Mazdutide approval status: approved in China, not FDA approved.
Also searched as IBI362 · LY3305677 · GLP-1/glucagon dual agonist
Mazdutide is a once-weekly peptide medicine developed by Innovent in China from a molecule licensed from Eli Lilly. It activates the GLP-1 and glucagon receptors. China approved mazdutide for chronic weight management in June 2025 and for glycemic control in adults with type 2 diabetes in September 2025. Those approvals are jurisdiction-specific: mazdutide is not FDA approved, and a China approval does not authenticate online products or establish access elsewhere.
Where is Mazdutide approved?
Mazdutide has two indication-specific approvals in China: chronic weight management and glycemic control in adults with type 2 diabetes. A separate 9 mg application remains under NMPA review and is not an approval. Mazdutide is not FDA approved, and the China records do not establish US access or seller authority.
Compare Mazdutide with Retatrutide, without losing the country context.
Put evidence status, ClinicalTrials.gov coverage, official United States records, and qualified US research prices in one view. Blank fields stay blank when the underlying dataset does not support a number.
China-approved medicine and active clinical program
Official product and seller records attached
Investigational clinical program
Four records. Three different regulatory outcomes.
Approved indication, application under review, and FDA enforcement are not interchangeable. Each card opens the record that supports the exact claim.
What can you conclude about Mazdutide today?
These are dated program facts, not a cross-trial ranking, approval forecast, personal treatment recommendation, or proof that a same-name online product is the sponsor's medicine.
NMPA approval for chronic weight management came first, followed by glycemic control in adults with type 2 diabetes.
Mean change for the 6 mg group versus 0.30% with placebo in the China Phase 3 obesity trial.
Mean change for the 9 mg group versus 1.50% with placebo in Chinese adults with moderate to severe obesity.
An FDA substance identity record or an online listing is not an approved US drug application or supply route.
Know which molecule the result belongs to.
- Sponsor
- Innovent Biologics; licensed from Eli Lilly for China
- Mechanism
- GLP-1 and glucagon receptor dual agonist
- Route being studied
- Once-weekly subcutaneous injection
- Current stage
- China approvals active; Phase 3 and indication-expansion studies continue
- Featured trial anchors
- NCT05607680 · NCT06164873 · NCT06184568 · NCT05606913
- Evidence checked
- July 22, 2026
Mazdutide weight-loss results, with the trial attached.
These observations came from separate trials or formulations. Each percentage remains attached to its own duration, population, comparator, analysis method, and source.
Evidence checked July 21, 2026Mazdutide reported 14.01% mean reduction at 48 weeks under the peer-reviewed trial mean. The comparator recorded 0.3% mean gain.
Bar lengths share a 0 to 30% visual scale. They describe this selected record and do not make separate trials head-to-head.
- Population
- Chinese adults with obesity or overweight
- Participants
- 610 Total randomized trial population
- Dose
- 6 mg
- Primary analysis
- Peer-reviewed trial mean
- Regulatory status
- Approved in China for chronic weight management; not FDA approved
Mazdutide reported 16.65% mean reduction at 60 weeks under the peer-reviewed analysis of participants receiving at least one dose. The comparator recorded 1.5% mean reduction.
Bar lengths share a 0 to 30% visual scale. They describe this selected record and do not make separate trials head-to-head.
- Population
- Chinese adults with moderate to severe obesity, with or without type 2 diabetes
- Participants
- 461 Participants receiving at least one dose; the registry records 462 randomized participants
- Dose
- 9 mg
- Primary analysis
- Peer-reviewed analysis of participants receiving at least one dose
- Regulatory status
- 9 mg application under NMPA review in China; not FDA approved
Mazdutide clinical trials by status, phase, and location.
The current exact-intervention snapshot matches 37 unique NCT records. This chart describes registry coverage and current study fields. It does not compare efficacy, safety, approval probability, eligibility, or treatment access.
Snapshot 2026-07-24Counts use individual locations currently marked Recruiting, not every facility listed on an overall-recruiting study. Repeated centers across studies remain repeated site observations.
Mazdutide vs Retatrutide: what can actually be compared?
Compare receptor mechanism, sponsor, development stage, approval geography, and trial evidence without treating results from separate populations and protocols as a head-to-head winner.
Open the Mazdutide vs Retatrutide comparison →Mazdutide across 42 countries.
This profile establishes the program identity and its cited clinical or regulatory record. It does not turn a same-name seller listing into the sponsor’s asset or prove authorization, availability, or lawful supply in another destination.
Compare Mazdutide by country →Compare Mazdutide by US state →Browse the global peptide country dataset →Is Mazdutide approved or available in your country?
Start with the United States FDA record, then check the destination that matters to you. Each country page separates drug identity, authorization, product records, seller claims, and supply rules. Directory checked July 20, 2026.
