Mazdutide: Regulatory Status
Current legal and regulatory status for Mazdutide across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Mazdutide overviewUnited States
Research Only
Compounding status: not available. WADA: prohibited (S4 — hormones and metabolic modulators; GLP-1 class). Phase 3 trials in China for T2DM and obesity (GLORY trial series). As of early 2026, NDA not yet submitted in China. Phase 2 data presented at major conferences (ADA, EASD). No regulatory approvals in any jurisdiction.
What This Means
Reclassification is not the same as FDA approval.
Even if Mazdutide moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.