Mazdutide
Glucagon and GLP-1 receptor dual agonist (oxyntomodulin analog)
Status
Approved elsewhere
Approved in China by the NMPA for chronic weight management (June 2025) and type 2 diabetes (September 2025), marketed by Innovent Biologics under license from Eli Lilly; it is not approved by the FDA or EMA.
Evidence
Strong
Several large phase 3 randomized trials (GLORY-1, DREAMS-1, DREAMS-2) support its approved uses, though all enrolled Chinese adults.
Mazdutide is a once-weekly injected peptide, modeled on the gut hormone oxyntomodulin, that activates both glucagon and GLP-1 receptors. It was first approved in China in 2025 for chronic weight management and type 2 diabetes, but is not approved in the US or EU.
Structure
34 residues- aK20C20 fatty diacid via γGlu-2xOEG linker (albumin binding)
Point at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.
Sequence as text
H-H-Aib-Q-G-T-F-T-S-D-Y-S-K-Y-L-D-E-K-K-A-K-E-F-V-E-W-L-L-E-G-G-P-S-S-G-NH2
What it is used for
- Chronic weight management in adults, China (approved)
- Type 2 diabetes, glycemic control, China (approved)
- Fatty liver disease, obstructive sleep apnea and alcohol use disorder (studied)
How it works
Mazdutide is an oxyntomodulin analog: like that natural gut hormone it activates both GLP-1 and glucagon receptors. GLP-1 activity reduces appetite and improves blood glucose control, while glucagon activity, as with oxyntomodulin, is thought to raise energy expenditure; in GLORY-1 mazdutide also cut liver fat. An Aib residue at position 2 resists enzymatic breakdown, and a C20 fatty diacid on Lys20 binds albumin for weekly dosing.
How strong the evidence is
Strong
GLORY-1 (NEJM 2025; 610 Chinese adults with overweight or obesity) found mean weight changes at 48 weeks of -11.0% (4 mg) and -14.0% (6 mg) versus +0.3% with placebo, with discontinuation for adverse events of 0.5% to 1.5%. In type 2 diabetes, DREAMS-2 (731 participants, Nature 2026) found both doses lowered HbA1c and weight more than dulaglutide 1.5 mg at 28 weeks, and DREAMS-1 showed benefit versus placebo. All phase 3 trials so far enrolled Chinese adults.
Risks and side effects
- Diarrhea, nausea and vomiting are the most common side effects, mostly mild to moderate
- Long-term safety and outcome data outside China are limited
- Not approved in the US or EU; products sold there as research peptides are unregulated, with unknown identity and purity
Regulatory status
| Region | Year | Approved for |
|---|---|---|
| CNNMPA | 2025 | Chronic weight management in adults with BMI of 28 or more, or 24 or more with a weight-related condition |
| CNNMPA | 2025 | Glycemic control in adults with type 2 diabetes |
Status by country
| Jurisdiction | Status | Source |
|---|---|---|
| USUnited States | No authorised medicine | Source 10 |
| EUEuropean Union | No authorised medicine | Source 11 |
| UKUnited Kingdom | No authorised medicine | Source 12 |
| AUAustralia | No authorised medicine | Source 13 |
| CACanada | No authorised medicine | Source 14 |
Trials of Mazdutide to watch
Mazdutide in MASH(opens the source in a new tab)
A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Mazdutide in hypertension(opens the source in a new tab)
Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity
Mazdutide in heart failure(opens the source in a new tab)
A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity
GLORY-3(opens the source in a new tab)
A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）
GLORY-OSA(opens the source in a new tab)
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
GLORY-YOUNG(opens the source in a new tab)
A Study of IBI362 in Chinese Adolescents With Obesity or Overweight
Mazdutide in alcohol use disorder(opens the source in a new tab)
A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
DREAMS-3(opens the source in a new tab)
A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity
Timeline
2027
2026
2025
- DREAMS-3
- ApprovalChina approves mazdutide, first dual glucagon and GLP-1 agonist for weight loss
- Approved, CN (NMPA)Chronic weight management in adults with BMI of 28 or more, or 24 or more with a weight-related condition
Show 1 earlier event
2025
- Approved, CN (NMPA)Glycemic control in adults with type 2 diabetes
Sources
- 01International Nonproprietary Names for Pharmaceutical Substances: Proposed INN List 126(opens the source in a new tab)
- 02Mazdutide (D12225): sequence and structure entry(opens the source in a new tab)
- 03Mazdutide: First Approval(opens the source in a new tab)
- 04BI 456906: Discovery and preclinical pharmacology of a novel GCGR/GLP-1R dual agonist (background on oxyntomodulin)(opens the source in a new tab)
- 05Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1)(opens the source in a new tab)
- 06Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes (DREAMS-2)(opens the source in a new tab)
- 07Mazdutide versus placebo in Chinese adults with type 2 diabetes (DREAMS-1)(opens the source in a new tab)
- 08Innovent announces mazdutide received approval from China's NMPA for chronic weight management(opens the source in a new tab)
- 09Innovent announces mazdutide received approval from China's NMPA for glycemic control in adults with type 2 diabetes(opens the source in a new tab)
- 10FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss(opens the source in a new tab)
- 11Find medicine: centrally authorised medicines(opens the source in a new tab)
- 12MHRA Products: active substances beginning with M(opens the source in a new tab)
- 13Australian Register of Therapeutic Goods (ARTG)(opens the source in a new tab)
- 14Drug Product Database online query(opens the source in a new tab)
Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.