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Gonadorelin regulatory status

Current status of Gonadorelin in the United States: FDA approved. 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 Gonadorelin?

Regulatory: FDA approvedWADA: WADA prohibitedVerified: Verified Sep 23, 2026
FDA and compounding
Gonadorelin was the active ingredient of two FDA approved human products, Factrel (gonadorelin hydrochloride, a diagnostic for pituitary function) and Lutrepulse (gonadorelin acetate for pump delivered ovulation induction), both of which have been discontinued in the United States for commercial rather than safety reasons. Because it is a component of FDA approved drugs, 503A pharmacies can compound it under a prescription, which is why it is widely available as a compounded testosterone therapy adjunct. As a 10 amino acid peptide it was not affected by the March 2020 transition of hCG and other large proteins to biologic status, so it filled the gap when compounded hCG became unavailable. It is not on the FDA Category 2 list. The currently marketed FDA approved gonadorelin products are veterinary.
WADA
WADA prohibited
Access path
  1. Prescription from a reproductive endocrinologist with a portable infusion pump for ovulation or spermatogenesis induction (compounded drug, since the approved products are discontinued).
  2. Prescription filled by a 503A compounding pharmacy as subcutaneous vials, usually through testosterone telehealth clinics.
  3. Not available as an FDA approved human product at present.

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

How has the status of Gonadorelin 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 Gonadorelin and the source of each dated event.

  1. [1]Drugs@FDA database (search gonadorelin for the discontinued Factrel and Lutrepulse approvals)FDA, 2026
  2. [2]FDA: Compounding and the FDA, questions and answers (including that biological products cannot be compounded under 503A or 503B)FDA, 2026
  3. [3]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 list and withdrawn nominations, current as of April 22, 2026)FDA, 2026
  4. [4]WADA Prohibited List, section S2 peptide hormones, growth factors, related substances and mimeticsWADA, 2026
  5. [5]WADA 2027 Prohibited ListWADA, 2026