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Novo Nordisk Files FDA Application for CagriSema: A New Era in Weight Management

Published: December 19, 2025

In a major move to solidify its leadership in the obesity market, Novo Nordisk officially submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on December 18, 2025, for CagriSema.

CagriSema is a once-weekly injectable fixed-dose combination of two powerful medications:

  • Semaglutide (2.4 mg): The GLP-1 receptor agonist found in Wegovy.
  • Cagrilintide (2.4 mg): A novel long-acting amylin analogue.

Key Highlights from the FDA Submission

The application is primarily backed by the REDEFINE 1 clinical trial, which involved over 3,400 adults. The results demonstrated superior weight loss compared to using either component alone:

Treatment Group Avg. Weight Loss (68 Weeks)
CagriSema 22.7% — 23%
Semaglutide alone 16.1%
Cagrilintide alone 11.8%
Placebo 2.3%

Why CagriSema Matters

If approved, CagriSema would become the first injectable combination of a GLP-1 and an amylin analogue. By targeting two different satiety pathways, it aims to provide a more holistic and potent treatment for chronic weight management and type 2 diabetes.

"The submission signals a new era in weight management... CagriSema has the potential to represent a meaningful step forward in the holistic treatment of obesity."
— Mike Doustdar, President and CEO of Novo Nordisk

What’s Next?

The FDA is expected to review the application throughout 2026. While the trial results slightly missed the company's internal 25% "stretch goal," the data remains robust enough to position CagriSema as a formidable competitor to Eli Lilly’s Zepbound and future therapies like retatrutide.

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