Is CagriSema FDA Approved Yet?
No. CagriSema is not FDA approved as of September 25, 2026. Novo Nordisk has applied for approval for weight management, but the combination remains investigational while the FDA reviews it.
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What has happened so far?
- December 18, 2025: Novo Nordisk announced that it had submitted a New Drug Application for once-weekly CagriSema for weight management in adults with obesity or overweight with at least one weight-related condition.
- September 21, 2026: Novo released more phase 3 trial results, still called CagriSema investigational, and said it expected an FDA decision in the fourth quarter of 2026.
- Today: There is no announced FDA approval. A submitted application and positive study results do not authorize routine prescribing of the new combination.
What to watch:An FDA decision and, if approved, the agency's approved label. Novo's quarterly forecast can change, and approval is not guaranteed.
What exactly is under review?
CagriSema combines cagrilintide, an amylin analogue, with semaglutide, a GLP-1 receptor agonist, in a once-weekly injection. Novo's December 2025 application concerns the fixed-dose combination for weight management. The FDA must evaluate the application and proposed label before that combination could be marketed for that use.
The September trial headlines do not change its approval status. One new study compared particular doses in adults with type 2 diabetes; it cannot establish that CagriSema is better than every dose of tirzepatide for every patient. More importantly for this question, trial findings are not an FDA approval decision.
For a wider view of approved and investigational medicines, see our FDA-approved peptides guide and GLP-1 medication comparison.
Common questions
Is CagriSema FDA approved in the United States?
No. As of September 25, 2026, CagriSema remains investigational. Novo Nordisk filed a New Drug Application for weight management in December 2025, but filing an application is not an FDA approval.
When might the FDA decide on CagriSema?
Novo Nordisk said on September 21, 2026 that it expected an FDA decision in the fourth quarter of 2026. That is a company forecast, not a confirmed FDA decision date or a promise of approval.
What is in CagriSema?
CagriSema is an investigational, once-weekly injectable combination of cagrilintide, an amylin analogue, and semaglutide, a GLP-1 receptor agonist. Approval of a component does not approve the combination.
Do new weight-loss trial results mean CagriSema is approved?
No. Trial results are evidence the FDA may review, not an approval announcement. Novo Nordisk still described CagriSema as investigational when it reported new phase 3 results in September 2026.
Can LiveNow prescribe CagriSema now?
No. LiveNow does not offer CagriSema as a treatment. For current weight-management options, a clinician can evaluate your history and discuss appropriate approved treatments; an evaluation does not guarantee a prescription.
Public sources checked September 25, 2026. This page is educational information and does not provide individual medical advice.
Check the primary sources
FDA explains how to confirm an approval. Novo's dated releases document the application, investigational status and expected decision window.