Medicine profile
CagriSema
Fixed-dose combination of cagrilintide and semaglutide for weight management; submitted to FDA according to the sponsor.
- Generic name
- CagriSema (cagrilintide and semaglutide)
- Also known as
- CagriSema, cagrilintide/semaglutide
- Sponsor and licensing
- Novo Nordisk (originator)
- Mechanism
- Amylin analogue plus GLP-1 receptor agonist (combination)
- Molecular type
- Peptide combination (mechanism and molecular type are recorded separately: GLP-1 activity does not make a medicine a peptide)
Brands, routes and formulations
CagriSema (no brand yet)
subcutaneous 路 once-weekly injection
No verified approval recorded for this product.
Regulatory status by jurisdiction
Authorisation, launch and funded access are three different things and are shown separately. "Not recorded" means GLPInfo has not verified an event, not that nothing has happened.
| United States (FDA) | United Kingdom (MHRA) | European Union (EMA / EC) | |
|---|---|---|---|
| Regulatory authorisation | Not recorded | Not recorded | Not recorded |
| Commercial launch | Not recorded | Not recorded | Not recorded |
| Funded access | Not recorded | Not recorded | Not recorded |
Development timeline
CagriSema
Dashed line: today, 13 Sep 2026. Future windows are conditional. Approval, launch and funded access are separate milestones.
Select a marker to open its record in the pipeline view, which has the detail panel and the accessible list.
Next milestone and forecast rationale
No forecast is published for CagriSema. One appears only when there is a responsible range with assumptions and sources.
Trial evidence
| Trial | Phase | Population | Duration | Results |
|---|---|---|---|---|
| REDEFINE 4Novo Nordisk 路 subcutaneous, once weekly | 3 | 809 adults with obesity and at least one obesity-related condition (per workbook) | 84 weeks | On file from the research workbook; withheld until the primary publication or registry record is attached. |
GLPInfo does not rank unrelated trials against each other or quote "weight loss per week": populations, durations and methods differ and weight change is not linear. Results appear here per trial and dose arm, with comparator, endpoint and source, once cited.
Known limitations and official labels
This profile is assembled from the regulatory records and sponsor statements GLPInfo has verified; it is not a complete review of CagriSema. The current official label in each jurisdiction is the authority on indications, populations and safety.
Review date and correction history
Records last checked 13 Sep 2026. No corrections have been made to the records on this profile; every record is at version 1. Report a correction.
Related 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.