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Therapept

GHRH analogue — human GHRH (1-29) amide

Sermorelin — 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

  • REVIEW1
  • REGULATORY2

Research areas. Anti-doping; Discontinued approved product; United States approval.

Publication span. 1997–2026.

What we know

  • GEREF (NDA 020443) was approved in 1997 and is recorded in Drugs@FDA as discontinued.
  • A 1999 review maps the labelled-era paediatric GH-deficiency literature. No current FDA label is retrievable.
  • WADA lists GHRH analogues, including this one.

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

What remains uncertain

  • Exact approved-indication wording, because no current label is retrievable — already flagged on the identity record.
  • What, if anything, currently marketed research-use material has in common with discontinued GEREF.

Regulatory notes

Formerly approved — discontinued

  • 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.
  • Not listed on FDA's Category 2 or withdrawn-nomination compounding tables.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.

    Limitations. Anti-doping classification only.

    WADA 2026 Prohibited ListReviewed 12 September 2026

  2. REVIEW1999Drug review of the then-approved product

    Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency

    Prakash A, Goa KLBioDrugs

    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 10.2165/00063030-199912020-00005Prakash and Goa, BioDrugs (1999)Reviewed 12 September 2026

  3. REGULATORY1997Approved-drug record (discontinued)

    Drugs@FDA — GEREF (NDA 020443), marketing status discontinued

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

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