Mazdutide

Mazdutide is a real dual GLP-1/glucagon receptor agonist — the same mechanism this site's survodutide page covers — but unlike survodutide, it's already an approved medicine, cleared by China's National Medical Products Administration for weight management (2025) and type 2 diabetes (2025) on the strength of multiple large Phase 3 trials. It's also not approved anywhere in the West, has no pending US application, and — under its own name — is already the specific substance cited in several of this site's own 2026 FDA warning letters to online sellers marketing it as an unapproved injectable.

A dual agonist that's actually been approved somewhere

Mazdutide (Innovent code IBI362; Eli Lilly code LY3305677) activates both the GLP-1 receptor and the glucagon receptor — the same mechanistic combination as survodutide, this site's other dual-agonist page, though the two are chemically unrelated molecules from different companies. Where survodutide is still investigational everywhere, mazdutide has crossed into being a real, approved medicine: a synthetic peptide analog of oxyntomodulin (a natural gut peptide that itself weakly activates both receptors), engineered with a fatty-diacid side chain attached through a short linker for reversible albumin binding — the same broad chemistry family as insulin icodec's once-weekly modification, applied here to a GLP-1/glucagon peptide instead of insulin. Eli Lilly originated the molecule and licensed China development and commercialization rights to Innovent Biologics, retaining rights everywhere else itself.

GLORY-1: the Phase 3 weight-management trial

Mazdutide's weight-management approval rests on GLORY-1 (Ji L, Jiang H, Bi Y, et al., for the GLORY-1 investigators, "Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight," N Engl J Med 2025;392(22):2215-2225, PMID 40421736, DOI 10.1056/NEJMoa2411528), a randomized, double-blind, placebo-controlled trial that enrolled 610 Chinese adults with obesity (BMI ≥28) or overweight with a weight-related comorbidity (BMI 24-28), randomized to once-weekly mazdutide 4mg, 6mg, or placebo for 48 weeks. At week 48, mean body weight fell 11.00% with the 4mg dose and 14.01% with the 6mg dose, versus a 0.30% gain on placebo — a real, adequately powered, placebo-controlled result, not an open-label or single-arm study.

DREAMS-1 and GLORY-2: diabetes, and a higher dose

Mazdutide's type 2 diabetes approval rests primarily on DREAMS-1 (Zhu D, Zhao J, Cai H, et al., "Mazdutide versus placebo in Chinese adults with type 2 diabetes," Nature, published online 17 December 2025, print edition 2026;652:174-180, DOI 10.1038/s41586-025-10026-w), which randomized 320 Chinese adults with type 2 diabetes inadequately controlled by diet and exercise alone (mean baseline HbA1c 8.24%) to mazdutide 4mg, 6mg, or placebo for 24 weeks, finding statistically significant superiority over placebo on both glycemic control and weight loss; a companion trial, DREAMS-2 (same journal issue, DOI 10.1038/s41586-025-10031-z), tested mazdutide as an add-on to existing oral diabetes drugs. Separately, GLORY-2 (Ji L, et al., "Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial," JAMA 2026;336(5):377-388, PMID 42251595) tested a higher, 9mg dose in 462 Chinese adults with obesity (16% of whom also had type 2 diabetes) at 27 hospitals, finding a mean 18.55% weight reduction at 60 weeks versus 3.02% on placebo across the whole trial population — rising to 20.08% among the subgroup without type 2 diabetes — and meeting all prespecified secondary endpoints. Innovent has also announced (as a company press release, not yet a peer-reviewed publication as of this review) head-to-head superiority results against semaglutide and dulaglutide in separate trials — real, specific claims, but not yet independently scrutinized the way the NEJM, Nature, and JAMA papers have been.

Approved in China, and already named in FDA warning letters here

That's a genuinely different situation from most drugs on this site marked "approved elsewhere, not in the US" — mazdutide isn't sitting in an FDA review queue awaiting a decision the way insulin icodec or somatrogon once were. It's a real Chinese prescription medicine, with real Phase 3 evidence, that a US buyer can currently only obtain through the same unauthorized-seller channel the FDA has already sent multiple 2026 warning letters over — not a regulatory-timing story, but a plain access-and-legality one.

Current status

Innovent Biologics markets mazdutide in China under Eli Lilly's license for that market; Eli Lilly itself was still running earlier-stage US clinical trials of the same molecule as of this review, with no Biologics License Application or New Drug Application filed with the FDA and no announced US approval timeline. Given how quickly this specific drug class has moved in past years, its Western regulatory status is worth checking against a current source rather than assuming today's China-only picture holds indefinitely.