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Novo files marketing application for next-gen weight-loss drug

By Thomson Reuters Dec 18, 2025 | 7:06 AM

Dec 18 (Reuters) – Novo Nordisk said on Thursday it ‍had filed a marketing application with the U.S. Food and Drug Administration for ‌CagriSema, its once-weekly ‌next-generation weight-loss drug.

The regulator is expected to review the application in 2026, ​Novo said.

The Danish drugmaker had ‍positioned CagriSema ​as a more ​potent successor to ‍its blockbuster drug, Wegovy, but lower-than-expected weight loss in two prior studies disappointed ‍investors.

The drug combines cagrilintide, which mimics pancreatic hormone ‍amylin, ‍and semaglutide, ​the active ingredient ​in ⁠Novo’s blockbuster weight-loss ‌drug Wegovy.

(Reporting by Christy Santhosh in Bengaluru; Editing by Shilpi Majumdar; Editing by Anil ⁠D’Silva)