Mazdutide: Approved in China, Misdescribed Everywhere Else

Mazdutide is approved — in China, twice, under the brand name Xinermei® (信尔美). It is a glucagon receptor and GLP-1 receptor dual agonist, not a triple agonist, and the English-language peptide market routinely gets both facts wrong.

China's National Medical Products Administration cleared mazdutide for weight management in June 2025 and for glycaemic control in type 2 diabetes in September 2025, making it the only compound in this class besides semaglutide and tirzepatide with a live marketing authorisation anywhere in the world. It belongs to the weight loss and metabolic peptides category, and it is the member of that category most consistently described incorrectly.

Peptigrity's own mazdutide compound page says "Mazdutide is not approved by the FDA or EMA as of May 2026" without mentioning the Chinese approvals. Technically true, substantively misleading, and being corrected.

Is mazdutide approved anywhere?

Mazdutide holds two marketing authorisations from China's National Medical Products Administration: June 2025 for weight management alongside diet control and increased physical activity, and September 2025 for glycaemic control in adults with type 2 diabetes. It is sold there as Xinermei® (信尔美). Mazdutide is not approved in the United States — it is absent from FDA's novel approvals lists for 2025 and 2026 — and approval outside China we could not verify in either direction.

The primary source is a peer-reviewed drug monograph rather than a press release: Shirley M, "Mazdutide: First Approval," Drugs, December 2025 (PMID 41028652). Its statements, verbatim: "In June 2025, mazdutide received its first approval, in China, for use (in combination with diet control and increased physical activity)" for weight management, and "Subsequently, in September 2025, mazdutide also received approval in China for use in glycaemic control in adults with T2D."

Independent corroboration comes from a Lancet Diabetes & Endocrinology review of obesity in China, February 2026 (PMID 41389801): "Since 2021, five additional GLP-1 receptor agonists (including liraglutide, beinaglutide, semaglutide, tirzepatide, and mazdutide) have been approved in China for weight management."

Two limits on that record are worth stating plainly. We could not fetch China's NMPA announcement directly — the agency's site returned an error — so this article cites "June 2025" rather than the specific date that circulates in vendor copy. And while mazdutide is demonstrably absent from FDA's novel approvals lists for 2025 and 2026, its regulatory status in markets other than China and the United States is something we could not confirm in either direction.

Is mazdutide a triple agonist, and what does it actually bind?

No. Mazdutide is a dual glucagon receptor (GCGR) and GLP-1 receptor agonist with no GIP component at all, which makes the widespread "triple agonist" label simply wrong. Its molecular weight is 4,476.0 g/mol against tirzepatide's 4,813.0 and retatrutide's 4,731.0 — a separation of hundreds of daltons that mass spectrometry resolves easily and an HPLC purity certificate cannot see. CAS 2259884-03-0; developed as IBI-362 by Innovent and LY3305677 by Eli Lilly.

The mechanism is not a labelling technicality — it determines which lever the drug pulls. Glucagon receptor agonism raises energy expenditure, which is a different mechanism from the appetite suppression GLP-1 provides. That is the same pairing survodutide uses, and a different one from tirzepatide, which pairs GLP-1 with GIP.

The mass difference matters practically as well. Hundreds of daltons is trivially separable by mass spectrometry and entirely invisible on a purity certificate, because HPLC reports how pure a sample is, not what the sample is. A vial of tirzepatide mislabelled as mazdutide would return a clean purity figure. See mass spectrometry for peptides.

How much weight did mazdutide produce in GLORY-1 and GLORY-2?

Mazdutide produced 14.01% mean weight loss at 6 mg over 48 weeks in GLORY-1 (n=610, NCT05607680) and 16.65% at 9 mg over 60 weeks in GLORY-2 (n=461, NCT06164873), against placebo arms that barely moved — +0.30% and −1.50% respectively. Both are randomised placebo-controlled phase 3 trials in Chinese adults, published in the NEJM in June 2025 and JAMA in August 2026, with all comparisons at P<0.001.

GLORY-1 — Ji et al., NEJM, June 2025 (PMID 40421736). NCT05607680, n=610, 48 weeks, Chinese adults with obesity or overweight.

Responder rates track the means. At least 5% loss at week 32: 73.9% and 82.0% versus 10.5%. At least 15% loss at week 48: 35.7% and 49.5% versus 2.0%.

GLORY-2 — Gao et al., JAMA, 4 August 2026 (PMID 42251595). NCT06164873, n=461 (307 mazdutide / 154 placebo), 9 mg, 60 weeks. The result was −16.65% versus −1.50%, a difference of 15.15 percentage points, P<0.001, with at least 5% loss in 84.3% versus 33.1%.

One limitation applies to all of it: the trials enrolled Chinese adults, whose baseline body weight is generally lower than in Western obesity trials. That affects how the percentages transfer to other populations, and it is a reason to be cautious about placing mazdutide's numbers directly alongside SURMOUNT-1 or STEP-1.

Why did so few people stop taking mazdutide?

