Novo Nordisk Seeks US FDA Approval for Once-weekly Weight Loss Drug CagriSema

08:45 AM EST, 12/18/2025 (MT Newswires) -- Novo Nordisk (NOVO-B.CO) submitted a new drug application to the US Food and Drug Administration for its investigational weight-loss medicine CagriSema's use in adults with obesity or overweight with at least one weight-related comorbidity. The once-weekly injectable drug is intended to be used alongside a reduced-calorie diet and increased physical activity, according to a Thursday release by the Danish drugmaker. The application included data from the phase 3 Redefine 1 trial, in which the CagriSema patient group showed a weight loss of 20.4% at 68 weeks versus 3% in the placebo. The US FDA will review the application in 2026.