What is Cagrilintide?

The short answer

Cagrilintide is a new, long-lasting, lab-made form of a hormone the body makes.

  • What it is

    Amylin mimic that slows eating and stomach emptying.

  • What people look into

    Weight

Get updates on Cagrilintide

What it is

Type
Long-acting amylin analog (peptide)
Also known as
cagri, cagrilintide peptide
How it works
Amylin mimic that slows eating and stomach emptying.

Regulatory status

Investigational (phase 3) How we label status

As of October 4, 2026, Cagrilintide is not FDA-approved for any use and is not on FDA's 503A bulks list. It is in phase 3 trials.

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Federal (FDA)
Investigational, not filed as monotherapy
503A compounding
Not eligible (FDA: 'cannot be used in compounding under federal law') (as of October 1, 2026)

US enforcement actions

5 US enforcement actions since 2024.

Actions by US federal and state agencies whose documents name Cagrilintide. Each row links to the government's own document.

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US enforcement actions table
DateAgencyActionDocument
US Justice DepartmentIndictmentJustice Department document, indictment, April 1, 2026, on justice.gov
FDAWarning letterFDA document, warning letter, March 31, 2026, on fda.gov
FDAWarning letterFDA document, warning letter, December 8, 2025, on fda.gov
FDAWarning letterFDA document, warning letter, December 10, 2024, 1 of 2 that day, on fda.gov
FDAWarning letterFDA document, warning letter, December 10, 2024, 2 of 2 that day, on fda.gov

References

Sources as of October 4, 2026

  1. FDA: www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
  2. FDA: api.fda.gov/drug/drugsfda.json
  3. FDA warning letter, December 8, 2025
  4. ClinicalTrials.gov: clinicaltrials.gov/study/NCT06065540
  5. ClinicalTrials.gov: clinicaltrials.gov/study/NCT07220642