How is mazdutide dosed?
Mazdutide has an approved label in China — its brand name is Xinermei (信尔美) — but no FDA approval. This page reads the NMPA label’s own dosing schedule directly, the same way Prof. Peptide reads FDA labels for US-approved brands, alongside the Phase 3 GLORY trials that support it.
Topic: Reading mazdutide’s Chinese NMPA label directly, since no FDA label exists
Audience: Anyone comparing a mazdutide dose figure against its actual label or trial source
Reading time: 8–10 minutes
Approved in China — NOT approved in the US
Mazdutide has not been approved by the FDA, EMA, or any regulatory body outside China. It has been approved by China’s National Medical Products Administration (NMPA) under the brand name Xinermei, for chronic weight management and for glycemic control in type 2 diabetes. This page reads that Chinese label as its primary source — the same way Prof. Peptide reads FDA labels for approved US brands — and states plainly, throughout, that no US approval exists.
On this page
What mazdutide is, and where it’s approved
Mazdutide is a glucagon-like peptide-1 (GLP-1) and glucagon receptor (GCG) dual agonist developed by Innovent Biologics. It is approved in China under two separate NMPA labels, both under the brand name Xinermei (信尔美): one for chronic weight management, approved per the label’s own 核准日期 (approval date) field of June 24, 2025 (approval numbers 国药准字H20250036, H20250037, and H20250038 for the 2 mg, 4 mg, and 6 mg strengths respectively); and a second for glycemic control in adults with type 2 diabetes, approved September 16, 2025. Innovent’s own press releases state June 27, 2025 and September 19, 2025 for the two approvals — close to, but not identical to, the labels’ own dates, which this page reports as primary.
Outside China, mazdutide has no approved product and no FDA or EMA filing decision. The mazdutide profile covers the mechanism and broader research areas in more depth; this page exists specifically to read the NMPA label’s own dosing schedule and the GLORY trial doses side by side.
What the NMPA label specifies
The table below is mazdutide’s recommended dosage as stated in the 用法用量 (Dosage and Administration) section of the weight-management NMPA package insert, read directly from the manufacturer’s own published PDF. The type 2 diabetes label carries the identical titration table.
| Step | Dosage | As specified by the label |
|---|---|---|
| Starting dose | 2 mg once weekly | Weeks 1–4 (titration starting dose). |
| First increase | 4 mg once weekly | Weeks 5–8. |
| Maintenance | 4 mg or 6 mg once weekly (recommended) | Week 9 onward — 6 mg if further weight or glycemic improvement is needed and 4 mg is tolerated; 4 mg may be used as maintenance if 6 mg is not tolerated. |
The label states a four-tier missed-dose rule (如发生遗漏用药), based on how late the dose is relative to the next scheduled one: missed by up to 2 days (within 9 days of the next dose) — take it on the original schedule; missed by 2 to 7 days (within 2 to 14 days of the next dose) — take the missed dose as soon as possible and recalculate the weekly schedule from that date; missed by 7 to 21 days (14 to 28 days from the next dose) — reduce to the starting dose; missed by more than 21 days (more than 28 days from the next dose) — reduce to the starting dose and restart the full titration table.
Both labels carry the same boxed warning (警告) found on FDA-approved GLP-1-class labels: thyroid C-cell tumor risk, based on rodent studies, with human relevance undetermined, and contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Dosage forms and strengths (规格) list pre-filled auto-injector pens at 2 mg, 4 mg, and 6 mg per 0.5 mL injection. The Prof. Peptide dosage calculator converts between milligram figures and syringe units for a given reconstitution; it performs the arithmetic and does not set a schedule.
What the trials administered
Two trials underlie the NMPA weight-management approval and the label’s dosing table: GLORY-1, which supplies the 4 mg and 6 mg doses the label recommends, and GLORY-2, which tested a higher 9 mg dose not currently part of the approved label. Both are graded against Prof. Peptide’s standing citation convention — a claim is attributed when it resolves to a named, checkable source. Both grade as attributed, peer-reviewed publications.
GLORY-1 — Phase 3, Obesity/Overweight
NCT05607680Ji L, Jiang H, Bi Y, et al. N Engl J Med. 2025;392(22):2215–2225.
Design: Phase 3, double-blind, placebo-controlled trial in China, in adults aged 18–75 with a BMI of 28 or higher, or 24 to under 28 with at least one weight-related coexisting condition. Coprimary endpoints (percentage body-weight change and ≥5% weight reduction at week 32) used a treatment-policy estimand.
Arms: 610 participants randomized 1:1:1 to once-weekly subcutaneous mazdutide 4 mg, mazdutide 6 mg, or placebo, for 48 weeks.
Endpoint reported: Body-weight change at week 48: −11.00% (4 mg) and −14.01% (6 mg), versus +0.30% (placebo). At week 32: −10.09% (4 mg) and −12.55% (6 mg) versus +0.45% (placebo); 73.9%, 82.0%, and 10.5% respectively achieved ≥5% weight reduction (P<0.001 for all comparisons with placebo).
Adverse events reported at these doses: The most frequently reported adverse events were gastrointestinal, mostly mild to moderate. Adverse events leading to discontinuation: 1.5% (4 mg), 0.5% (6 mg), 1.0% (placebo).
Attributed — published in a peer-reviewed journal (NEJM, 2025), registered with a checkable NCT number, phase/N independently confirmed against the ClinicalTrials.gov record. This is the trial underlying the NMPA's weight-management approval.
