doping AgencyWADA 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 ListReviewed 12 September 2026

  2. REGULATORY2010Approved-drug labelling

    Drugs@FDA — EGRIFTA (BLA 022505)

    U.S. Food and Drug AdministrationDrugs@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 productsReviewed 12 September 2026

  3. CLINICAL TRIAL2007Randomised, double-blind, placebo-controlled trial

    Metabolic effects of a growth hormone-releasing factor in patients with HIV

    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/NEJMoa070689Falutz et al., N Engl J Med (2007)Reviewed 12 September 2026

Last reviewed 3 September 2026 · Compiled by Therapept Editorial · How these records are built