drug

Mazdutide

Definition

An investigational GLP-1 + glucagon dual receptor agonist developed by Innovent Biologics, marketed in China as 信尔达 (Xinerda). Approved by China's NMPA in March 2025 for chronic weight management. Not FDA-approved or available in the United States.

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Definition curated by Weight Loss Rankings — sourced from FDA labels and peer-reviewed PubMed literature, never AI-generated summaries.

Mazdutide in plain English

Mazdutide is a once-weekly injectable that activates both the GLP-1 receptor and the glucagon receptor. It is developed by Innovent Biologics and is not FDA-approved and not available in the United States. Most of its clinical development has taken place in China.

A US-based phase 2 trial published in Lancet Diabetes & Endocrinology in 2026 gives the clearest picture for an American reader. It randomized 179 adults without type 2 diabetes — BMI 30 or higher, or 27 to under 30 with a weight-related condition — across 24 US centers to placebo or mazdutide at 3–6 mg, 10 mg or 16 mg for 48 weeks. At 32 weeks, mean body weight change was -7.3% at 3–6 mg, -15.6% at 10 mg and -18.1% at 16 mg, versus -0.9% on placebo, with further reduction by 48 weeks.

Tolerability tracked the dose. Gastrointestinal events dominated and were mostly mild to moderate, but discontinuation because of adverse events was most common at the 16 mg dose, at 20% — one in five people stopping at the dose that produced the largest weight loss. That trade-off is the central question for any high-dose incretin.

Two cautions. This was a phase 2 trial in 179 people, so the estimates are less precise than the numbers suggest, and a US phase 3 program plus an FDA review would have to follow before anyone here could be prescribed it. Approval in one country is not approval in another; regulatory decisions are made jurisdiction by jurisdiction, on the dossier submitted there.

The practical warning is about sourcing. Drugs that are approved abroad but not here are a recurring theme in online peptide marketplaces, and buying one means no FDA oversight of the product you receive. Worth asking your clinician: which approved options you have not yet tried. Our pipeline tracker, pharmacy legitimacy lookup and dual and triple agonist pipeline review cover what is real today.

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Sources

  1. Hsia SH et al. Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2026, PMID 42628555
  2. Noureddin M et al. Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT). Lancet. 2025;406(10520):2644-2655, PMID 41237796