Novo Nordisk's cagrilintide-semaglutide combination is expected to get an FDA decision before year-end, though a missed head-to-head goal against tirzepatide hangs over its prospects.
Novo Nordisk filed CagriSema, a weekly injection pairing the long-acting amylin analog cagrilintide with semaglutide, in December 2025 for chronic weight management. Neither the company nor the FDA has publicly confirmed a PDUFA date, but a decision is widely expected in the fourth quarter of 2026.
The application leans on the REDEFINE program, in which CagriSema produced roughly 20% to 23% average weight loss at 68 weeks depending on the analysis, more than either component alone. However, the combination did not show non-inferiority to tirzepatide 15 mg in a head-to-head comparison, a result analysts expect to shape how it is positioned if approved.
Until a decision is issued, CagriSema is not an approved or prescribable product. The outcome will be an important test of whether amylin-pathway peptides can carve out a role alongside established GLP-1 and dual-agonist drugs.
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