Novo Nordisk Files CagriSema, a GLP-1/Amylin Combination, for FDA Review

Novo Nordisk said on December 18, 2025 that it had submitted a New Drug Application to the FDA for CagriSema, a once-weekly subcutaneous injection that combines semaglutide 2.4 mg with cagrilintide 2.4 mg. If approved, the company said, it would be the first fixed-dose injectable combination of a GLP-1 receptor agonist and an amylin analogue for chronic weight management. The application sought use in adults with obesity, or overweight with at least one weight-related comorbid condition, alongside a reduced-calorie diet and increased physical activity.

The two components act through different pathways. Semaglutide, already marketed as Wegovy and Ozempic, is a GLP-1 receptor agonist, while cagrilintide is a long-acting analogue of amylin, a hormone co-secreted with insulin that influences satiety. Novo Nordisk has positioned the pairing as a way to combine complementary mechanisms in a single weekly injection.

The filing was supported by the REDEFINE Phase 3 program. In REDEFINE 1, which enrolled adults with obesity or overweight with a related complication, participants treated with CagriSema lost an average of about 20.4% of body weight, rising to 22.7% under an analysis assuming full adherence, compared with roughly 3% for placebo. The company reported that 91.9% of CagriSema participants achieved at least 5% weight loss. Safety findings were described as consistent with the GLP-1 class, with gastrointestinal effects the most common adverse events and discontinuation rates due to adverse events below 10%.

The results arrived against a mixed backdrop. When REDEFINE 1 first read out in December 2024, the roughly 22.7% figure fell short of the higher weight-loss level some analysts had anticipated, and the readout weighed on the company's share price at the time. The subsequent regulatory filing represented the next step in bringing the combination toward a potential U.S. launch.

Novo Nordisk's chief executive, Mike Doustdar, characterized the submission as a milestone in the company's weight-management portfolio. The FDA was expected to review the application during 2026; as of the filing, CagriSema had not been approved in the United States or the European Union, and no approved use exists. The trial figures describe study outcomes and should not be read as a claim about any authorized treatment.