2026-08-18 · mazdutide, signifor, IBI362, glucagon, GLP-1, next-generation obesity drug, china nmpa, innovent, eli lilly, pipeline drugs

What is mazdutide and how does it work?

Mazdutide (development code IBI362, brand name Signifor in China) is a once-weekly subcutaneous dual agonist that activates both the GLP-1 receptor and the glucagon receptor. It was developed by Innovent Biologics under a China license from Eli Lilly's original oxyntomodulin platform. The GLP-1 arm suppresses appetite, slows gastric emptying, and improves insulin secretion — the same mechanism that drives Ozempic and Wegovy. The glucagon arm raises resting energy expenditure by roughly 5 percent and mobilizes fat out of the liver, which is why mazdutide's waist-circumference and liver-fat reductions run ahead of pure GLP-1 comparators at matched weight loss. It is administered as a weekly injection at doses from 3 mg to 9 mg.

How much weight do people lose on mazdutide?

In the GLORY-1 Phase 3 obesity trial (n=610 Chinese adults, 48 weeks), mean total body weight loss was roughly 11.0 percent at the 6 mg dose and roughly 14.4 percent at the 9 mg dose, compared with roughly 0.3 percent on placebo. About 82 percent of the 6 mg arm and 85 percent of the 9 mg arm reached at least 5 percent weight loss; waist circumference dropped by roughly 10.9 cm at 9 mg. These numbers sit between semaglutide's roughly 15 percent (STEP-1) and tirzepatide's roughly 20.9 percent (SURMOUNT-1), and the trial was conducted in an Asian population with lower average baseline weight than US trials — magnitude in a US population is expected to translate but is not yet directly measured.

Is mazdutide approved in the United States?

No. Mazdutide is not FDA-approved and is not commercially available in the United States as of August 2026. It was approved by China's National Medical Products Administration (NMPA) in June 2025 for chronic weight management and for type 2 diabetes, and it is on the market in China as Signifor. Eli Lilly holds ex-China rights and is expected to file the New Drug Application with the FDA in 2027. A realistic US commercial launch window is 2028 to 2029, and any earlier date is speculation.

How does mazdutide compare to tirzepatide (Mounjaro / Zepbound)?

Mazdutide and tirzepatide are different mechanisms. Tirzepatide is a GLP-1 / GIP dual agonist and produced roughly 20.9 percent weight loss at 72 weeks in SURMOUNT-1 at the 15 mg dose. Mazdutide is a GLP-1 / glucagon dual agonist and produced roughly 14.4 percent at 48 weeks in GLORY-1 at the 9 mg dose. There is no head-to-head trial, but tirzepatide is meaningfully more potent for pure weight loss in the current published data. Where mazdutide is expected to differ is on liver fat and cardiometabolic surrogates — the glucagon arm drove roughly a 32 percent reduction in liver fat on MRI-PDFF in the DREAMS-2 substudy, ahead of what pure GLP-1 drugs deliver at matched weight loss.

What are the side effects of mazdutide?

The safety profile from GLORY-1 and DREAMS is class-typical GLP-1 tolerability plus a small glucagon signal. Nausea occurred in roughly 30 to 40 percent of patients, vomiting in roughly 12 to 18 percent, diarrhea in roughly 18 to 22 percent, and decreased appetite in roughly 22 to 28 percent — mostly during titration. Discontinuation for tolerability was about 5 percent at the 9 mg dose. Glucagon-attributable signals were a mild heart-rate elevation of roughly 3 to 5 beats per minute and a transient rise in liver enzymes in the first 8 weeks that usually resolved. No new pancreatitis or gallbladder signal beyond GLP-1-class baseline was reported. No thyroid C-cell tumor signal appeared in the Chinese Phase 3 dataset.

How much does mazdutide cost?

In China, retail pricing at launch is approximately 2,000 to 2,800 yuan per month, or roughly US$275 to US$390 per month at 2026 exchange rates. That price band reflects the Chinese market and does not translate directly to US pricing when Lilly launches domestically. If Lilly anchors mazdutide near the current US injectable GLP-1 class list price (Wegovy roughly US$1,349 per month, Zepbound roughly US$1,059 per month in 2026), the realistic US launch band is US$800 to US$1,200 per month list, with cash-pay and payer channels below that. Mazdutide is not covered by US insurance because it is not yet approved.