GLORY-2 — Phase 3, Moderate-to-Severe Obesity
NCT06164873Gao L, Jiang H, Cai H, et al. JAMA. 2026;336(5):377–388.
Design: Phase 3, double-blind, placebo-controlled trial in China, in adults with or without type 2 diabetes and a BMI of 30 or higher, conducted at 27 hospitals from December 2023 to November 2025. Coprimary endpoints (percentage body-weight change and ≥5% weight reduction at week 60) were analyzed in participants receiving at least one dose.
Arms: 461 participants received treatment (307 mazdutide, 154 placebo) of 462 randomized 2:1 to once-weekly subcutaneous mazdutide 9 mg or placebo, for 60 weeks.
Endpoint reported: Body-weight change at week 60: −16.65% (mazdutide) versus −1.50% (placebo), between-group difference −15.15% (95% CI −17.22 to −13.09, P<0.001). 84.3% of the mazdutide group achieved ≥5% weight reduction, versus 33.1% on placebo.
Adverse events reported at these doses: Adverse events leading to discontinuation: 2.9% (mazdutide) versus 0% (placebo). The most common adverse events were vomiting (53.1% vs. 1.3%), nausea (46.9% vs. 3.2%), and diarrhea (39.4% vs. 6.5%) — most mild to moderate.
Attributed — published in a peer-reviewed journal (JAMA, 2026), registered with a checkable NCT number, phase/N independently confirmed against the ClinicalTrials.gov record. An earlier topline press release reported different figures (−18.55%/−3.02%, N=462) before peer review; the published JAMA figures above are reported as primary, since they are the checked, final analysis.
A separate Phase 3 trial program (DREAMS-1 and DREAMS-2) underlies the type 2 diabetes indication; those trials are not given full cards here since this page’s focus is the weight-management dosing spine, but the type 2 diabetes label carries the identical titration table reported above.
Is there a community-reported dose?
Yes — but it does not match the NMPA label, which is a different finding from simply nothing being found. Every vendor or blog “mazdutide dosing protocol” page checked describes a schedule that diverges from the label’s actual 2 mg (weeks 1–4) → 4 mg (weeks 5–8) → 4 mg-or-6 mg maintenance (week 9 onward) table: some state a 1 mg starting dose, others describe a “3 mg → 6 mg → 9 mg” schedule — closer to GLORY-2’s 9 mg trial dose than to the approved label.
None of the pages checked cite the NMPA label as their source. This page reports the label’s actual schedule in the section above and flags the discrepancy here, rather than repeating either community figure as if it were the approved dose.
Compounding and research-grade mazdutide
Mazdutide has no US-approved product, so there is neither a US branded version nor a lawful US pharmacy-compounded version of one — its NMPA approval in China does not change that.
No FDA warning letter specifically naming mazdutide was found. FDA’s own warning letter on GLP-1 compounding (“GLP-1 Solution,” reference 715883, dated September 9, 2025) names retatrutide, semaglutide, and tirzepatide specifically — not mazdutide. This page instead applies section 503A’s published criteria to mazdutide directly: a bulk drug substance is eligible for compounding only if it complies with a USP or NF monograph, is a component of an FDA-approved drug, or appears on FDA’s 503A bulks list. Checked directly against FDA’s own 503A and 503B bulk drug substance list pages on the date this page was built, “mazdutide” appears on neither list, in any category. Mazdutide has no USP or NF monograph and is not a component of any FDA-approved drug. Approval by a foreign regulator, including China’s NMPA, does not satisfy any of the three 503A conditions, which turn on US regulatory status specifically.
Research-grade mazdutide, of the kind sold by the vendors Prof. Peptide tracks elsewhere on this site, is not a compounded drug product and not a branded product in the US — those categories don’t apply to it at all here. It is sold labeled for laboratory research use, not for human administration, and it is not dispensed against a prescription.
FAQ
Is mazdutide FDA-approved?
What is the NMPA-approved starting dose?
Is there a commonly reported mazdutide dosing protocol outside the NMPA label?
What is the missed-dose rule?
Does mazdutide carry a boxed warning?
Can mazdutide legally be compounded in the US the way semaglutide or tirzepatide once were?
What does Prof. Peptide's own research-grade mazdutide fall under, then?
References
- Innovent Biologics (信达生物制药苏州有限公司). 玛仕度肽注射液说明书 (Mazdutide Injection prescribing information) — weight-management indication, 核准日期 2025-06-24, 批准文号 国药准字H20250036/H20250037/H20250038. https://img.innoventbio.com/product/W10030842001.pdf
- Ji L, Jiang H, Bi Y, et al. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025;392(22):2215–2225. ClinicalTrials.gov NCT05607680. https://clinicaltrials.gov/study/NCT05607680
- Gao L, Jiang H, Cai H, 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. ClinicalTrials.gov NCT06164873. https://clinicaltrials.gov/study/NCT06164873
- U.S. Food and Drug Administration. Warning Letter: GLP-1 Solution, reference 715883, 2025-09-09 (names retatrutide, semaglutide, and tirzepatide; does not name mazdutide). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glp-1-solution-715883-09092025
- U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
- U.S. Food and Drug Administration. 503B Bulk Drug Substances List. https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list
We may earn commissions from peptide vendor affiliate links.