CagriSema is the development name for the cagrilintide–semaglutide combination. It combines amylin and GLP-1 pathways and has Phase 3 trial evidence.
REDEFINE 1 studied adults without diabetes, while REDEFINE 2 studied adults with type 2 diabetes. Their average weight changes concern different populations. Treatment-policy results also need to be distinguished from estimates assuming continued treatment.
A marketing application is not an approval. The September 2026 sponsor status is current evidence of development, not an independent regulator decision.
This record is not advice to combine separate semaglutide and cagrilintide products. FDA identifies concerns about unapproved products, and a seller’s use of the development name cannot establish equivalence to the trial combination.
Regulatory status checked on 3 October 2026
United States: Sponsor announced an FDA application on 18 December 2025 and still described CagriSema as investigational on 30 September 2026. Subsequent FDA approval has not been verified.
European Union: EU marketing authorisation has not been verified in this review. No claim of an approved EU combination product is made.
Official records and primary evidence
- CagriSema US application announcement — Novo Nordisk
- September 2026 CagriSema development status — Novo Nordisk (sponsor)
- REDEFINE 1 combination-treatment trial — REDEFINE 1 investigators / NEJM
- REDEFINE 2 trial in type 2 diabetes — REDEFINE 2 investigators / NEJM
- FDA GLP-1 safety communication — FDA
Route and frequency describe approved product records or clinical-trial protocols as identified above. They are not instructions to use, obtain, combine, or dose a medicine. This record is informational and has not been independently medically reviewed.