Can I get mazdutide through a compounding pharmacy?

No. Two facts govern this. Mazdutide has never been on the FDA drug-shortage list — the trigger that briefly opened 503A / 503B compounding for semaglutide and tirzepatide during their 2022 to 2024 shortages. And the active pharmaceutical ingredient is proprietary to Innovent and Lilly; no US compounding pharmacy has legal access to it. Any product sold in the US as 'mazdutide' by a telehealth peptide clinic, gray-market compounder, or overseas pharmacy is either counterfeit or an unrelated peptide, not the drug from the GLORY-1 trial. FDA compounding enforcement actions in 2024 and 2025 targeted exactly this pattern of gray-market GLP-1 marketing.

When will mazdutide be available in the US?

Realistically 2028 to 2029, assuming no development or regulatory delays. Eli Lilly holds ex-China rights and is expected to file the FDA NDA in 2027 using a mix of Innovent's Chinese Phase 3 data and a bridging or confirmatory US trial. A standard 10-month FDA review would put earliest approval in late 2028; commercial pharmacy availability typically follows approval by two to six months. That timeline can shift if a US bridging trial is required, if manufacturing scale-up encounters issues, or if the FDA advisory committee raises specific questions about the glucagon-arm cardiovascular signal. In the meantime, the only mazdutide on the market anywhere is the Innovent Signifor product in China.

Mazdutide (Signifor) for Weight Loss: China Approval, GLORY-1 Data, and What US Patients Need to Know

Mazdutide is not FDA-approved and is not sold anywhere in the United States as of August 2026 — no legitimate pharmacy, telehealth clinic, or compounding operation can supply it. It was approved by China’s National Medical Products Administration (NMPA) in June 2025 for both obesity and type 2 diabetes, and it is on the market in China as Signifor through Innovent Biologics. Eli Lilly holds ex-China rights and is expected to file a New Drug Application with the FDA in 2027. A realistic US launch window is 2028 to 2029. Any product marketed in 2026 as “mazdutide” from an overseas pharmacy, telehealth peptide site, or gray-market compounder is either counterfeit or research-chemical peptide — see compounded semaglutide and tirzepatide safety for the analytical picture on what actually shows up in those vials.

This page explains what mazdutide is, what the GLORY-1 and DREAMS Phase 3 trials showed, how it compares to the drugs already on pharmacy shelves (tirzepatide, semaglutide) and to the other pipeline candidates mapped in the next generation weight loss drugs pillar, and what the realistic 2026 read is for US patients.

What mazdutide is

Mazdutide (development code IBI362, marketed in China as Signifor) is a once-weekly subcutaneous dual agonist that activates two receptors in one molecule: the GLP-1 receptor and the glucagon receptor. It is a mammalian oxyntomodulin analog, structurally engineered from the endogenous gut hormone oxyntomodulin, which already binds both receptors in native biology. The molecule was developed by Innovent Biologics under a China license from Eli Lilly’s original oxyntomodulin research platform.

Doses studied in the pivotal Phase 3 program are 3 mg, 4.5 mg, 6 mg, and 9 mg weekly. The China NMPA label lists 9 mg as the target dose for chronic weight management and 6 mg as the target dose for type 2 diabetes.

The mechanism separates mazdutide from every other GLP-1-class drug on the current US market. Tirzepatide (Zepbound, Mounjaro) is a GLP-1 / GIP dual agonist. Semaglutide (Wegovy, Ozempic) is a pure GLP-1 agonist. Mazdutide’s glucagon co-agonism is a distinct third mechanism — glucagon’s traditional role of mobilizing hepatic glucose and fat, harnessed in the context of GLP-1 co-signaling to add a resting-energy-expenditure lever that pure GLP-1 drugs do not activate.

How mazdutide compares to other next-generation obesity drugs

The comparison below sets mazdutide against the five other next-generation obesity molecules covered on this site. Only mazdutide is approved for obesity anywhere in the world today.

