mazdutide

Mazdutide is approved in China for chronic weight management and type 2 diabetes, with separate Chinese prescribing documents dated June and September 2025. The approved product comes in 2 mg, 4 mg, and 6 mg strengths with specific contraindications and titration rules; the 9 mg and 16 mg research regimens fall outside those commercial weight-management strengths.

GLP-1 and glucagon receptor dual agonist

Once-weekly GLP-1 and glucagon receptor dual agonist
Approved by China's NMPA according to current developer disclosures
No U.S. FDA approval in the cited records

Where is mazdutide approved today?

China approved mazdutide for chronic weight management in June 2025 and for glycemic control in adults with type 2 diabetes in September 2025. The Chinese weight label covers adults with BMI at least 28, or BMI at least 24 plus at least one weight-related comorbidity. The cited U.S. FDA records list no mazdutide approval.

The Chinese package insert contains separate prescribing documents approved June 24 and September 16, 2025. Both list 2 mg, 4 mg, and 6 mg per 0.5 mL strengths. GLORY-2's 9 mg and the U.S. phase 2 trial's 16 mg regimen are research doses outside those strengths.

Xinermei Chinese label · dosing and safety

Manufacturer-hosted approved Chinese package insert

Innovent Biologics, approved June 24 and September 16, 2025

The Chinese package insert defines the weight-management and type 2 diabetes populations, 2 mg to 6 mg strengths, titration and missed-dose rules, contraindications, warnings, and GLORY-1 adverse-reaction frequencies.

Weight management: BMI at least 28, or at least 24 with a weight-related comorbidity.
Boxed thyroid C-cell tumor warning; contraindicated with MTC history or MEN2.
Stop at least three months before planned pregnancy.

Participants / model: Adults covered by the separate Chinese weight-management and type 2 diabetes indications
Treatment: Mazdutide 2 mg, 4 mg, or 6 mg per 0.5 mL once weekly
Follow-up: Weight label approved June 24, 2025; diabetes label approved September 16, 2025
Study design: Chinese-language prescribing document hosted by the marketing-authorization holder

This Chinese label governs the named product, not higher trial doses, U.S. use, or products of uncertain identity.

Read the original source

NMPA June 2025 · Chinese weight indication

Chinese regulator approval announcement

National Medical Products Administration, June 27, 2025

NMPA announced approval of mazdutide injection for long-term weight management with diet and physical activity in the defined adult BMI populations.

Participants / model: Adults in China with BMI at least 28, or BMI at least 24 plus a weight-related comorbidity
Treatment: Mazdutide injection as an adjunct to diet and increased physical activity
Follow-up: Approval announced June 27, 2025
Study design: Chinese-language regulator announcement

Product guidance comes from the Chinese package insert rather than the NMPA database record.

Read the original source

U.S. FDA · no mazdutide approval

FDA drug records

Drugs@FDA and openFDA records for mazdutide and IBI362.

The cited U.S. FDA databases list no approval record for mazdutide or IBI362.

Participants / model: United States drug approvals
Treatment: Mazdutide and IBI362

Read the original source

Why does GLORY-1 report both 14.01% and 14.84%?

They come from different prespecified estimands. At week 48, the 6 mg arm changed -14.01% versus +0.30% with placebo under the treatment-policy estimand and -14.84% versus -0.47% under the efficacy estimand. Neither number is a transcription error when its analysis condition stays attached.

GLORY-1 week-48 mean body-weight change
Estimand	Mazdutide 6 mg	Placebo
Treatment policy	-14.01%	+0.30%
Efficacy	-14.84%	-0.47%

GLORY-1 · two estimands explained

Randomized trial

New England Journal of Medicine, 2025

The 610-person trial reported both treatment-policy and efficacy estimands, explaining the 14.01% and 14.84% week-48 values.

Participants / model: Chinese adults with BMI at least 28, or 24 to below 28 plus a weight-related condition
Treatment: Weekly mazdutide 4 mg, 6 mg, or placebo
Follow-up: 48 weeks
Study design: Randomized, double-blind phase 3 trial

GLORY-1 studied Chinese adults and the approved Chinese product; it does not establish labeling or applicability in other countries. Chinese registry identifier: CTR20222567. Outcome data come from the published report and Chinese package insert.

Read the original source

What did GLORY-2 show in a higher-BMI population?

Among 461 treated Chinese adults with BMI at least 30, mean week-60 weight change was -16.65% with mazdutide 9 mg versus -1.50% with placebo under the treatment-policy analysis. Vomiting occurred in 53.1%, nausea in 46.9%, and diarrhea in 39.4% with mazdutide.

The sponsor’s 20.1% figure came from a more selective analysis or subgroup. The overall treatment-policy estimate was lower.

GLORY-2 · 60-week phase 3 result

Randomized trial

JAMA, 2026

The trial reported -16.65% versus -1.50% mean weight change under the treatment-policy analysis and high gastrointestinal-event frequencies.

Participants / model: Chinese adults with BMI at least 30; 16.1% had type 2 diabetes
Treatment: Weekly mazdutide 9 mg or placebo
Follow-up: 60 weeks
Study design: Randomized, double-blind phase 3 trial

The overall analysis is not interchangeable with a no-diabetes subgroup or efficacy estimand. Chinese registry identifier: CTR20233902. The registry record is not used as an outcome report.

Read the original source

What evidence now exists in U.S. participants?

A 2026 U.S. phase 2 trial reported 32-week efficacy-estimand weight changes of -7.3%, -15.6%, and -18.1% across three dose regimens versus -0.9% with placebo. At the 16 mg regimen, 20% discontinued because of adverse events, mostly gastrointestinal.

This US phase 2 result does not provide a pivotal safety database or FDA approval.

Mazdutide U.S. phase 2 · efficacy and tolerability

Randomized trial

Diabetes, Obesity and Metabolism, 2026

At 32 weeks, efficacy-estimand weight changes ranged from -7.3% to -18.1% versus -0.9% with placebo; adverse-event discontinuation reached 20% at 16 mg.

Participants / model: U.S. adults with overweight or obesity
Treatment: Three weekly mazdutide titration regimens or placebo
Follow-up: 32 weeks
Study design: Randomized, double-blind phase 2 trial

Short phase 2 follow-up and high-dose discontinuation limit inference about long-term U.S. use.

Read the original source

How common were side effects, and who should not use the Chinese product?

In the GLORY-1 label dataset, nausea occurred in 32.5% with 4 mg, 50.5% with 6 mg, and 5.9% with placebo. Diarrhea occurred in 35.0%, 38.6%, and 6.3%; vomiting in 26.1%, 43.1%, and 2.9%. Overall treatment discontinuation for adverse events was 1.0% with pooled mazdutide and 1.0% with placebo.

Common adverse reactions in the Chinese GLORY-1 weight-management label
Reaction	Mazdutide 4 mg	Mazdutide 6 mg	Placebo
Nausea	32.5%	50.5%	5.9%
Diarrhea	35.0%	38.6%	6.3%
Vomiting	26.1%	43.1%	2.9%
Injection-site reactions	6.9%	8.4%	1.5%
Dizziness	5.4%	7.9%	3.9%
Gastroesophageal reflux disease	4.4%	7.9%	1.0%

The label has a boxed warning for thyroid C-cell tumors observed in rodents, with unknown human relevance. It contraindicates use with a personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2, or hypersensitivity to the product.

Other warnings cover pancreatitis, gallbladder disease, persistent heart-rate increase, dehydration and kidney injury, severe gastrointestinal disease, aspiration risk during anesthesia or deep sedation, hypersensitivity, and monitoring for suicidal thoughts or behavior. GLORY-1 had one mild gallstone-related obstructive pancreatitis case with mazdutide and none with placebo.

Xinermei Chinese label · dosing and safety

Manufacturer-hosted approved Chinese package insert

Innovent Biologics, approved June 24 and September 16, 2025

The Chinese package insert defines the weight-management and type 2 diabetes populations, 2 mg to 6 mg strengths, titration and missed-dose rules, contraindications, warnings, and GLORY-1 adverse-reaction frequencies.

Weight management: BMI at least 28, or at least 24 with a weight-related comorbidity.
Boxed thyroid C-cell tumor warning; contraindicated with MTC history or MEN2.
Stop at least three months before planned pregnancy.

Participants / model: Adults covered by the separate Chinese weight-management and type 2 diabetes indications
Treatment: Mazdutide 2 mg, 4 mg, or 6 mg per 0.5 mL once weekly
Follow-up: Weight label approved June 24, 2025; diabetes label approved September 16, 2025
Study design: Chinese-language prescribing document hosted by the marketing-authorization holder

This Chinese label governs the named product, not higher trial doses, U.S. use, or products of uncertain identity.

Read the original source

GLORY-1 · two estimands explained

Randomized trial

New England Journal of Medicine, 2025

The 610-person trial reported both treatment-policy and efficacy estimands, explaining the 14.01% and 14.84% week-48 values.

Participants / model: Chinese adults with BMI at least 28, or 24 to below 28 plus a weight-related condition
Treatment: Weekly mazdutide 4 mg, 6 mg, or placebo
Follow-up: 48 weeks
Study design: Randomized, double-blind phase 3 trial

GLORY-1 studied Chinese adults and the approved Chinese product; it does not establish labeling or applicability in other countries. Chinese registry identifier: CTR20222567. Outcome data come from the published report and Chinese package insert.

Read the original source

GLORY-2 · 60-week phase 3 result

Randomized trial

JAMA, 2026

The trial reported -16.65% versus -1.50% mean weight change under the treatment-policy analysis and high gastrointestinal-event frequencies.

Participants / model: Chinese adults with BMI at least 30; 16.1% had type 2 diabetes
Treatment: Weekly mazdutide 9 mg or placebo
Follow-up: 60 weeks
Study design: Randomized, double-blind phase 3 trial

The overall analysis is not interchangeable with a no-diabetes subgroup or efficacy estimand. Chinese registry identifier: CTR20233902. The registry record is not used as an outcome report.

Read the original source

Mazdutide U.S. phase 2 · efficacy and tolerability

Randomized trial

Diabetes, Obesity and Metabolism, 2026

At 32 weeks, efficacy-estimand weight changes ranged from -7.3% to -18.1% versus -0.9% with placebo; adverse-event discontinuation reached 20% at 16 mg.

Participants / model: U.S. adults with overweight or obesity
Treatment: Three weekly mazdutide titration regimens or placebo
Follow-up: 32 weeks
Study design: Randomized, double-blind phase 2 trial

Short phase 2 follow-up and high-dose discontinuation limit inference about long-term U.S. use.

Read the original source

What are the Chinese label's titration, missed-dose, and pregnancy rules?

For weight management, the Chinese label starts 2 mg once weekly for four weeks, increases to 4 mg, and permits 6 mg after at least four weeks at the current dose if more effect is needed. Maintenance is 4 mg or 6 mg weekly, and a patient unable to tolerate 6 mg can return to 4 mg.

Missed by no more than 2 days: take it promptly and keep the original weekly day.
Missed by 2 to 7 days: take it promptly and make that the new weekly day.
Missed by 7 to 21 days: step down one titration level.
Missed by more than 21 days: restart at 2 mg and retitrate.

The weekly injection day may be changed if doses remain more than 120 hours apart. Delayed gastric emptying may alter absorption of oral medicines, so the label calls for caution and closer monitoring of threshold-dependent or narrow-therapeutic-index drugs such as warfarin.

The label contraindicates use during pregnancy and breastfeeding and says to stop at least three months before a planned pregnancy. Safety and effectiveness under age 18 are not established, and only three adults age 65 or older entered the weight trial.

Xinermei Chinese label · dosing and safety

Manufacturer-hosted approved Chinese package insert

Innovent Biologics, approved June 24 and September 16, 2025

The Chinese package insert defines the weight-management and type 2 diabetes populations, 2 mg to 6 mg strengths, titration and missed-dose rules, contraindications, warnings, and GLORY-1 adverse-reaction frequencies.

Weight management: BMI at least 28, or at least 24 with a weight-related comorbidity.
Boxed thyroid C-cell tumor warning; contraindicated with MTC history or MEN2.
Stop at least three months before planned pregnancy.

Participants / model: Adults covered by the separate Chinese weight-management and type 2 diabetes indications
Treatment: Mazdutide 2 mg, 4 mg, or 6 mg per 0.5 mL once weekly
Follow-up: Weight label approved June 24, 2025; diabetes label approved September 16, 2025
Study design: Chinese-language prescribing document hosted by the marketing-authorization holder

This Chinese label governs the named product, not higher trial doses, U.S. use, or products of uncertain identity.

Read the original source

Has mazdutide directly beaten tirzepatide, semaglutide, or survodutide?

The GLORY and U.S. phase 2 reports were placebo controlled. Their percentages do not establish superiority to another incretin medicine.

GLORY-1 · two estimands explained

Randomized trial

New England Journal of Medicine, 2025

The 610-person trial reported both treatment-policy and efficacy estimands, explaining the 14.01% and 14.84% week-48 values.

Participants / model: Chinese adults with BMI at least 28, or 24 to below 28 plus a weight-related condition
Treatment: Weekly mazdutide 4 mg, 6 mg, or placebo
Follow-up: 48 weeks
Study design: Randomized, double-blind phase 3 trial

GLORY-1 studied Chinese adults and the approved Chinese product; it does not establish labeling or applicability in other countries. Chinese registry identifier: CTR20222567. Outcome data come from the published report and Chinese package insert.

Read the original source

GLORY-2 · 60-week phase 3 result

Randomized trial

JAMA, 2026

The trial reported -16.65% versus -1.50% mean weight change under the treatment-policy analysis and high gastrointestinal-event frequencies.

Participants / model: Chinese adults with BMI at least 30; 16.1% had type 2 diabetes
Treatment: Weekly mazdutide 9 mg or placebo
Follow-up: 60 weeks
Study design: Randomized, double-blind phase 3 trial

The overall analysis is not interchangeable with a no-diabetes subgroup or efficacy estimand. Chinese registry identifier: CTR20233902. The registry record is not used as an outcome report.

Read the original source

Mazdutide U.S. phase 2 · efficacy and tolerability

Randomized trial

Diabetes, Obesity and Metabolism, 2026

At 32 weeks, efficacy-estimand weight changes ranged from -7.3% to -18.1% versus -0.9% with placebo; adverse-event discontinuation reached 20% at 16 mg.

Participants / model: U.S. adults with overweight or obesity
Treatment: Three weekly mazdutide titration regimens or placebo
Follow-up: 32 weeks
Study design: Randomized, double-blind phase 2 trial

Short phase 2 follow-up and high-dose discontinuation limit inference about long-term U.S. use.

Read the original source

Do human trials show what glucagon-receptor activity contributes?

Mazdutide activates GLP-1 and glucagon receptors, but the outcome trials compared the whole molecule with placebo. They do not isolate how much weight loss, liver change, or adverse effect came from the glucagon-receptor arm.

Receptor pharmacology explains the design. A human contribution claim would require a suitable comparator that differs only in glucagon-receptor activity, or another validated causal analysis.

GLORY-1 · two estimands explained

Randomized trial

New England Journal of Medicine, 2025

The 610-person trial reported both treatment-policy and efficacy estimands, explaining the 14.01% and 14.84% week-48 values.

Participants / model: Chinese adults with BMI at least 28, or 24 to below 28 plus a weight-related condition
Treatment: Weekly mazdutide 4 mg, 6 mg, or placebo
Follow-up: 48 weeks
Study design: Randomized, double-blind phase 3 trial

GLORY-1 studied Chinese adults and the approved Chinese product; it does not establish labeling or applicability in other countries. Chinese registry identifier: CTR20222567. Outcome data come from the published report and Chinese package insert.

Read the original source

Mazdutide U.S. phase 2 · efficacy and tolerability

Randomized trial

Diabetes, Obesity and Metabolism, 2026

At 32 weeks, efficacy-estimand weight changes ranged from -7.3% to -18.1% versus -0.9% with placebo; adverse-event discontinuation reached 20% at 16 mg.

Participants / model: U.S. adults with overweight or obesity
Treatment: Three weekly mazdutide titration regimens or placebo
Follow-up: 32 weeks
Study design: Randomized, double-blind phase 2 trial

Short phase 2 follow-up and high-dose discontinuation limit inference about long-term U.S. use.

Read the original source

Studies and sources

Mazdutide · China regulatory status

Developer regulatory disclosure

Innovent Biologics, 2025

Innovent reports Chinese approvals for chronic weight management in June 2025 and type 2 diabetes in September 2025.

Participants / model: People covered by the Chinese approvals
Treatment: Commercial mazdutide under the Chinese label
Follow-up: Current as disclosed
Study design: Regulatory sponsor disclosure

The Chinese package insert, rather than the announcement, provides product strengths, contraindications, and dosing.

Read the original source

U.S. FDA · no mazdutide approval

FDA drug records

Drugs@FDA and openFDA records for mazdutide and IBI362.

The cited U.S. FDA databases list no approval record for mazdutide or IBI362.

Participants / model: United States drug approvals
Treatment: Mazdutide and IBI362

Read the original source

GLORY-1 · two estimands explained

Randomized trial

New England Journal of Medicine, 2025

The 610-person trial reported both treatment-policy and efficacy estimands, explaining the 14.01% and 14.84% week-48 values.

Participants / model: Chinese adults with BMI at least 28, or 24 to below 28 plus a weight-related condition
Treatment: Weekly mazdutide 4 mg, 6 mg, or placebo
Follow-up: 48 weeks
Study design: Randomized, double-blind phase 3 trial

GLORY-1 studied Chinese adults and the approved Chinese product; it does not establish labeling or applicability in other countries. Chinese registry identifier: CTR20222567. Outcome data come from the published report and Chinese package insert.

Read the original source

GLORY-2 · 60-week phase 3 result

Randomized trial

JAMA, 2026

The trial reported -16.65% versus -1.50% mean weight change under the treatment-policy analysis and high gastrointestinal-event frequencies.

Participants / model: Chinese adults with BMI at least 30; 16.1% had type 2 diabetes
Treatment: Weekly mazdutide 9 mg or placebo
Follow-up: 60 weeks
Study design: Randomized, double-blind phase 3 trial

The overall analysis is not interchangeable with a no-diabetes subgroup or efficacy estimand. Chinese registry identifier: CTR20233902. The registry record is not used as an outcome report.

Read the original source

Mazdutide U.S. phase 2 · efficacy and tolerability

Randomized trial

Diabetes, Obesity and Metabolism, 2026

At 32 weeks, efficacy-estimand weight changes ranged from -7.3% to -18.1% versus -0.9% with placebo; adverse-event discontinuation reached 20% at 16 mg.

Participants / model: U.S. adults with overweight or obesity
Treatment: Three weekly mazdutide titration regimens or placebo
Follow-up: 32 weeks
Study design: Randomized, double-blind phase 2 trial

Short phase 2 follow-up and high-dose discontinuation limit inference about long-term U.S. use.

Read the original source

Xinermei Chinese label · dosing and safety

Manufacturer-hosted approved Chinese package insert

Innovent Biologics, approved June 24 and September 16, 2025

The Chinese package insert defines the weight-management and type 2 diabetes populations, 2 mg to 6 mg strengths, titration and missed-dose rules, contraindications, warnings, and GLORY-1 adverse-reaction frequencies.

Weight management: BMI at least 28, or at least 24 with a weight-related comorbidity.
Boxed thyroid C-cell tumor warning; contraindicated with MTC history or MEN2.
Stop at least three months before planned pregnancy.

Participants / model: Adults covered by the separate Chinese weight-management and type 2 diabetes indications
Treatment: Mazdutide 2 mg, 4 mg, or 6 mg per 0.5 mL once weekly
Follow-up: Weight label approved June 24, 2025; diabetes label approved September 16, 2025
Study design: Chinese-language prescribing document hosted by the marketing-authorization holder

This Chinese label governs the named product, not higher trial doses, U.S. use, or products of uncertain identity.

Read the original source

NMPA June 2025 · Chinese weight indication

Chinese regulator approval announcement

National Medical Products Administration, June 27, 2025

NMPA announced approval of mazdutide injection for long-term weight management with diet and physical activity in the defined adult BMI populations.

Participants / model: Adults in China with BMI at least 28, or BMI at least 24 plus a weight-related comorbidity
Treatment: Mazdutide injection as an adjunct to diet and increased physical activity
Follow-up: Approval announced June 27, 2025
Study design: Chinese-language regulator announcement

Product guidance comes from the Chinese package insert rather than the NMPA database record.

Read the original source

CDE registry IDs · registry-only records

Chinese clinical-trial registry records

China CDE Drug Clinical Trial Registration and Information Platform

The program records include GLORY-1 CTR20222567, GLORY-2 CTR20233902, DREAMS-1 CTR20222875, and DREAMS-2 CTR20222740.

Participants / model: Chinese phase 3 weight-management and type 2 diabetes trial programs
Treatment: Mazdutide versus the trial-specific controls
Study design: Phase 3 registry records; published reports and the Chinese package insert provide the outcome data
Funding: Innovent Biologics

Published trial reports and the Chinese package insert, rather than the registry entries, support the outcome claims.

Read the original source

Why is mazdutide in A tier?

A reflects multiple randomized trials and approval in China. The approved Chinese 2 mg, 4 mg, and 6 mg product differs from US investigational programs and the 9 mg and 16 mg research regimens.