Novo Nordisk submitted a US New Drug Application for CagriSema in December 2025. The investigational weekly injection combines cagrilintide and semaglutide for weight management, backed by the company's REDEFINE Phase 3 trials.
What is known.
Novo said in September 2026 that it expected an FDA decision in the fourth quarter. Submission and trial results are established milestones; US approval has not yet been announced.
Why it is a possibility.
An application already under review, a stated 2026 decision window and reported weight-loss results support the provisional 72% estimate for approval by 31 December.
The FDA can still request more evidence or raise safety, manufacturing or labeling issues. A positive company trial announcement does not substitute for a formal FDA approval.
What could prevent it.
Regulators may request more safety, manufacturing, or labeling evidence, delaying a decision into 2027.
How it will be assessed.
Resolves YES only if the FDA approves CagriSema, the fixed combination of cagrilintide and semaglutide, for chronic weight management in the United States by 31 December 2026. An advisory vote, filing acceptance, or approval for another indication does not count.
Sources and primary records
Probabilities are provisional editorial estimates, not guarantees. Sources document the present evidence and resolution rule. Read the full disclaimer.