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DEC 22 2026
UPCOMING · 202 DAYS TO PDUFA

Novo Nordisk CagriSema (cagrilintide + semaglutide) $NVO

for chronic weight management

NDA · Standard Review

Accepted FEB 22 2026.

About

Obesity is a chronic condition where the body struggles to maintain a healthy weight, often requiring long-term lifestyle changes to manage. CagriSema combines semaglutide, which mimics a gut hormone to curb appetite, with cagrilintide, a synthetic version of a natural hormone that slows stomach emptying and enhances fullness. Together, these mechanisms may help patients achieve sustained weight loss by targeting multiple pathways involved in hunger and metabolism.

Pivotal trial

REDEFINE 6 Phase 3 completed NCT05996848

This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide

Source: ClinicalTrials.gov

Also in development