U.S. Food and Drug Administration (FDA)
Is Cagrilintide (and CagriSema) legal in United States?
Under reviewNot approved alone; Novo Nordisk's CagriSema (cagrilintide plus semaglutide) is under FDA review for obesity, and cagrilintide cannot be compounded
A regulator is actively reviewing it.
Novo Nordisk reported in February 2026 that it had submitted a New Drug Application to FDA for CagriSema for adults with overweight or obesity, and its August 2026 report lists a US decision on CagriSema among its anticipated 2026 regulatory milestones. Nothing is approved yet. FDA states that cagrilintide cannot be used in compounding under federal law and is not a component of any FDA-approved drug. US customs officers also seized cagrilintide among unapproved peptide shipments in 2026.
Last verified 2026-09-29 · how we verify
Cagrilintide (and CagriSema) elsewhere
Sources (4)
- 01Novo Nordisk financial report for 2025 (Form 6-K, company announcement)Novo Nordisk A/S (SEC filing) · 2026-02-03 · accessed 2026-09-29
- 02Novo Nordisk financial report for the period 1 January to 30 June 2026 (Form 6-K)Novo Nordisk A/S (SEC filing) · 2026-08-04 · accessed 2026-09-29
- 03FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration · 2026-09-01 · accessed 2026-09-29
- 04Cincinnati CBP foils scheme to smuggle over 5,000 unapproved peptides into the U.S.U.S. Customs and Border Protection · 2026-03-31 · accessed 2026-09-29