What is Mazdutide?
The short answer
Mazdutide is a lab-made peptide that copies two hormones, tested so far mostly outside the US.
What it is
Activates GLP-1 and glucagon receptors.
What people look into
Weight
- 4 sources
- Status as of
- How we source
- Ellum doesn't sell peptides.
Get updates on Mazdutide
What it is
- Type
- GLP-1/glucagon dual agonist (peptide)
- Also known as
- ibi362, ly3305677
- How it works
- Activates GLP-1 and glucagon receptors.
Regulatory status
Not FDA-approved How we label status
As of October 4, 2026, Mazdutide is not FDA-approved for any use and is not on FDA's 503A bulks list.
- Federal (FDA)
- Not FDA-approved; no US phase 3 or filing (China trials)
- 503A compounding
- No category; not on 216.23 as of 2026-10-07; not an approved-drug component (as of October 7, 2026)
US enforcement actions
4 US enforcement actions since 2024.
Actions by US federal and state agencies whose documents name Mazdutide. Each row links to the government's own document.
Scroll sideways to see all columns.
US enforcement actions table
| Date | Agency | Action | Document |
|---|---|---|---|
| FDA | Warning letter | FDA document, warning letter, August 24, 2026, on fda.gov | |
| FDA | Warning letter | FDA document, warning letter, March 31, 2026, on fda.gov | |
| FDA | Warning letter | FDA document, warning letter, December 10, 2024, 1 of 2 that day, on fda.gov | |
| FDA | Warning letter | FDA document, warning letter, December 10, 2024, 2 of 2 that day, on fda.gov |
References
Sources as of October 4, 2026