PLAINSBORO, N.J. — Novo Nordisk has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for CagriSema, a once-weekly injectable combination therapy for chronic weight management that pairs a GLP-1 receptor agonist with an amylin analogue.
If approved, CagriSema would become the first fixed-dose injectable combination of semaglutide and the novel amylin analogue cagrilintide. The therapy is designed for use alongside a reduced-calorie diet and increased physical activity in adults with obesity or overweight who have at least one weight-related comorbidity.
The FDA submission is backed by data from Novo Nordisk’s phase 3 REDEFINE clinical program. In the 68-week REDEFINE 1 trial, adults with obesity or overweight without diabetes who continued treatment lost an average of 22.7% of their body weight with CagriSema, compared to 2.3% for placebo. When analyzing outcomes regardless of treatment adherence, patients on CagriSema achieved an average weight loss of 20.4%, versus 3.0% for placebo.
More than 90% of participants treated with CagriSema achieved at least 5% weight loss, and a secondary analysis showed that about half of patients with baseline obesity reached a body mass index below the obesity threshold by week 68.
Novo Nordisk stated that safety results from the REDEFINE 1 and REDEFINE 2 trials were consistent with the GLP-1 drug class, with most adverse events being gastrointestinal. Discontinuation rates due to adverse events were less than 10% in both studies.
“The FDA submission of CagriSema marks an important milestone and signals a new era in weight management,” said Mike Doustdar, president and CEO of Novo Nordisk, in a statement. He added that the combination therapy has the potential to expand treatment options by targeting complementary biological pathways involved in obesity.
The FDA is expected to review the application in 2026. CagriSema is not currently approved in the United States or the European Union.
Novo Nordisk continues to invest heavily in its obesity pipeline as demand for effective weight management therapies accelerates across healthcare and retail pharmacy channels, with potential implications for prescription volume, payer coverage, and in-store health engagement.