Discontinuation due to adverse events ran 0.5% to 2.9% across mazdutide's phase 3 obesity trials — 1.5% at 4 mg, 0.5% at 6 mg and 1.0% on placebo in GLORY-1, and 2.9% versus 0% in GLORY-2 — against 6.2% for tirzepatide in SURMOUNT-1. That happened despite common gastrointestinal effects at 9 mg: vomiting 53.1%, nausea 46.9%, diarrhoea 39.4%. Why participants tolerated those rates without leaving the trials is not established.

That combination is unusual enough to be worth stating twice: gastrointestinal adverse event rates that are not low at all, alongside the lowest discontinuation figures in this drug class. The two normally move together.

Three explanations are available and none of them has been tested. It may be the population — Chinese adults with lower baseline weight, in trials run entirely within one health system. It may be the titration schedule. It may be something about the molecule itself. Nothing in the published record distinguishes between them, and no trial outside China exists to test whether the figure travels.

The practical significance is not cosmetic. In a drug class where tolerability is the real-world limit on how many people benefit, a compound that people stay on may matter more than one that produces a larger number in the subset who complete.

What did mazdutide do to HbA1c in type 2 diabetes?

Mazdutide lowered HbA1c by 1.57 and 2.15 percentage points at 4 mg and 6 mg over 24 weeks, against 0.14% on placebo (n=320, P<0.0001), with weight down 5.61% and 7.81% versus 1.26% (P<0.0001). Those results come from one of two phase 3 papers published in Nature in April 2026 (PMIDs 41407859 and 41407860); the second compared mazdutide against dulaglutide. China's NMPA approved the diabetes indication in September 2025.

The diabetes programme is what makes the second Chinese approval a separate event rather than a label extension of the first. Two phase 3 publications in Nature is a substantial evidence base for the indication, and the trial that used dulaglutide as comparator is the only active-comparator study anywhere in mazdutide's record — a GLP-1 monotherapy comparison in T2D, not an obesity head-to-head against semaglutide or tirzepatide.

How does mazdutide compare with tirzepatide, CagriSema, semaglutide and survodutide?

Mazdutide's 16.65% at 9 mg sits below tirzepatide's 20.9% in SURMOUNT-1 and CagriSema's 20.4% in REDEFINE-1, above semaglutide's 14.9% in STEP-1, and above survodutide's 13.0% in SYNCHRONIZE-1. None of those comparisons is head-to-head, and mazdutide's trials enrolled Chinese adults whose baseline body weight is generally lower than in Western obesity trials, so the percentages do not transfer cleanly. Its discontinuation rate is the lowest in the table.

The tolerability column is where mazdutide separates from the field. Discontinuation of 0.5% to 2.9% is the lowest in this table by a wide margin. Read the weight column and mazdutide is mid-pack; read the discontinuation column and it is an outlier.

For the three-way breakdown of how the dual and triple agonists differ mechanically, see retatrutide versus survodutide versus mazdutide.

Which mazdutide claims survive contact with the evidence?

Two of the most common claims about mazdutide are false. It is not unapproved — China's NMPA cleared it twice in 2025 — and it is not a triple agonist, because it contains no GIP component. The efficacy claims mostly hold: 14.01% at 6 mg and 16.65% at 9 mg are both accurate to the published trials. The claim that it is poorly tolerated is contradicted by discontinuation rates of 0.5% to 2.9%.

Can mazdutide be compounded in the US, and is it prohibited in sport?

No US compounding pathway for mazdutide has ever existed. Compounding a copy of an approved drug requires that drug to be approved in the United States and in shortage; mazdutide has never been approved there, so it has never been in shortage. In the United States it is an unapproved new drug. On WADA's 2026 Prohibited List mazdutide is not named and no GLP-1 class entry exists, and its Chinese approval arguably places it outside the S0 catch-all.

Mazdutide does not appear on FDA's compounding lists. We enumerated both tables on the page current 22 April 2026 — no GLP-1, GIP, glucagon or amylin agonist is on either. That absence carries no permission. The shortage route that briefly legitimised compounded semaglutide and tirzepatide cannot apply to a drug that has never been approved in the US at all.

FDA's warning about this class applies directly: the agency has "warned companies that have illegally sold unapproved drugs... falsely labeled 'for research purposes' or 'not for human consumption.' These products have been sold directly to consumers for human use." See our FDA peptide regulation timeline.

The sport position is a genuine asymmetry. Because mazdutide holds an approval from a governmental regulatory health authority — China's NMPA — the S0 catch-all does not obviously capture it, unlike retatrutide, survodutide and cagrilintide, which hold no approval anywhere. That is an interpretation of S0's plain text rather than a published ruling, and an athlete should seek a determination rather than rely on it.

What do 30 lab tests and 9 shops in stock show about mazdutide supply?

Mazdutide averages 99.56% purity across 30 independent tests on the Peptigrity Purity Index (verified August 2026), from five labs — ILS, Janoshik, Liquilabs, Vanguard and BioRegen — with 218 shops selling. Thirty tests is thin next to 930 for tirzepatide and 1,150 for retatrutide. One April 2026 sample labelled 20 mg assayed at 15.18 mg — a 24.1% shortfall — while testing 99.80% pure, which is a quantity failure, not a purity failure.

