Is CagriSema legal in the US?
Not yet; it is still in trials.
CagriSema is not approved by the FDA for any use as of 2026-10-26. Novo Nordisk reported submitting it to the FDA for weight management, and the application is under review; no product name has been approved. 3
No. As of October 2026 it is under FDA review. Novo Nordisk disclosed the submission in its fourth-quarter 2025 report. Until the FDA decides, there is no approved product, no label and no legal prescription. 3
Not legally in the United States. The drug has no approval. The FDA has stated that semaglutide and similar GLP-1 drugs cannot be compounded when the approved product is not in shortage. Anything sold online under the name is unregulated. 63
More on CagriSema
Citations
- StatPearls: Glucagon-like peptide-1 receptor agonists ncbi.nlm.nih.gov
- Lau 2021, Lancet: once-weekly cagrilintide for weight management, phase 2 doi.org
- Novo Nordisk Q4 2025 report to the SEC: CagriSema submission sec.gov
- Garvey 2025, NEJM: coadministered cagrilintide and semaglutide (REDEFINE 1) pubmed.ncbi.nlm.nih.gov
- Davies 2025, NEJM: cagrilintide-semaglutide in type 2 diabetes (REDEFINE 2) pubmed.ncbi.nlm.nih.gov
- FDA: concerns with unapproved GLP-1 drugs used for weight loss fda.gov
- Jastreboff 2022, NEJM: tirzepatide once weekly for obesity (SURMOUNT-1) pubmed.ncbi.nlm.nih.gov
- Novo Nordisk 6-K, February 2026: REDEFINE 4 headline results sec.gov
- Novo Nordisk 6-K, December 2024: REDEFINE 1 headline results sec.gov
- 2024, Diabetes Obes Metab: cagrilintide thorough QT study pubmed.ncbi.nlm.nih.gov
- 2024, Diabetes Obes Metab: lean body mass changes with GLP-1-based therapies pubmed.ncbi.nlm.nih.gov
- DailyMed: Wegovy (semaglutide) prescribing information dailymed.nlm.nih.gov
Reference information only, not medical advice. Drawn from the CagriSema article, fact-checked against the cited sources. No dosing anywhere on this site.