Two things to read from that table. First, mazdutide is the only drug on the list approved anywhere in the world for obesity today — China NMPA cleared it in June 2025. Second, for pure weight-loss magnitude in a US-relevant population, tirzepatide is meaningfully ahead. Mazdutide’s mechanistic advantage is expected to show up on liver-fat and cardiometabolic surrogate endpoints, not on the scale.

GLORY-1: the pivotal Phase 3 obesity trial

GLORY-1 (Ji L et al., reported in New England Journal of Medicine 2025) is the pivotal obesity trial that anchored the China NMPA approval. It enrolled 610 Chinese adults with obesity (BMI ≥28, or BMI ≥24 with at least one weight-related comorbidity) and randomized them to mazdutide 6 mg weekly, mazdutide 9 mg weekly, or matching placebo, on top of lifestyle counseling, for 48 weeks.

Waist circumference dropped by roughly 10.9 cm at the 9 mg dose. Secondary endpoints included lipid, blood-pressure, and HbA1c improvements consistent with a GLP-1-class response, plus MRI-PDFF liver-fat reductions large enough to draw a separate MASH-substudy pre-specification.

Two honest limitations on how to read GLORY-1 for a US audience. First, the trial population was Chinese, with a lower average baseline body weight than a US obesity population; absolute weight loss in pounds may look different in a US bridging trial. Second, 48 weeks is one year — durability beyond that is inferred from open-label extension data, not measured in the pivotal.

Phase 3 diabetes data (DREAMS-1 and DREAMS-2)

The China NMPA T2D approval rests on the DREAMS Phase 3 program. DREAMS-1 (Ji L et al., Lancet Diabetes & Endocrinology 2024) and DREAMS-2 enrolled adults with type 2 diabetes on background metformin and reported HbA1c reductions of roughly 1.5 to 2.0 percent at 24 weeks across the 4.5 mg and 6 mg doses, with weight loss of roughly 6 to 8 percent as a secondary endpoint. That magnitude is comparable to tirzepatide’s SURPASS-2 numbers.

The DREAMS-2 substudy also reported an MRI-PDFF liver-fat reduction of roughly 32 percent at 24 weeks — a signal large enough that Innovent has advanced mazdutide into a dedicated Phase 3 MASH program in parallel. For the broader picture of how MASH-active weight-loss drugs are converging, see resmetirom (Rezdiffra) for MASH.

Efficacy dose-response

The dose-response curve is steep across the studied range and plateaus above 6 mg for T2D indications while continuing to climb for obesity.

The China label lands on 9 mg as the target obesity dose and 6 mg as the target T2D dose. That split matters clinically — the incremental T2D benefit above 6 mg is small, while the incremental obesity benefit from 6 mg to 9 mg is meaningful.

How mazdutide works (glucagon co-agonism)

The two-mechanism story is what makes mazdutide different from every currently-approved US drug.

GLP-1 arm. Same as semaglutide: activates the GLP-1 receptor on pancreatic beta-cells, on hypothalamic satiety circuits, and on gastric and intestinal smooth muscle. Downstream effects are glucose-dependent insulin secretion, delayed gastric emptying, and appetite suppression — the mechanism that produces the shared class effect across every GLP-1-based drug.

Glucagon arm. Activates the glucagon receptor on hepatocytes. In isolation, glucagon raises blood sugar during fasting. In co-agonism with GLP-1, the net glucose effect is neutral or favorable — GLP-1’s insulinotropic action offsets the glucagon-driven hepatic glucose output. What is left is a distinct set of glucagon-driven effects: increased resting energy expenditure (roughly 5 percent) through hepatic β-oxidation, mobilization of hepatic fat (the mechanistic basis for the MRI-PDFF signal), and a modest lipid and adiposity redistribution effect.

The clinical read: waist circumference reductions and liver-fat reductions on mazdutide run ahead of pure GLP-1 comparators at matched weight loss. That is the signature of the glucagon arm — the same mechanism that drives the retatrutide triple-agonist story and the survodutide dual-agonist story mapped on the pipeline pillar. Cegla 2021 (Nature Reviews Endocrinology) is the canonical mechanism reference.

Safety and side effects

The GLORY-1 and DREAMS safety pictures are a class-typical GLP-1 tolerability profile, titration-limited, plus two glucagon-attributable signals.

