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Cagrilintide

Cagrilintide is an experimental, long-acting version of amylin, a pancreatic hormone that promotes a feeling of fullness. Novo Nordisk is testing it alone and combined with semaglutide (as CagriSema) for weight management and type 2 diabetes. It is not approved anywhere on its own.

In clinical trialsWADA Not named; as an unapproved drug it falls under S0 (prohibited at all times)Checked October 2026
Open the Cagrilintide calculatorSources

Approval status

Not approved anywhere on its own. In September 2025 Novo Nordisk said it would move cagrilintide alone into a dedicated phase 3 program (RENEW). Its combination with semaglutide (CagriSema) was submitted to the FDA in December 2025 and had not been approved as of October 2026.45611

What it’s used or studied for

  • Human studies

    Weight loss on its own in adults with overweight or obesity, in a phase 2 trial and in the cagrilintide-only group of the phase 3 REDEFINE 1 trial.478

  • Human studies

    Weight loss when combined with semaglutide (CagriSema) in adults with overweight or obesity, with or without type 2 diabetes (REDEFINE 1 and REDEFINE 2 trials).89

  • Human studies

    Blood sugar control in type 2 diabetes, tested alone and with semaglutide in the phase 3 REIMAGINE 2 trial.10

Each label shows how strong the evidence is: an approved use, human studies, animal or lab studies only, or a popular claim with no published studies. Being studied is not the same as being proven safe or effective.

Side effects

Common

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Injection site reactions

There is no approved label; these come from trials. Stomach and bowel effects were the most common and mostly mild to moderate. In REDEFINE 1, 1% of people on cagrilintide alone stopped treatment because of nausea.47

Cautions

  • The long-term safety of cagrilintide on its own is still being studied in phase 3 trials.4
  • FDA states that cagrilintide cannot be used in compounding under federal law.12

Sources

  1. PubChem: Cagrilintide (CID 171397054)
  2. FDA Global Substance Registration System (GSRS): Cagrilintide
  3. Kruse T et al. Development of cagrilintide, a long-acting amylin analogue (J Med Chem, 2021)
  4. Novo Nordisk press release: Phase 3 data for next-generation amylin cagrilintide leading to advancement into dedicated clinical programme, 16 September 2025
  5. Novo Nordisk press release: Novo Nordisk files for FDA approval of CagriSema, 18 December 2025
  6. WADA 2026 Prohibited List
  7. Lau DCW et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a phase 2 trial (Lancet, 2021)
  8. Garvey WT et al. Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1) (N Engl J Med, 2025)
  9. Davies MJ et al. Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE 2) (N Engl J Med, 2025)
  10. Buse JB et al. Cagrilintide-semaglutide versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2) (Lancet Diabetes Endocrinol, 2026)
  11. FDA: Novel drug approvals for 2026 (content current as of 20 October 2026)
  12. FDA: FDA's concerns with unapproved GLP-1 drugs used for weight loss (content current as of 1 October 2026)

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