Is mazdutide FDA-approved, and what does the research show?

What is mazdutide?

Mazdutide is a peptide drug. It is a dual agonist: one molecule that switches on two hormone receptors, the glucagon receptor and the GLP-1 receptor ¹, ². GLP-1, glucagon-like peptide-1, is an incretin, a gut hormone that prompts the pancreas to release insulin after a meal ¹². Semaglutide acts on the GLP-1 receptor alone, and tirzepatide pairs GLP-1 with GIP, glucose-dependent insulinotropic polypeptide, a second gut hormone ¹². Mazdutide pairs GLP-1 with glucagon instead ¹, ².

The manufacturer calls it the first dual glucagon and GLP-1 receptor agonist approved anywhere for weight loss ². Mazdutide is an analog of oxyntomodulin, a natural gut hormone ². Innovent Biologics holds an exclusive license from Eli Lilly and Company to develop and sell it in China ². In China it is sold as Xinermei ¹. Lilly runs the trials in the United States ⁹, ³, ¹¹, ¹³.

Is mazdutide FDA-approved?

Mazdutide is not FDA-approved: Drugs@FDA lists no approved mazdutide product as of November 9, 2026 ⁵. It is an investigational drug in the United States, where its trials have reached phase 2, none phase 3 ⁹, ³, ¹¹, ¹³. No approved product means no FDA label: the prescribing and safety information an approved drug carries does not exist for mazdutide in the United States ⁵. No source opened for this page names a route by which mazdutide is obtained in the United States outside a clinical trial ⁵.

China is a different matter. Its National Medical Products Administration, the NMPA, approved mazdutide on June 27, 2025, in the manufacturer's words "for chronic weight management in Chinese adults with overweight or obesity" ². The approved indication covers adults with a body mass index of 28 or more, or of 24 or more with a weight-related condition ¹, ². The approved indication is as an adjunct to a reduced-calorie diet and increased physical activity ². On September 19, 2025, the NMPA approved a second indication, glycemic control in adults with type 2 diabetes, alone or added to oral diabetes drugs ¹, ⁶.

The approvals rested on three phase 3 trials run in China, GLORY-1, DREAMS-1 and DREAMS-2 ², ⁶. An approval in China is not an FDA approval, and Drugs@FDA lists no mazdutide application ⁵.

See the FDA status of every peptide, updated weekly.

How does mazdutide work?

Mazdutide acts on two receptors, the GLP-1 receptor and the glucagon receptor ¹, ¹⁰. Drugs that act on the GLP-1 receptor stimulate insulin release after food, delay stomach emptying, and curb glucagon release when blood sugar is high ¹². The glucagon arm's contribution is proposed ².

Glucagon receptors sit mainly in the liver, and the manufacturer says activating them "may also increase energy expenditure and improve hepatic fat metabolism" ². The phase 3 trials measured what the drug did to weight and blood sugar, not which receptor did it ⁷, ⁸, ¹⁰, ¹⁴.

What does the research show?

Studied in people: GLORY-1, a randomized, double-blind, placebo-controlled phase 3 trial, 610 Chinese adults with obesity or overweight, weight change at 32 weeks ⁸. Mean weight fell by 10.1% and 12.6% in the two mazdutide groups, against a rise of 0.5% with placebo ⁸. At 48 weeks the falls were 11.0% and 14.0%, against a rise of 0.3% ⁸. Weight loss of at least 5% at 32 weeks was reached by 73.9% and 82.0% of the two mazdutide groups, against 10.5% on placebo ⁸.

The trial's entry criteria admitted a body mass index of 24 with a weight-related condition, lower than the 27 the United States phase 2 trial required ⁸, ⁹. The paper was published online May 25, 2025, and was the pivotal study for the China approval ⁸, ².

Studied in people: GLORY-2, a randomized, double-blind, placebo-controlled phase 3 trial, 462 Chinese adults with obesity randomized and 461 treated, weight change at 60 weeks ⁷. This trial tested a higher dose than GLORY-1 in adults with a body mass index of 30 or more, 16.1% of them with type 2 diabetes ⁷. Mean weight fell by 16.65% with mazdutide, against 1.50% with placebo, a difference of 15.15 percentage points ⁷. Weight loss of at least 5% was reached by 84.3% against 33.1% ⁷. The paper was published online June 7, 2026 ⁷.

Studied in people: a randomized, double-blind, placebo-controlled phase 2 trial, 179 United States adults with obesity or overweight and without type 2 diabetes, weight change at 32 weeks ⁹. At 32 weeks mean weight fell by 7.3%, 15.6% and 18.1% across the three mazdutide groups, against 0.9% with placebo ⁹. Those figures come from the analysis the paper calls the "efficacy (hypothetical) estimand" ⁹. Weight fell further by 48 weeks ⁹. It was a dose-finding study funded by Lilly ⁹, ³.

