| Filing
Novo Nordisk submitted CagriSema, a weekly combination of semaglutide and cagrilintide, for FDA approval for weight management. The filing is based on the REDEFINE 1 trial, in which people lost 20.4% of body weight versus 3.0% on placebo over 68 weeks counting everyone randomized, and 22.7% versus 2.3% for those who stayed on treatment.
Novo said the FDA is expected to review the application in 2026 and did not give a decision date.
Worth knowing: As of the Atlas check, the Atlas has not confirmed an FDA approval of CagriSema. It is not an approved product.
Related: Pipeline | Trial results explorer | Medicine library
Source: Novo Nordisk press release, December 18, 2025, via BioSpace. Company announcement; not peer reviewed Company announcement, not peer reviewed. Remy Research, last checked October 12, 2026. Third-party tracker citing Novo Nordisk statements; secondary source Trade press, secondary source.