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Legal status by country

Is BGM0504 legal?

Written by Reviewed Sep 2026

MetabolicHuman studies cited: 2

How BGM0504 is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.

All four countries, side by side

AttributeUnited States · FDAUnited Kingdom · MHRAAustralia · TGACanada · Health Canada
StatusNot approvedNot approvedNot approvedNot approved
ClassificationInvestigational, not approvedInvestigational, not licensedInvestigational, not registeredInvestigational, not approved
NoteNo approval and no registered United States trial located. The clinical programme is in China and Indonesia.No MHRA filing located.None recordedNone recorded

US FDA status: Not approved anywhere. Multiple phase 3 trials are recruiting in China and Indonesia, and a tablet formulation is in phase 1. The phase 3 obesity result announced in May 2026 has not been published in a peer-reviewed journal as of this review.. Reviewed Sep 2026.

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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.