Studied in people: a randomized, double-blind, placebo-controlled phase 1 trial, 32 United States adults with obesity or overweight and without diabetes, weight change at 20 weeks ¹³. Mean weight fell by 20.0% and 21.0% in its two mazdutide groups, against 0.1% with placebo ¹³. No serious adverse events were reported, and the most common adverse events were mild or moderate gastrointestinal disorders ¹³. As of November 9, 2026 these two Lilly studies are the published United States trials of mazdutide, and neither is phase 3 ⁹, ³, ¹³.

Studied in people: DREAMS-1, a randomized phase 3 trial, 320 Chinese adults with type 2 diabetes not controlled by diet and exercise, blood sugar at 24 weeks ¹⁰. Glycated hemoglobin, a measure of average blood sugar, fell by 1.57 and 2.15 percentage points in the two mazdutide groups, against 0.14 with placebo ¹⁰. Weight fell by 5.61% and 7.81%, against 1.26% ¹⁰.

Studied in people: DREAMS-2, a randomized phase 3 trial, 731 Chinese adults with type 2 diabetes on oral diabetes drugs, blood sugar at 28 weeks ¹⁴. The comparator was dulaglutide, an FDA-approved GLP-1 drug, not placebo ¹², ¹⁴. Glycated hemoglobin fell 0.24 and 0.30 percentage points more with mazdutide than with dulaglutide, and weight fell 3.78 and 5.76 percentage points more ¹⁴.

A systematic review and meta-analysis published online July 6, 2026 pooled nine randomized trials of 2,292 adults, searched to February 20, 2026 ¹⁵. In adults with obesity or overweight and no diabetes, it rated the certainty of the weight evidence "very low," because of heterogeneity between trials and their small number ¹⁵. In type 2 diabetes it rated the certainty moderate ¹⁵. Its authors called the participants "predominantly Chinese" and asked for "longer-term, multi-ethnic studies" to confirm durability, generalizability and cardiovascular safety ¹⁵.

The published trials ran 60 weeks at most, and none measured heart attacks, strokes or deaths as an outcome ⁷, ⁸, ⁹, ¹⁰, ¹⁴. A Lilly phase 2 trial in 308 United States adults with alcohol use disorder completed in May 2026, with no results in any source opened for this page ¹¹.

What are the side effects?

Gastrointestinal effects were the most frequent adverse events in each trial opened ⁷, ⁸, ⁹, ¹⁰, ¹⁴. In GLORY-2, 461 treated Chinese adults with obesity, vomiting affected 53.1% of the mazdutide group against 1.3% on placebo ⁷. Nausea affected 46.9% against 3.2%, and diarrhea 39.4% against 6.5% ⁷. Most events were mild to moderate, and adverse events led 2.9% of the mazdutide group to stop treatment, against none on placebo ⁷.

In GLORY-1, 610 Chinese adults with obesity or overweight, the most frequent adverse events were gastrointestinal and mostly mild to moderate ⁸. Adverse events led 1.5% and 0.5% of the two mazdutide groups to stop, against 1.0% on placebo ⁸.

In the United States phase 2 trial, 179 adults with obesity or overweight, adverse events led 20% of the highest-dose group to stop, mostly for gastrointestinal disorders ⁹. In DREAMS-1, 320 adults with type 2 diabetes, the most common adverse events were diarrhea, decreased appetite and nausea ¹⁰. In DREAMS-2, 731 adults with type 2 diabetes, gastrointestinal adverse events were more frequent with mazdutide than with dulaglutide ¹⁴. The 2026 meta-analysis found gastrointestinal events more frequent with mazdutide, while serious adverse events and treatment discontinuation were comparable with the comparators ¹⁵.

FDA has approved no mazdutide product, so no FDA label exists to quote on safety ⁵. The manufacturer says the diabetes trials showed "no new safety signals" against earlier studies and other GLP-1 drugs; those are the company's words ⁶. FDA-approved GLP-1 drugs carry class concerns about pancreatitis and about thyroid C-cell tumors seen in rodents, and no opened source tests whether they apply to mazdutide ¹².

In sport

Mazdutide is not named on WADA's 2026 Prohibited List ¹⁶. WADA is the World Anti-Doping Agency. Neither its peptide-hormone section S2 nor its metabolic-modulator section S4 names mazdutide, and the list mentions neither glucagon nor GLP-1 ¹⁶. Section S0 reads: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times" ¹⁶. China's National Medical Products Administration has approved mazdutide and FDA has not ⁵, ², ⁶.

What JumpstartMD offers

JumpstartMD does not prescribe mazdutide. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 9, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.