Mazdutide (IBI362 / LY3305677)
GLP-1/glucagon dual agonist (oxyntomodulin analog). NMPA-approved in China for weight management (Jun 2025) and glycemic control (Sep 2025). First GLP-1 class compound to beat semaglutide head-to-head on a combined T2D + weight endpoint (DREAMS-3).
This compound sits in research-grey territory. The caveats below carry more weight than for FDA-approved entries — read them.
Innovent Biologics (China), originally licensed from Eli Lilly. Oxyntomodulin is a natural gut peptide with endogenous GLP-1R + GCGR co-agonist activity — mazdutide is a long-acting engineered version. DREAMS Phase 3 program in *Nature* (back-to-back): DREAMS-3 (T2D + obesity, head-to-head vs semaglutide 1 mg, 32 weeks): 48.0% of mazdutide participants achieved HbA1c <7% AND ≥10% weight loss vs 21.0% semaglutide. GLORY-1 (obesity, *NEJM* May 2025): weight-loss data published. NMPA-approved for both indications in China 2025. NOT FDA-approved. China NMPA approval ≠ FDA recognition — explicitly relevant for US users.
JURISDICTION CRITICAL: NMPA-approved in China ≠ available in the US or Mexico. Framing mazdutide as 'approved' in Stack without the China-only qualifier would actively mislead US users. The head-to-head vs semaglutide superiority data (DREAMS-3) is real but from a 32-week trial in a predominantly Chinese T2D + obesity cohort — generalizability to US/LATAM non-T2D obese cohort is not established. Innovent Biologics is a smaller company with different bias profile than Lilly/Novo — funding pressure is real and should be flagged.
External links to PubMed searches, ClinicalTrials.gov, and FDA materials. We do not host papers — we point at canonical sources.
NMPA-approved in China for weight management (Jun 2025) + glycemic control (Sep 2025). NOT FDA-approved. China NMPA approval does not constitute FDA recognition. US importation of unapproved foreign drugs violates FDCA §801. Mexico COFEPRIS magistral path not available (not on magistral compounding list). US access = clinical trial enrollment only.
Pre-filled with this compound's published dose range: 3–9 mg once weekly (Phase 3 dose range — China NMPA approved; FDA NOT approved) · once weekly subcutaneous — NMPA-approved in China; not FDA-approved; no US prescribing path
Draw volume exceeds 100 units (1 mL). Either reduce dose or split into multiple injections.
Calculator is a discussion tool. Verify reconstitution + dosing with a qualified provider. Stack is not a prescription source. Use sterile technique and inspect every vial.
Distilled themes from named communities — Reddit threads, forums, creator commentary. Not direct quotes; not clinical evidence. Useful for calibrating expectations against what real self-experimenters report.
The DREAMS-3 head-to-head superiority vs semaglutide travels widely in LATAM biohacker communities — 'beats Ozempic' framing spreads fast, often without the T2D cohort / 32-week / China caveat. Stack's bilingual coverage with the full context is the honest counter-signal. NMPA approval generates interest but the FDA-not-recognized framing is often missing in secondary sources.