Novo Nordisk Files FDA Application for Next-Generation Obesity Drug CagriSema

Novo Nordisk has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for its next-generation obesity treatment, CagriSema, a once-weekly injectable combining cagrilintide and semaglutide. The FDA review is expected in 2026 and, if successful, would mark a significant advance in chronic weight-management therapies.

Combination Approach Targets Enhanced Weight Loss

CagriSema blends Novo’s established GLP-1 receptor agonist semaglutide with a novel amylin analogue, cagrilintide, to address complementary metabolic pathways and potentially offer greater efficacy than single-agent therapies. In the phase 3 REDFINE program, the combination delivered an average weight loss of about 20% over 68 weeks, supporting its promise as a potent option for adults with obesity or overweight with comorbidities.

Strategic Implications in a Competitive Obesity Market

The submission comes as the obesity drug market rapidly expands, with CagriSema positioned to enhance Novo Nordisk’s leadership amid intensifying competition from other GLP-1 and combination therapies. If approved, CagriSema would be the first fixed-dose GLP-1-amylin combination for weight management, reinforcing innovation and diversifying treatment options beyond established injectables and newly emerging oral agents.