CagriSema
Also called: cagrilintide semaglutide
Clinical reviewer: Jacob Moore, MD · Last checked September 16, 2026
What is CagriSema?
CagriSema is an investigational once-weekly combination of the amylin analog cagrilintide and the GLP-1 medicine semaglutide, dosed together at 2.4 mg each. It is not FDA-approved, and Novo Nordisk filed a New Drug Application for it with the FDA on December 18, 2025.
What is CagriSema made of?
CagriSema is a fixed-dose combination of the long-acting amylin analogue cagrilintide, 2.4 mg, and the GLP-1 receptor agonist semaglutide, 2.4 mg, given as a single once-weekly injection [1][2]. Novo Nordisk pairs the two so that amylin and GLP-1 signaling act together rather than through semaglutide alone [2].
What did the REDEFINE 1 trial show?
In REDEFINE 1, a 68-week phase 3 trial of 3,417 adults without diabetes, cagrilintide-semaglutide produced an estimated 20.4% mean body weight reduction versus 3.0% with placebo [1]. Gastrointestinal side effects, mainly transient and mild to moderate, affected 79.6% of the cagrilintide-semaglutide group compared with 39.9% on placebo [1].
Is CagriSema FDA-approved?
No. Novo Nordisk filed a New Drug Application for CagriSema on December 18, 2025, for adults with obesity or overweight with at least one weight-related condition, and an FDA decision is anticipated by late 2026 [3]. CagriSema is "not approved in the US or EU" [2], and FDA states that cagrilintide cannot be used in compounding under federal law [4].
Related terms
Sources
- Garvey WT et al — Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (NEJM, 2025)
- Novo Nordisk press release — Novo Nordisk files for FDA approval of CagriSema
- Novo Nordisk company announcement — REDEFINE 4 results; FDA decision on CagriSema anticipated by late 2026 (February 23, 2026)
- FDA — FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
This entry is for education and is not medical advice. Talk with a licensed clinician about your own situation before starting, stopping, or changing any treatment.