No pancreatitis, gallbladder, or medullary thyroid carcinoma signal beyond the existing GLP-1 class baseline appeared in the Chinese Phase 3 dataset. A dedicated cardiovascular outcome trial analogous to SELECT (semaglutide) has not been reported — cardiovascular benefit is currently inferred from lipid, blood-pressure, and glucose surrogate improvements only. FDA and EMA reviews of the safety database will happen when Lilly files.

Approval status and access

China NMPA (June 2025). Approved for chronic weight management (BMI ≥28, or BMI ≥24 with weight-related comorbidity) and separately for type 2 diabetes on the same label date. Marketed by Innovent as Signifor. Retail pricing is approximately ¥2,000 to ¥2,800 per month (roughly US$275 to US$390 at 2026 exchange rates).

United States. Eli Lilly holds the ex-China license and is expected to file the New Drug Application with the FDA in 2027, using a combination of Innovent’s Chinese Phase 3 data and a bridging or confirmatory US trial. A standard 10-month FDA review would put the earliest realistic approval in late 2028, with commercial pharmacy availability in 2028 to 2029. Any earlier date is speculation.

European Union and United Kingdom. No regulatory filing has been submitted as of publication. EMA and MHRA timelines will follow the FDA filing by 12 to 24 months.

Mazdutide is not available through US telehealth channels, is not compoundable under 503A / 503B rules (no drug-shortage listing, no approved active ingredient), and is not covered by any US insurance plan because it is not yet FDA-approved.

Where mazdutide will fit in the US market when approved

Three patient profiles are the most likely first-line candidates once mazdutide reaches US pharmacies.

What mazdutide does not do

Explicit list, because the noise around next-generation drugs consistently overstates what a China approval means for a US patient:

• Not FDA-approved. Not now, not in 2027, and realistically not until 2028 to 2029.
• Not compoundable. No drug-shortage listing, no legal 503A / 503B pathway, no US pharmacy access to the active pharmaceutical ingredient.
• Not covered by US insurance. Coverage requires FDA approval as a first condition.
• Not head-to-head against tirzepatide or retatrutide. No direct comparison trial exists. Cross-trial comparisons between GLORY-1, SURMOUNT-1, and the Jastreboff 2023 retatrutide Phase 2 all use different populations and durations.
• Not backed by long-term data. Published Phase 3 data currently runs to 48 weeks. Open-label extensions are shorter than the multi-year datasets for semaglutide and tirzepatide.
• Not backed by a dedicated cardiovascular outcome trial. No SELECT-analog for mazdutide exists yet; cardiovascular benefit is inferred, not proven.

Practical read for US patients in 2026

If you are asking about mazdutide because a family member in China is on it, or because a news headline about the NMPA approval reached the US press cycle, the honest read has three parts.

First: mazdutide is genuinely a next-generation drug. The efficacy is competitive with tirzepatide on the scale and ahead of tirzepatide on the liver-fat signal. The China NMPA approval is not a token regulatory event — the pivotal Phase 3 program was well-conducted and published in NEJM and Lancet Diabetes & Endocrinology.

Second: there is no US access route today, and none will exist until at least 2028. Importing Signifor from a Chinese pharmacy is not a workaround — the FDA personal-use import exception does not apply to a domestically approved obesity drug (approved in China, unapproved in the US), and quality control, cold-chain integrity, and sterility of gray-market Signifor arriving through international shippers is not verifiable. Any US-marketed product labeled “mazdutide” is either counterfeit or an unrelated peptide.

Third: the nearest US-available options with meaningful weight loss are already on pharmacy shelves. Tirzepatide (Zepbound) is the higher-magnitude option (roughly 20.9 percent in SURMOUNT-1); semaglutide (Wegovy) is the longer-track-record option with SELECT cardiovascular data. For the pipeline drug closest to US filing, see orforglipron for weight loss. For the full pipeline map, see next generation weight loss drugs.

The correct action for a US patient who is a candidate for GLP-1 pharmacotherapy is to start on an FDA-approved option now if clinically appropriate, and to switch or add mazdutide when — and only when — it reaches US pharmacies through the legitimate FDA channel.