Ipamorelin regulatory status
Current status of Ipamorelin in the United States: Removed from Category 2 (Apr 2026). 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 Ipamorelin?
- FDA and compounding
- Not FDA approved for any use and never approved anywhere. FDA placed ipamorelin (free base and acetate) on the 503A Category 2 list on September 29, 2023, citing immunogenicity risk, peptide related impurities, and lack of safety data for the compounded routes. The nominators withdrew the 503A nominations in September 2024 and FDA's April 2026 update moved it to the list of nominated but withdrawn substances rather than Category 1 or the bulks list. Ipamorelin acetate also remains in 503B Category 2 (added September 29, 2023) on the FDA page current as of April 22, 2026. It was not among the peptides the Pharmacy Compounding Advisory Committee reviewed in July 2026. Because it has no active nomination, is not on the 503A bulks list, and is not a component of an approved drug, licensed 503A pharmacies and 503B outsourcing facilities have no lawful basis to compound it.
- WADA
- WADA prohibited
- Access path
- Not legally available through a licensed pharmacy (no active 503A nomination, not on the bulks list, not an approved drug).
- Clinics that still advertise compounded ipamorelin are dispensing outside FDA's stated categories; ask what the legal basis is.
- Products labeled research use only are not lawful for human use.
Full Ipamorelin page: evidence, dosing in the literature, and sources
Is Ipamorelin FDA approved or legal? Questions and answers
Is ipamorelin FDA approved?
No. Ipamorelin is not FDA approved for any use and has never been approved anywhere. It was not among the peptides the Pharmacy Compounding Advisory Committee reviewed in July 2026, so no approval or compounding listing is pending. [1] [2]
What is the FDA status of ipamorelin in 2026?
Removed from Category 2 for 503A, but still blocked. FDA placed ipamorelin on the 503A Category 2 list on September 29, 2023, the nominators withdrew in 2024, and FDA's April 2026 update moved it to the nominated but withdrawn list rather than the bulks list. Ipamorelin acetate also remains in 503B Category 2 on the FDA page current as of April 22, 2026. [2] [3]
Is ipamorelin legal?
There is no lawful way to obtain ipamorelin for human use in the United States. It is not an approved drug, has no active 503A nomination, and is not on the bulks list, so neither 503A pharmacies nor 503B outsourcing facilities may compound it. Clinics that still advertise compounded ipamorelin are dispensing outside FDA's stated categories. [2] [3]
Is ipamorelin banned by WADA?
Yes. Ipamorelin is named in section S2 of the WADA Prohibited List among growth hormone secretagogues and is prohibited at all times, in and out of competition. [4]
How has the status of Ipamorelin changed over time?
- 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.
- FDA
FDA lists BPC-157 and 16 other peptides as withdrawn from 503A Category 2
FDA's Category 2 page, revised in April 2026 and current as of April 22, 2026, moved BPC-157, AOD-9604, CJC-1295, dihexa, DSIP, epitalon, injectable GHK-Cu, ipamorelin, KPV, LL-37, melanotan II, MOTS-c, PEG-MGF, selank, semax, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) to a list of bulk drug substances nominated but withdrawn by their nominators. A withdrawn substance is no longer in 503A Category 2, but withdrawal is not an approval and does not place a substance on the 503A bulks list; a 503A pharmacy still needs a listing before it may compound it. Ipamorelin acetate remains in 503B Category 2. Seven of the withdrawn peptides (BPC-157, KPV, TB-500, MOTS-c, semax, epitalon, and DSIP) were taken to the Pharmacy Compounding Advisory Committee in July 2026.
- 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.
- 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.
- FDA
FDA places GHRP-2, GHRP-6, and ipamorelin in 503B Category 2
On September 29, 2023 FDA added growth hormone releasing peptide-2 (GHRP-2, for injectable and nasal routes), GHRP-6, and ipamorelin acetate to Category 2 under the 503B interim policy, citing immunogenicity risk from aggregation and peptide related impurities and, for GHRP-2, reports of serious adverse events. Outsourcing facilities may not compound a substance while it is in 503B Category 2. All three remain listed on the FDA page current as of April 22, 2026.
- FDA
FDA places a batch of nominated peptides in 503A Category 2
In September 2023 FDA updated its 503A bulk drug substances category lists to place a group of nominated peptides in Category 2, which means FDA identified significant safety risks and the substances may not be used in 503A compounding while the evaluation continues. Kisspeptin-10 and ibutamoren (MK-677) were added on September 29, 2023 and remain in Category 2 on the FDA page current as of April 22, 2026. BPC-157, CJC-1295, ipamorelin, AOD-9604, dihexa, DSIP, epitalon, KPV, MOTS-c, selank, semax, melanotan II, LL-37, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) were also placed in Category 2 under the 503A interim policy; that same page now lists them as nominated but withdrawn (see the April 2026 event). Hexarelin, PNC-27, and 5-amino-1MQ have never appeared on the FDA category lists.
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for Ipamorelin and the source of each dated event.
- [1]FDA Pharmacy Compounding Advisory Committee meetings (July 2026 meeting on peptide nominations)FDA, 2026
- [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, and withdrawn nominations)FDA, 2026
- [3]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (503A Category 2 list and nominated but withdrawn substances, current as of April 22, 2026)FDA, 2026
- [4]WADA Prohibited List, section S2 (growth hormone secretagogues, including ipamorelin)WADA, 2026
- [5]WADA 2027 Prohibited ListWADA, 2026
From the blog
- Tesamorelin vs sermorelin vs ipamorelin: evidence and legality
Tesamorelin, sermorelin, and ipamorelin compared in one table: mechanism, FDA approval, compounding status, human evidence, and WADA status, with links to each pairwise comparison.