Ecnoglutide: Regulatory Status
Current legal and regulatory status for Ecnoglutide across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Ecnoglutide overviewUnited States
Research Only
Compounding status: not available. WADA: prohibited (S4 — hormones and metabolic modulators; GLP-1 class). Clinical development primarily in China. Phase 3 trials (GLORY series by Sciwind) in T2DM and obesity underway as of 2025-2026. IND filing or Phase 1 in US/EU not confirmed as of early 2026. No regulatory approvals in any jurisdiction.
What This Means
Reclassification is not the same as FDA approval.
Even if Ecnoglutide 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.