Digestive & weight GLP-1 / glucagon dual agonist
Mazdutide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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Key takeaway
Mazdutide is a GLP-1 and glucagon dual-receptor agonist, developed by Innovent Biologics under license from Eli Lilly, given as a once-weekly injection for weight management and type 2 diabetes. In large Phase 3 trials it produced substantial weight loss, and it was approved in China in 2025, while remaining investigational in the United States. As of 2026 it is not FDA-approved.
At a glance
- FDA status
- Approved in China (2025) but investigational and not FDA-approved in the United States
- What it is
- GLP-1 and glucagon receptor dual agonist given as a once-weekly injection
- Research
- Multiple positive Phase 3 trials in Chinese adults with obesity
- Glucagon role
- Intended to add energy expenditure and liver-fat effects
- Evidence strength
- Deep research
Summary
Mazdutide is a once-weekly GLP-1 and glucagon agonist approved in China in 2025. It remains investigational and is not FDA-approved in the U.S.
What is mazdutide?
Mazdutide is a dual-receptor agonist that activates both the GLP-1 receptor and the glucagon receptor in one molecule, based on an analog of the natural hormone oxyntomodulin. It is developed by Innovent Biologics under license from Eli Lilly, with Innovent holding rights in China. It is given as a once-weekly injection for weight management and type 2 diabetes.
How does it work?
Mazdutide combines two hormone actions. The GLP-1 receptor arm:
- Enhances glucose-dependent insulin secretion
- Slows gastric emptying
- Reduces appetite
The glucagon receptor arm is intended to increase energy expenditure and promote breakdown of fat in the liver.
The rationale for adding glucagon action is to boost weight loss and reduce liver fat relative to a GLP-1 drug alone. This describes the proposed mechanism, separate from the outcomes measured in trials.
Is it FDA-approved?
Safety note
Status: Approved in China (2025) but investigational and not FDA-approved in the United States
Category: In clinical trials · Primary body area: Digestive & weight
Not in the United States. Mazdutide is investigational in the U.S. and has not been approved by the FDA. It was approved in China by the NMPA in 2025 for chronic weight management, reported as the first glucagon/GLP-1 dual agonist approved for weight loss, and in September 2025 it was also approved there for type 2 diabetes. Those approvals apply in China and not in the United States.
What does the research show?
Editor’s note
Evidence strength: Deep research
It has multiple positive, replicated Phase 3 trials published in major journals, supporting a national approval in China, though it is not FDA-approved.
The evidence comes from large Phase 3 trials in Chinese adults. According to PubMed, the two GLORY trials reported these weight results:
| Trial | Population | Duration | Weight result |
|---|---|---|---|
| GLORY-1 | Obesity or overweight | 48 weeks | Significant weight reduction versus placebo |
| GLORY-2 | Moderate-to-severe obesity | 60 weeks | Mean weight change of about -17% with mazdutide versus about -2% with placebo |
In GLORY-2, gastrointestinal effects were the most common side effects. A systematic review summarized consistent results across studies in predominantly Chinese populations. These are positive, replicated Phase 3 results underpinning the China approval, though not an FDA approval.
Sources: the GLORY-1 trial (Ji et al., New England Journal of Medicine, 2025, DOI: 10.1056/NEJMoa2411528); the GLORY-2 trial (Gao et al., JAMA, 2026, DOI: 10.1001/jama.2026.8142); and a systematic review (Diabetes, Obesity and Metabolism, 2026, DOI: 10.1111/dom.71058), all indexed on PubMed. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
- [4]
- [5]
- [6]
- ClinicalTrials.gov NCT06124807
- [7]
- [8]
- [9]
- [10]
- [11]
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