What the record shows - and what it doesn’t.
Trial percentages are kept beside the design details that make them interpretable. Unknowns stay visible instead of being filled with launch speculation.
China has two indication-specific approvals
Innovent announced that China's National Medical Products Administration approved mazdutide for chronic weight management in adults with overweight or obesity on June 27, 2025. A separate approval for glycemic control in adults with type 2 diabetes followed on September 19, 2025. These milestones establish Chinese approvals, not worldwide authorization or seller verification.
GLORY-1 supports the approved weight-management record
GLORY-1 randomized 610 Chinese adults to once-weekly 4 mg mazdutide, 6 mg mazdutide, or placebo for 48 weeks. The peer-reviewed report found mean weight changes of 11.00%, 14.01%, and a 0.30% gain, respectively, at week 48. At least 15% weight reduction was recorded for 35.7%, 49.5%, and 2.0% of participants, respectively.
The 9 mg GLORY-2 result is not the same as a 9 mg approval
GLORY-2 studied once-weekly 9 mg mazdutide for 60 weeks in Chinese adults with moderate to severe obesity. The report found a mean 16.65% reduction versus 1.50% with placebo and described gastrointestinal adverse reactions. Innovent's June 2026 update still described approval and launch of 9 mg as future events, so the trial result must not be presented as an approved 9 mg label.
The FDA has directly treated a US seller's Mazdutide listing as unapproved
In a March 31, 2026 warning letter, the FDA identified one seller's Mazdutide product as an unapproved new drug offered for sale in the United States. This is direct evidence about that seller and US approval status. It does not authenticate other listings or create a universal quality finding about every same-name product.
No FDA-approved mazdutide product
Mazdutide has no FDA-approved indication, prescribing information, US brand, pharmacy channel, coverage policy, or approved US dose. A US substance identity or seller listing does not replace a Drugs@FDA approval record.
The 9 mg regulatory outcome remains separate
A completed Phase 3 result and an accepted application are regulatory milestones, not approval. The approved Chinese presentations and indications must be read from current NMPA records, while any 9 mg decision needs its own dated authority or sponsor confirmation.
Cross-country use and comparative position are unresolved
The cited pivotal studies enrolled Chinese populations and do not establish authorization, market supply, insurance coverage, or comparative effectiveness in the United States, Europe, Mexico, Canada, Australia, or another destination. Those questions require local records and appropriately designed comparisons.
The questions behind the search.
Concise answers based on the dated sponsor and trial records below. This is educational reporting, not medical advice.
What is mazdutide, and is it the same as IBI362 or LY3305677?
Yes. Mazdutide is the international nonproprietary name for the peptide also identified as IBI362 and LY3305677. It is an acylated, long-acting analogue of mammalian oxyntomodulin designed to activate both the GLP-1 and glucagon receptors with once-weekly subcutaneous administration. Innovent licensed the molecule from Eli Lilly for development and commercialization in China. Matching these names resolves the clinical and regulatory evidence trail; it does not prove that an online vial is sponsor material or an authorized medicine in the buyer's country.
Is mazdutide approved, and where is it available?
Mazdutide has indication-specific approvals in China. The NMPA approved it for chronic weight management in adults with overweight or obesity in June 2025, then for glycemic control in adults with type 2 diabetes in September 2025. It is not FDA approved. A Chinese approval cannot be transferred to another country, and it does not prove that a particular pharmacy, clinic, importer, marketplace listing, or research-labelled product is authorized. The exact local product, presentation, seller, and supply route still need to match current official records.
How do the GLORY-1 and GLORY-2 mazdutide results differ?
GLORY-1 tested 4 mg and 6 mg mazdutide against placebo for 48 weeks in Chinese adults with overweight or obesity and supports the original weight-management approval record. GLORY-2 tested 9 mg against placebo for 60 weeks in Chinese adults with moderate to severe obesity and reported a larger mean change alongside substantial gastrointestinal event rates. They used different populations, doses, durations, and protocols. The 9 mg trial result is not permission to use a trial dose, proof of a 9 mg approval, or a fair head-to-head comparison with retatrutide, survodutide, tirzepatide, or semaglutide.
Can you buy mazdutide in the United States?
There is no FDA-approved mazdutide medicine, US prescribing label, legitimate pharmacy channel, manufacturer list price, or routine prescription route. China-specific approvals do not authorize a product in the United States. A website using the names mazdutide, IBI362, or LY3305677 does not prove sponsor identity, FDA approval, lawful import, or pharmacy availability. Use the United States status guide to check the exact FDA, product, seller, and supply records instead of treating a same-name listing as the clinical medicine.
Mazdutide’s NMPA approvals apply to specific products and indications in China. They do not establish FDA approval or authenticate an online product, seller, or supply route in any country.
Understand the product-category boundary →