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Research → decisions → accessEvidence checked 13 Sep 2026
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A clearer view of the milestones shaping peptide and GLP-1 medicines in the UK, US and EU: confirmed decisions, company targets and clearly labelled estimates, each with its source. What we track · How estimates are made.
CagriSema
Novo Nordisk · Amylin analogue plus GLP-1 receptor agonist (combination) · Peptide combination · Under regulatory review
Confirmed eventCompany targetRegulator targetEditorial estimateTiming unknown or undatedSafety update
Dashed line: today, 13 Sep 2026. Future windows are conditional. Approval, launch and funded access are separate milestones.
Confirmed · December 2025United States
Novo Nordisk reports CagriSema submitted to FDA
Novo Nordisk's 2025 annual report states that CagriSema was submitted to the FDA in December 2025 for weight management.
Why it matters. A submission is not an approval. The latest disposition (acceptance, review timetable, decision) is being verified before any present-day status or forecast is shown.
Event
Submission made
Indication
Chronic weight management (Obesity, or overweight with at least one weight-related condition, alongside diet and physical activity)
Product
CagriSema (cagrilintide and semaglutide), once-weekly injection
All CagriSema (cagrilintide and semaglutide) records (accessible list)
CagriSema (cagrilintide and semaglutide)
Fixed-dose combination of cagrilintide and semaglutide for weight management; submitted to FDA according to the sponsor.
United Kingdom
No verified events recorded yet. Regulator: MHRA.
United States
December 2025 · Submission made Confirmed
Novo Nordisk reports CagriSema submitted to FDA
Chronic weight management
Novo Nordisk's 2025 annual report states that CagriSema was submitted to the FDA in December 2025 for weight management.
Why it matters: A submission is not an approval. The latest disposition (acceptance, review timetable, decision) is being verified before any present-day status or forecast is shown.
No verified events recorded yet. Regulator: EMA / European Commission.
This list is the complete, accessible view of the tracker; the board above draws from exactly the same records. Every entry is labelled Confirmed (official record), Company target (a dated sponsor statement), Regulator target (an official decision date, not a guarantee), GLPInfo estimate (an editorial range with assumptions) or Timing unknown. An approval is never inferred from a target date passing.