Mazdutide
IBI362, LY3305677
REC PPT-MAZDUTIDE // REV 2026-10-04 // assessment changes are logged, never silent
A glucagon/GLP-1 dual receptor agonist approved in China by the NMPA for weight management and for type 2 diabetes — a Chinese approval, not a US FDA one; it has no US or EU marketing authorisation.
What it is
Mazdutide (IBI362, LY3305677) is a synthetic analogue of mammalian oxyntomodulin that activates both the GLP-1 receptor and the glucagon receptor. It was licensed from Eli Lilly and developed for the Chinese market by Innovent Biologics.
What it does
Approved and studied for chronic weight management in adults with obesity or overweight, and for glycaemic control in adults with type 2 diabetes. Trials in obstructive sleep apnoea, MASH, hypertension and adolescent obesity are ongoing.
Does it work?
Evidence measured 2026-08-25: 213 indexed publications, 12 randomised controlled trials and 39 interventional ClinicalTrials.gov records, with no meaningful query collision. Nine of those registry records are phase 3. The pivotal GLORY-1 phase 3 trial in Chinese adults with overweight or obesity was published in the New England Journal of Medicine in June 2025; the sponsor reported mean body-weight change at week 48 of -12.0% at 4 mg and -14.8% at 6 mg versus -0.5% on placebo. Almost the entire evidence base was generated in Chinese populations, which is a real limit on how far the findings generalise, and no regulator outside China has been confirmed to have reviewed it.
Claims vs data
Each marketing claim, tagged by what the evidence actually supports.
| Approved by China's NMPA for chronic weight management in adults | supported |
| Produced roughly 15% mean body-weight reduction at the higher dose in a phase 3 trial | supported |
| Outperforms semaglutide for weight loss | weak evidence |
| FDA approved in the United States | overreach |
Reference figures
Quoted from published reference material. These are not Peptuity recommendations.
molecular data — PubChem CID 167312357
The evidence, counted
Live counts from Europe PMC and ClinicalTrials.gov.
248 publications indexed, but only 13 randomised controlled trials and 44 registered interventional studies. Human evidence exists but is thin.
SRC // EUROPE PMC + CTGOV // "Mazdutide" // FETCHED 2026-10-04 // 248 RECORDS
Most-cited literature
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[01]
Comparative effectiveness of GLP-1 receptor agonists on glycaemic control, body weight, and lipid profile for type 2 diabetes: systematic review and network meta-analysis
Yao H, Zhang A, Li D, Wu Y, Wang CZ, Wan JY, Yuan CS. · BMJ 2024 · 449 citations · DOI 10.1136/bmj-2023-076410
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[02]
What is the pipeline for future medications for obesity?
Melson E, Ashraf U, Papamargaritis D, Davies MJ. · Int J Obes (Lond) 2025 · 214 citations · DOI 10.1038/s41366-024-01473-y
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[03]
GLP-1 single, dual, and triple receptor agonists for treating type 2 diabetes and obesity: a narrative review
Alfaris N, Waldrop S, Johnson V, Boaventura B, Kendrick K, Stanford FC · EClinicalMedicine 2024 · 127 citations · DOI 10.1016/j.eclinm.2024.102782
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[04]
The Pharmaceutical Industry in 2023: An Analysis of FDA Drug Approvals from the Perspective of Molecules
de la Torre BG, Albericio F. · Molecules 2024 · 99 citations · DOI 10.3390/molecules29030585
Regulatory status
Formal, dated regulatory actions.
China NMPA (National Medical Products Administration) 2025-06
Approved 27 June 2025 for chronic weight management in adults with a BMI of 28 kg/m2 or above, or 24 kg/m2 or above with at least one weight-related comorbidity, at 4 mg and 6 mg, on the basis of the GLORY-1 phase 3 trial. This is a Chinese NMPA approval and NOT a US FDA approval; mazdutide holds no United States or European Union marketing authorisation.
China NMPA (National Medical Products Administration) 2025-09
Second approval, 19 September 2025, for glycaemic control in adults with type 2 diabetes as monotherapy or combination therapy at 4 mg and 6 mg, on the basis of the DREAMS-1 and DREAMS-2 phase 3 trials. Again a Chinese approval only, not a US FDA approval.
Common questions
Is mazdutide FDA approved?
No. Its approvals are Chinese. China's National Medical Products Administration approved it on 27 June 2025 for chronic weight management and on 19 September 2025 for glycaemic control in type 2 diabetes. No US FDA or EMA marketing authorisation has been confirmed.
What indication and doses did the NMPA approve?
For weight management: adults with a body mass index of 28 kg/m2 or above, or 24 kg/m2 or above with at least one weight-related comorbidity, at 4 mg and 6 mg. A separate approval covers glycaemic control in adults with type 2 diabetes, as monotherapy or in combination, at the same two strengths.
Does the Chinese approval mean it is available or lawful elsewhere?
No. A marketing authorisation is jurisdiction-specific. An NMPA approval carries no legal or regulatory status in Saudi Arabia, the United States, the European Union or anywhere else, and it does not imply that any other regulator has reviewed the same dossier.
How much of the evidence is outside Chinese populations?
Very little. The phase 3 programme that supported approval was run in China, and the early phase 1 work under the Lilly code LY3305677 was small. Response to incretin drugs can differ by baseline body mass index and body composition, so extrapolation beyond the studied populations is an assumption, not a finding.
Related compounds
Semaglutide
GLP-1 agonist. Approved, trial-backed, and genuinely effective for weight and glycaemic control.
Tirzepatide
Dual GIP/GLP-1 agonist. Approved, and outperformed semaglutide in head-to-head trials.
Retatrutide
Triple agonist with the strongest phase 2 weight results yet — but not approved anywhere.
Survodutide
A glucagon/GLP-1 dual receptor agonist with a genuine late-stage randomised programme in obesity and MASH, and no marketing authorisation from any regulator as of August 2026.