Mazdutide

Grade B: Human evidence, not approved for this use

TL;DR: Mazdutide (IBI362) is a once-weekly injectable dual agonist of the GLP-1 receptor and glucagon receptor (GCGR), developed by Innovent Biologics as an analogue of oxyntomodulin. China's National Medical Products Administration (NMPA) approved mazdutide in June 2025 for chronic weight management in adults (BMI at least 28 kg/m² or at least 24 kg/m² with comorbidities), making it the first GLP-1/glucagon dual agonist to receive full regulatory approval for obesity globally; a subsequent NMPA approval for type 2 diabetes followed. All RCT data supporting these approvals were conducted in Chinese populations; no US or European Phase 3 trials have been completed, and mazdutide is not approved by FDA or EMA as of June 2026. Phase 2 and Phase 3 data from Chinese trials demonstrated clinically significant weight loss alongside reductions in HbA1c, liver fat content, and cardiometabolic markers. Evidence is Grade B due to absence of FDA or EMA approval and lack of data in Western populations.

Key Takeaways

Grade B: Human evidence, not approved for this use
Not FDA approved: Not approved by FDA; approved by China's NMPA in 2025 for obesity and type 2 diabetes; no US regulatory submission publicly announced as of June 2026.
Compounding: Not approved by FDA or EMA as of June 2026; approved only in China by NMPA. Mazdutide is not eligible for compounding in the United States under 503A or 503B provisions as an unapproved foreign-approved substance.

Mazdutide chemical structure — Structure via PubChem CID 167312357

Mechanism

Dual agonism at GLP-1 and glucagon receptors (as an oxyntomodulin analogue) to suppress appetite and food intake via GLP-1 signaling while increasing hepatic fat oxidation and energy expenditure via glucagon receptor activation.

Evidence

Mazdutide (IBI362) is a once-weekly injectable dual agonist of the GLP-1 receptor and glucagon receptor (GCGR), developed by Innovent Biologics as an analogue of oxyntomodulin. China's National Medical Products Administration (NMPA) approved mazdutide in June 2025 for chronic weight management in adults (BMI at least 28 kg/m² or at least 24 kg/m² with comorbidities), making it the first GLP-1/glucagon dual agonist to receive full regulatory approval for obesity globally; a subsequent NMPA approval for type 2 diabetes followed. All RCT data supporting these approvals were conducted in Chinese populations; no US or European Phase 3 trials have been completed, and mazdutide is not approved by FDA or EMA as of June 2026. Phase 2 and Phase 3 data from Chinese trials demonstrated clinically significant weight loss alongside reductions in HbA1c, liver fat content, and cardiometabolic markers. Evidence is Grade B due to absence of FDA or EMA approval and lack of data in Western populations.

Safety and risks

As a GLP-1 receptor agonist component, mazdutide carries the class risk of thyroid C-cell tumors observed with GLP-1 receptor agonists in rodent studies; patients with personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2) are excluded from trials and should not use GLP-1-containing agents. Gastrointestinal adverse events (nausea, vomiting, diarrhea, constipation) are the dominant safety signal, consistent with the GLP-1 class. The glucagon receptor (GCGR) component introduces hepatic metabolic effects distinct from pure GLP-1 agents: glucagon receptor activation increases hepatic glucose output and fat oxidation; monitoring of hepatic metabolic markers is warranted, and the clinical significance of sustained dual-receptor hepatic stimulation in diverse patient populations is not yet fully characterized. All RCT safety data are from Chinese populations only; the safety profile in US or European populations has not been established in Phase 3 trials, and extrapolation should be made with caution given potential differences in baseline comorbidities, concomitant medications, and genetic factors. Standard GLP-1 class precautions apply: acute pancreatitis, gallbladder disease, volume depletion-related acute kidney injury, and pulmonary aspiration risk during anesthesia.

Interactions

No FDA-approved label exists; class-level GLP-1 interactions apply (enhanced hypoglycemia with insulin or secretagogues; delayed gastric emptying affects oral drug absorption). Glucagon receptor activity may alter hepatic glucose regulation and interact with antidiabetic regimens. Confirm interaction profile with prescribing clinician.

Compounding legality

Not approved by FDA or EMA as of June 2026; approved only in China by NMPA. Mazdutide is not eligible for compounding in the United States under 503A or 503B provisions as an unapproved foreign-approved substance.

Sources

Mazdutide is Not FDA approved. PeptideGrids presents evidence and regulatory status for informational purposes only. We do not sell, supply, source, or help anyone obtain this compound, and we provide no dosing or administration guidance. This is not medical advice; consult a licensed clinician. Full disclaimer.

Last reviewed June 1, 2026 by PeptideGrids editorial team (independently audited).