News
CagriSema was submitted to the FDA in December 2025. A submission is not an approval
Novo Nordisk's 2025 annual report states that CagriSema, its cagrilintide and semaglutide combination, was submitted to the FDA in December 2025 for weight management. GLPInfo records this as a submission event and is verifying the latest disposition before showing any status or forecast.
Novo Nordisk states in its 2025 annual report that CagriSema was submitted to the US Food and Drug Administration in December 2025.
Source: Annual Report 2025: innovation and therapeutic focus (February 2026)
CagriSema is a fixed-dose combination of cagrilintide, an amylin analogue, and semaglutide, a GLP-1 receptor agonist, given as a once-weekly injection.
Source: Annual Report 2025: innovation and therapeutic focus (February 2026)
A submission starts a regulatory process; it is not an acceptance, a review target date or an approval. GLPInfo shows it as a dated submission event and will add the filing acceptance, any regulator target date and the decision as each is confirmed by an official record.
Source: Annual Report 2025: innovation and therapeutic focus (February 2026)
Why it matters
Combination medicines that pair an amylin analogue with a GLP-1 agonist are one of the main directions the field is moving in. Recording the submission accurately, and refusing to guess at the decision, is exactly what the tracker is for.
What remains uncertain
- Whether the application has been accepted for review and any target action date have not yet been verified from an official record.
- UK and EU filings are not yet recorded.
On the timeline
- United States: Novo Nordisk reports CagriSema submitted to FDA (December 2025)
About this article. Written by the GLPInfo editorial team with AI assistance from the official sources linked on the page, and approved by the site owner before publication. It has not yet been reviewed by a named clinician. Published 13 Sep 2026. Information, not medical advice: decisions about any medicine sit with you and a qualified prescriber. Spotted an error? Report a correction.