That combination is the one buyers most often misread. High purity, badly wrong quantity. The material was what it claimed to be; there was a quarter less of it than the label said, and purity testing found no problem because there was no purity problem to find. See why 10 mg isn't 10 mg.

Mazdutide price data shows 9 shops in stock, median $11.00/mg, lowest $3.25/mg on a 10 mg vial (verified 10 August 2026), across 9 compared offers with vial prices from $32.50 to $209.00. Those figures exclude shipping, taxes and customs, coupon codes, bulk tiers, multi-vial kits and account-gated pricing.

Nine shops in stock and nine offers compared is a thin market — and, unusually for this category, one where an approved pharmaceutical version already exists in a major market. Those figures sit within 11,852 independent lab tests across 530 tracked shops (verified August 2026).

For per-injection volume once you have confirmed what is in the vial, use the peptide dosing calculator alongside the reconstitution calculator, and compare vendors on the mazdutide compound page.

The trial that would settle this

No trial of mazdutide has been run outside China, and none has compared it head-to-head against semaglutide or tirzepatide. The study that would resolve the open questions enrols non-Chinese adults with obesity, runs beyond GLORY-2's 60 weeks, uses an active comparator rather than placebo, and reports discontinuation prospectively to test whether the 0.5% to 2.9% figure holds in another population. No cardiovascular outcomes trial has been identified.

Frequently Asked Questions

Is mazdutide approved by the FDA?

No. Mazdutide is absent from FDA's novel approvals lists for 2025 and 2026, and in the United States it is an unapproved new drug. It is approved in China — for weight management since June 2025 and for glycaemic control in type 2 diabetes since September 2025, marketed as Xinermei®. Approval in any other jurisdiction we could not verify in either direction.

Is mazdutide a triple agonist?

No. Mazdutide is a dual glucagon receptor and GLP-1 receptor agonist and contains no GIP component. Tirzepatide is the GIP/GLP-1 dual; retatrutide is the GIP/GLP-1/glucagon triple. Survodutide uses the same glucagon-plus-GLP-1 pairing mazdutide does.

How much weight do people lose on mazdutide?

In GLORY-1, 14.01% at 6 mg over 48 weeks against a 0.30% gain on placebo. In GLORY-2, 16.65% at 9 mg over 60 weeks against 1.50%. Both trials enrolled Chinese adults, whose baseline weights are generally lower than in Western obesity trials, so the percentages should not be read as directly transferable.

How does mazdutide compare with tirzepatide?

On weight, tirzepatide is ahead: 20.9% at 15 mg in SURMOUNT-1 versus 16.65% at 9 mg in GLORY-2. On tolerability the order reverses — 6.2% discontinuation for tirzepatide against 2.9% for mazdutide. Neither trial included the other drug, so this is a cross-trial comparison in populations with different baseline weights, not a head-to-head result.

Can mazdutide be legally compounded in the United States?

No. Compounding a copy of an approved drug requires that drug to be approved in the US and in shortage. Mazdutide has never been approved in the US, so it has never been in shortage, and no such pathway has ever existed. It also does not appear on either FDA bulk drug substances compounding list.

Is mazdutide banned in sport?

It is not named on the WADA 2026 Prohibited List, and no GLP-1 class entry exists. Because mazdutide holds a governmental approval in China, the S0 catch-all for non-approved substances does not obviously apply — unlike retatrutide and survodutide, which hold no approval anywhere. That is our reading of S0's text, not a published ruling, and athletes should seek a formal determination.

What mazdutide's Chinese approval does and does not mean

Mazdutide's approval is real and geographically narrow. Two NMPA authorisations in 2025 make it the only compound in this class besides semaglutide and tirzepatide with a live marketing authorisation anywhere in the world, and they rest on four phase 3 papers in the NEJM, JAMA and Nature. What those approvals do not do is license it in the United States, transfer its Chinese trial percentages to Western populations, or say anything about cardiovascular outcomes, which remain untested.

The English-language market has mischaracterised mazdutide in two directions at once. It is described as unapproved and investigational, when it has held two Chinese marketing authorisations since 2025 and is sold under a brand name. And it is described as a triple agonist, when it pairs glucagon with GLP-1 and contains no GIP at all.

The most interesting number in its file is not the weight loss. It is the discontinuation rate of under 3%. In a drug class where tolerability is the practical limit on how many people benefit, a compound people stay on may matter more than one that produces a bigger number in the participants who complete. Whether that figure survives contact with a non-Chinese population is the open question, and no trial has been run to answer it.

Browse the weight loss and metabolic peptides category, or our complete peptide guide with 118 compounds (verified August 2026). For per-injection volume, use the peptide dosing calculator alongside the reconstitution calculator. Compare shops through independent lab tests and community-verified shop reviews.

This article is for educational and informational purposes only and does not constitute medical advice. Peptides discussed may be investigational compounds not approved by the FDA (or equivalent regulators in your jurisdiction) for human use. Always consult a qualified healthcare provider before using any peptide or research compound. Peptigrity is an independent review platform and does not sell, endorse, or recommend specific products or vendors.