Novo Nordisk Seeks FDA Approval for CagriSema, a Weekly Obesity Treatment
- Novo Nordisk submitted a New Drug Application to the FDA for CagriSema on Dec. 18, 2025.
- CagriSema combines cagrilintide 2.4 mg and semaglutide 2.4 mg.
- In the REDEFINE 1 phase 3 trial, CagriSema users lost an average of 23% body weight.
FDA Submission
Novo Nordisk has submitted a New Drug Application to the U.S. Food and Drug Administration for CagriSema, a once-weekly injectable treatment for obesity. The application was filed on December 18, 2025.
Composition and Mechanism
CagriSema is a fixed-dose combination of two active ingredients: cagrilintide, a novel amylin analogue, and semaglutide, a GLP-1 receptor agonist. Each component is dosed at 2.4 mg.
Clinical Trial Results
In the REDEFINE 1 phase 3 trial, adults with obesity or overweight, who also had at least one obesity-related complication, experienced an average weight loss of 23% when using CagriSema. This result was observed when evaluating the treatment effect assuming all patients remained on the treatment.
Intended Use
If approved, CagriSema will be used alongside a reduced-calorie diet and increased physical activity to help reduce excess body weight and maintain weight reduction in adults with obesity or overweight, particularly those with at least one weight-related comorbid condition.
Source: Novo Nordisk