LL-37 regulatory status
Current status of LL-37 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 LL-37?
- FDA and compounding
- Not an FDA approved drug. LL-37 was placed on the FDA 503A Category 2 list (bulk substances with significant safety risks) in 2023 and was one of the peptides FDA now lists as withdrawn from 503A Category 2 (page current as of April 22, 2026) after the nominations were withdrawn. It was not among the peptides the Pharmacy Compounding Advisory Committee recommended for the 503A bulks list at its July 23 to 24, 2026 meeting, so it currently sits in neither category and most 503A pharmacies will not compound it. Not eligible for 503B outsourcing.
- WADA
- WADA prohibited
- Access path
- Not available as an FDA approved product.
- It is off Category 2 but not on the 503A bulks list, so a 503A pharmacy has no federal basis to compound it from bulk.
- Products labeled research use only are not lawful for human use and are not verified for purity.
Full LL-37 page: evidence, dosing in the literature, and sources
How has the status of LL-37 changed over time?
- 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FDA lists BPC-157 and 16 other peptides as withdrawn from 503A Category 2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selank, semax, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) to a list of bulk drug substances nominated but withdrawn by their nominators. A withdrawn substance is no longer in 503A Category 2, but withdrawal is not an approval and does not place a substance on the 503A bulks list; a 503A pharmacy still needs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 Seven of the withdrawn peptides (BPC-157, KPV, TB-500, MOTS-c, semax, epitalon, and DSIP) were taken to the Pharmacy Compounding Advisory Committee in July 2026.
- 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 LL-37 and the source of each dated event.
- [1]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
- [2]FDA Pharmacy Compounding Advisory Committee meetings (July 2026 meeting on peptide nominations)FDA, 2026
- [3]WADA Prohibited List, section S0 non-approved substancesWADA, 2026
- [4]FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)FDA, 2026