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Mazdutide regulatory status

Current status of Mazdutide in the United States: Not eligible for compounding. In sport: WADA status unclear. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Mazdutide?

Regulatory: Not eligible for compoundingWADA: WADA status unclearVerified: Verified Sep 27, 2026
FDA and compounding
Not FDA approved as of the last verification date. Because mazdutide is not a component of an FDA approved drug, has no USP monograph, and is not on the 503A bulks list, it cannot lawfully be compounded or dispensed in the United States, and any product sold as mazdutide in the US is an unapproved drug. Its development and registration have centered on China, where the national drug regulator approved it for chronic weight management in adults (June 2025) and for type 2 diabetes (September 2025); those approvals do not make it legal to sell or compound in the US.
WADA
WADA status unclear
Access path
  1. No lawful United States access path identified on the last verified date outside a registered clinical trial.
  2. Not available as an FDA approved product in the United States and not eligible for compounding under section 503A or 503B while investigational.
  3. Products labeled research use only are not lawful for human use and are not verified for identity or purity.

Full Mazdutide page: evidence, dosing in the literature, and sources

How has the status of Mazdutide changed over time?

No dated regulatory event has been recorded for Mazdutide. That usually means no FDA, PCAC, Federal Register, or WADA action has named it specifically. Category-wide actions are listed on the tracker hub.

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Mazdutide and the source of each dated event.

  1. [1]FDA: concerns with unapproved GLP-1 drugs used for weight lossFDA, 2025
  2. [2]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
  3. [3]WADA Prohibited List, section S0 non-approved substancesWADA, 2026