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China approval plus published human RCT
Mazdutide is an investigational once-weekly injectable studied for weight management — approved in China but not by the FDA or by UK or EU regulators; this page explains what it is, where its approval stands, and general safety considerations, while the dosage calculator handles reconstitution math.
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Mazdutide: reference record
| Regulatory status | Approved in China for chronic weight management; not FDA/UK/EU approved |
|---|---|
| Route | Subcutaneous |
| Dosing frequency | Once weekly |
| Published range | 1.5–6 mg |
| Evidence basis | China approval plus published human RCT |
| Common vial sizes | 6, 10 |
Sources
- PubMed Central - PMC10719339Basis for the regulatory status, route, frequency and published range in the table above. Source last checked 2026-06-24
What is Mazdutide?
Mazdutide is an injectable peptide acting as a dual GLP-1 and glucagon receptor agonist, studied for weight management. Its regulatory position is unusual: it is approved in one jurisdiction but not in the United States, United Kingdom or European Union.
Is Mazdutide FDA-approved?
Not by the FDA. Mazdutide is approved in China for chronic weight management, and there is published Phase 2 human trial data, but it holds no FDA, UK or EU marketing approval.
How is Mazdutide given?
Subcutaneously, once weekly, in the published trials and under the Chinese approval. Escalation in the trials was controlled by protocol.
What are the known safety concerns with Mazdutide?
Approval in one country does not establish approval, lawful supply, or product quality anywhere else. Material obtained outside that approved supply chain carries no assurance of identity or purity.
Phase 2 groups: 1.5->3 mg; 1.5->3->4.5 mg; or 2->4->6 mg, with 4-week steps
Uses the published Phase 2 schedule because non-Chinese users may not have access to the approved local label.
Approval in China does not establish approval, lawful supply, or product quality elsewhere.
Supply-chain quality · Finnrick
Avg quality score
6.7
/10
Purity range
95.94
–
99.85
%
Qty divergence
±
78
%
Vendors · samples
10
·
28
Common vial sizes
6, 10
mg
Test window
Apr 2025 - Apr 2026
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