Peptide Graded

Cagrilintide

Is Cagrilintide legal in the US?

Not yet; it is still in trials.

BSome human evidenceIn clinical trialsas of 2026-10-27

Cagrilintide is an investigational long-acting amylin analogue from Novo Nordisk and is not approved by the FDA or any other regulator on its own. Novo Nordisk submitted its fixed-dose combination with semaglutide (CagriSema) to the FDA in December 2025, and no FDA decision had been announced by late October 2026. A standalone phase 3 trial of cagrilintide started in November 2025.

No. Neither cagrilintide alone nor CagriSema is approved. Novo Nordisk sent CagriSema to the FDA in December 2025, and no decision had been announced by late October 2026. A standalone phase 3 trial of cagrilintide started in November 2025. 415

Not lawfully. The FDA says drugs still in testing, like cagrilintide, cannot be compounded under federal law. That covers GLP-1 and amylin products. Products sold online under this name have no regulatory oversight. 5

Read the full Cagrilintide page

More on Cagrilintide

Citations

  1. Lau 2021, Lancet: once-weekly cagrilintide for weight management, phase 2 dose-finding trial (DOI) doi.org
  2. StatPearls: Glucagon-like peptide-1 receptor agonists and the incretin system ncbi.nlm.nih.gov
  3. Garvey 2025, NEJM: coadministered cagrilintide and semaglutide (REDEFINE 1) (DOI) doi.org
  4. ClinicalTrials.gov: standalone phase 3 trial of cagrilintide clinicaltrials.gov
  5. FDA: concerns with unapproved GLP-1 drugs used for weight loss fda.gov
  6. DailyMed: Symlin (pramlintide) label dailymed.nlm.nih.gov
  7. Lau 2021, Lancet: once-weekly cagrilintide for weight management, phase 2 trial pubmed.ncbi.nlm.nih.gov
  8. Garvey 2025, NEJM: coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1) pubmed.ncbi.nlm.nih.gov
  9. Wilding 2021, NEJM: once-weekly semaglutide in adults with overweight or obesity (STEP 1) pubmed.ncbi.nlm.nih.gov
  10. Jastreboff 2022, NEJM: tirzepatide once weekly for the treatment of obesity (SURMOUNT-1) pubmed.ncbi.nlm.nih.gov
  11. Enebo 2021, Lancet: cagrilintide with semaglutide, phase 1b trial pubmed.ncbi.nlm.nih.gov
  12. Lancet 2025: amycretin, a unimolecular GLP-1 and amylin receptor agonist, phase 1b/2a pubmed.ncbi.nlm.nih.gov
  13. Diabetes Obes Metab 2024: cagrilintide thorough QT study pubmed.ncbi.nlm.nih.gov
  14. Lancet 2025: eloralintide, a selective amylin receptor agonist, phase 2 trial pubmed.ncbi.nlm.nih.gov
  15. Novo Nordisk Q4 2025 report (SEC filing): CagriSema submitted to the FDA sec.gov
  16. Kow 2026, Diabetes Obes Metab: efficacy and safety of CagriSema in type 2 diabetes, systematic review and Bayesian meta-analysis pubmed.ncbi.nlm.nih.gov

Reference information only, not medical advice. Drawn from the Cagrilintide article, fact-checked against the cited sources. No dosing anywhere on this site.