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Is Cagrilintide legal? FDA status and US regulatory standing
Current status
Investigational. Cagrilintide is an investigational compound in active clinical trials, not yet FDA-approved.
Primary source: clinicaltrials.gov
Federal legal status
FDA approval status
Cagrilintide is an investigational compound in active clinical trials, not yet FDA-approved. Amylin analog by Novo Nordisk. Phase 3 as CagriSema (+ semaglutide, NCT05669755) for obesity. Not yet approved. NDA submission anticipated 2026-2027 if trials succeed.
Also known as
AM833 · CagriSema
Frequently asked questions
- Is Cagrilintide FDA approved?
- Cagrilintide is an investigational compound in active clinical trials, not yet FDA-approved. Primary source linked on this page.
- Is Cagrilintide legal to buy?
- Cagrilintide is available in the U.S. as a research-use-only compound. It is an investigational compound in active clinical trials, not yet FDA-approved. Sale for human consumption is not permitted.
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Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .