China approves mazdutide, the world's first GLP-1/glucagon dual agonist

China's National Medical Products Administration approved mazdutide in June 2025 for weight management, making it the first GLP-1/glucagon (GCG) receptor dual agonist approved anywhere in the world ^[2]. The drug comes from Innovent Biologics, which licensed it from Eli Lilly for China; Lilly retains the rights outside China ^[1][2].

Mazdutide added a second Chinese indication three months later. On September 19, 2025, Innovent announced that the NMPA had also approved it for glycemic control in adults with type 2 diabetes — again, the first dual GCG/GLP-1 receptor agonist cleared for that use ^[1].

What the drug does differently

Mazdutide is a mammalian oxyntomodulin analogue. On top of the familiar GLP-1 effects — more insulin secretion, lower blood sugar, less body weight — activating the glucagon receptor may also increase energy expenditure and change how the liver handles fat ^[1]. Innovent says trials have shown reductions in waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes and liver fat, plus better insulin sensitivity ^[1].

The diabetes approval rested on two Phase 3 trials in Chinese adults. In DREAMS-1, at week 24, average HbA1c fell 1.57% on mazdutide 4 mg and 2.15% on 6 mg, versus 0.14% on placebo; 68.6% and 87.4% of participants reached HbA1c below 7%, versus 10.7% on placebo. Average weight change was −5.61% and −7.81%, versus −1.26% ^[1].

In DREAMS-2, which compared mazdutide with dulaglutide 1.5 mg in people not well controlled on oral drugs, week-28 HbA1c dropped 1.69% (4 mg) and 1.73% (6 mg) versus 1.38% for dulaglutide. Weight fell 7.31% and 9.24% versus 2.86% ^[1]. Innovent said safety looked consistent with earlier studies and other GLP-1 receptor agonists, with no new safety signals ^[1].

Seven Phase 3 trials have been run or are running, including GLORY-1 in overweight or obesity, GLORY-2 in moderate-to-severe obesity, GLORY-3 against semaglutide in people with fatty liver disease, GLORY-OSA in obstructive sleep apnea, and DREAMS-3 against semaglutide in type 2 diabetes with obesity. GLORY-1, DREAMS-1 and DREAMS-2 met their primary endpoints; the other four are ongoing ^[1]. Studies in adolescents with obesity, in MASH and in heart failure with preserved ejection fraction are started or planned ^[1].

Why it matters for patients

For US patients, the practical answer today is simple: mazdutide is a China-only product. Nothing in these sources shows an FDA submission, a US trial program under Lilly, or a projected American launch date, so US availability is not yet known. An approval in China does not create access here, and drugs bought from overseas sellers fall outside the FDA system.

What the approval does signal is where the field is heading. Independent industry analysis groups mazdutide with Boehringer Ingelheim's survodutide as GLP-1/glucagon duals, a route that is being positioned around liver disease and energy expenditure rather than pure appetite suppression ^[2]. That same analysis places multi-agonism as the efficacy frontier, noting Lilly's triple agonist retatrutide produced roughly 24% weight loss in Phase 2 against about 22% for tirzepatide ^[2]. Readers should note that source is an AI-generated competitive report, not peer-reviewed data, and it includes forward-looking dates.

One detail patients may recognize is device design. Innovent describes a single-use pen with a hidden needle and a cross-section needle tip intended to make injections less painful and reduce contamination risk from reuse ^[1]. Injection experience is often cited as a reason people stop treatment, and it is becoming a competitive feature, not an afterthought.

The trial numbers also come with a caveat: DREAMS-1 and DREAMS-2 enrolled Chinese participants ^[1], and the sources do not report results in US or other populations. Head-to-head data against semaglutide from GLORY-3 and DREAMS-3 had not been reported as of the September 2025 announcement ^[1].

What happens next

June 2025: China approves mazdutide for weight management ^[2]. September 19, 2025: China approves the type 2 diabetes indication ^[1]. Still pending: results from GLORY-2, GLORY-3, GLORY-OSA and DREAMS-3, plus the adolescent, MASH and heart failure studies ^[1]. Any US pathway would run through Lilly, which holds ex-China rights ^[1][2]; no timeline appears in these sources.