Cagrilintide regulatory status
Current status of Cagrilintide in the United States: Not eligible for compounding. 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 Cagrilintide?
Regulatory: Not eligible for compoundingWADA: WADA prohibitedVerified: Verified Sep 27, 2026
- FDA and compounding
- Not FDA approved as of the last verification date, either alone or in the fixed combination with semaglutide. Because cagrilintide is not a component of an approved drug, has no USP monograph, and is not on the 503A bulks list, it cannot lawfully be compounded. Any product sold as cagrilintide or CagriSema outside a clinical trial is an unapproved drug. Check FDA for the status of any marketing application before relying on this record.
- WADA
- WADA prohibited
- Access path
- No lawful United States access path identified on the last verified date outside a registered clinical trial.
- Not available as an FDA approved product and not eligible for compounding under section 503A or 503B while investigational.
- Products labeled research use only are not lawful for human use and are not verified for identity or purity.
Full Cagrilintide page: evidence, dosing in the literature, and sources
How has the status of Cagrilintide changed over time?
No dated regulatory event has been recorded for Cagrilintide. That usually means no FDA, PCAC, Federal Register, or WADA action has named it specifically. Category-wide actions are listed on the tracker hub.
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for Cagrilintide and the source of each dated event.