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Sermorelin regulatory status

Current status of Sermorelin in the United States: Regulatory status unknown. In sport: WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Sermorelin?

Regulatory: Regulatory status unknownWADA: WADA prohibitedVerified: Verified Sep 23, 2026
FDA and compounding
There is no currently approved sermorelin product in the United States. Geref (sermorelin acetate) was approved as a diagnostic on December 28, 1990 (NDA 19-863) and for treatment of idiopathic growth hormone deficiency in children on September 26, 1997 (NDA 20-443); the sponsor discontinued both in 2008 and FDA withdrew the approvals effective June 18, 2009. In March 2013 FDA determined in the Federal Register that Geref was not withdrawn for reasons of safety or effectiveness, which allows generic applications. Sermorelin was not placed on the 503A Category 2 list in 2023 and is not on the 503A bulks list; many 503A pharmacies compound it on the basis of the former approval, and whether that satisfies the component of an approved drug condition depends on how a state board and the pharmacy read it. Compounded sermorelin for adult anti-aging, fat loss, or sleep is an unapproved use with no supporting trial.
WADA
WADA prohibited
Access path
  1. Prescription from a licensed provider filled by a state licensed 503A compounding pharmacy, commonly through telehealth clinics.
  2. No FDA approved product is currently marketed (Geref was withdrawn in 2009).
  3. Products labeled research use only are not lawful for human use and are not verified for purity.

Full Sermorelin page: evidence, dosing in the literature, and sources

How has the status of Sermorelin changed over time?

  1. WADA

    WADA publishes the 2027 Prohibited List

    WADA published the 2027 Prohibited List on September 21, 2026, and it takes effect January 1, 2027. The S2 peptide hormone and growth factor classes are unchanged. BPC-157 is still named under S0, and MOTS-c is still named under S4.4 as an activator of AMP-activated protein kinase. WADA added a note that many peptides without approval for human use fall under S0 or another section, and that a peptide not named on the list may still be prohibited. GLP-1 receptor agonists such as semaglutide and tirzepatide are still not on the list.

    Source: WADA 2027 Prohibited List
  2. WADA

    WADA 2026 Prohibited List takes effect

    The 2026 WADA Prohibited List took effect on January 1, 2026 and continues to prohibit the S2 peptide hormone and growth factor classes (GHRH analogs, growth hormone secretagogues, GH fragments, IGF-1 and analogs, MGF, thymosin beta-4 and derivatives, hCG and GnRH-class releasing factors in males), myostatin inhibitors, insulin and the AMPK activator MOTS-c under S4, desmopressin under S5, and BPC-157 under S0. GLP-1 receptor agonists such as semaglutide and tirzepatide are not on the list.

    Source: WADA Prohibited List
  3. WADA

    WADA 2025 Prohibited List keeps peptide hormones and growth factors banned at all times

    The 2025 WADA Prohibited List took effect on January 1, 2025. Section S2 (peptide hormones, growth factors, related substances and mimetics) covers GHRH analogs such as CJC-1295, sermorelin, and tesamorelin, growth hormone secretagogues such as ipamorelin, GHRP-2, GHRP-6, hexarelin, and ibutamoren (MK-677), growth hormone fragments such as AOD-9604, growth factors including IGF-1 and its analogs, MGF, and thymosin beta-4 (TB-500), and chorionic gonadotropin and releasing factors such as gonadorelin and kisspeptin (prohibited in males). Myostatin inhibitors such as ACE-031 fall under S4, insulin under S4 metabolic modulators, desmopressin under S5, and BPC-157 remains an S0 non-approved substance.

    Source: WADA Prohibited List

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Sermorelin and the source of each dated event.

  1. [1]Federal Register, March 4, 2013: Determination that Geref (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness (NDA 19-863 and NDA 20-443)Federal Register, 2013
  2. [2]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (503A bulks list, Category 1, 2, and 3 lists)FDA, 2026
  3. [3]WADA Prohibited List, section S2 (growth hormone releasing hormone and its analogues, including sermorelin)WADA, 2026
  4. [4]WADA 2027 Prohibited ListWADA, 2026

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