Mazdutide

Areas of active research — not promised effects

Each tag links to other compounds with research into that goal. Research use only: these are areas of study, not human-use claims.

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Mazdutide has not been approved by the FDA and no US NDA or BLA has been publicly filed as of May 2026. There is no legal pathway for human use in the United States outside of a registered clinical trial. Eli Lilly conducted a US phase 1 trial (NCT05623839, completed); however, no US phase 3 programme has been announced by Innovent Biologics. The compound is not subject to the FDA-19 Category 2 peptide compounding framework (fda19=false) because it has not been evaluated for 503A/503B bulk-drug list status — it is simply not an approved or compoundable drug in the US context.

Transparent blend · bci-1.0 · never paid-placement

Primary name

Mazdutide

Origin

Mazdutide (also designated IBI362 by developer Innovent Biologics; earlier code LY3305677 from an Eli Lilly collaboration) is a synthetic mammalian oxyntomodulin analogue. Oxyntomodulin is an endogenous post-translational product of the proglucagon gene expressed in intestinal L-cells; it possesses intrinsic agonist activity at both the GLP-1 receptor and the glucagon receptor. Mazdutide was engineered with amino-acid substitutions to improve receptor potency and a C20 fatty diacid conjugated via a hydrophilic PEG spacer to a lysine side chain to extend the half-life to approximately one week, supporting once-weekly subcutaneous administration. CAS 2259884-03-0; PubChem CID 167312357.

Registry IDs

PubChem CID

167312357

CAS

2259884-03-0

InChIKey

XRBYWQZGSZWYEJ-HMQIFOERSA-N

Molecular formula

C207H317N45O65

Molar mass

4476 g/mol

Monoisotopic

4473.2883156 Da

InChIKey

XRBYWQZGSZWYEJ-HMQIFOERSA-N

Appearance

White to off-white lyophilised powder; typical for acylated peptides of this molecular weight (~4,476 Da)

Solubility

Soluble in aqueous buffers at physiological pH; the C20 fatty diacid–PEG conjuga…

Sequence not available in current seed.

Stability: Fatty acid–PEG linker conjugation confers extended solution stability and resistance to dipeptidyl peptidase-4 (DPP-4) cleavage; degradation pathways include me

Vial sizes

null mg

Purity grades

research grade

Salt forms

Free base (primary)

• GHS hazard class on file
• PPE & spill response
• Disposal guidance
• Not-for-human-consumption posture

How much research exists, and of what maturity — never a verdict on whether it works.

Mechanism of action

• Mazdutide simultaneously engages the GLP-1 receptor (GLP-1R) and the glucagon receptor (GCGR), two class B G-protein-coupled receptors that signal predominantly through Gs/cAMP-dependent pathways
• GLP-1R activation in pancreatic beta cells potentiates glucose-dependent insulin secretion, suppresses glucagon release from alpha cells, slows gastric emptying, and signals to hypothalamic and brainstem satiety centres to reduce food intake
• GCGR activation in the liver stimulates glycogenolysis and fatty acid oxidation, elevates resting energy expenditure, and reduces hepatic lipid accumulation — effects that are largely absent with selective GLP-1R agonists
• The net result is a combined reduction in caloric intake (via appetite suppression) and increase in energy expenditure (via the glucagon arm), producing weight loss that exceeds what is attributable to GLP-1R agonism alone

Pharmacokinetics (ADME)

Half-life

Approximately 8–10 days; supports once-weekly subcutaneous dosing. A phase 1 high-dose study (16 mg) reported a half-life of approximately 8 days.

Clearance

Apparent clearance approximately 0.0368 L/h in adults with overweight or obesity. Mild renal impairment and any degree of renal impairment do not significantly alter pharmacokinetics; data for end-stage renal disease and moderate-to-severe hepatic impairment require further characterisation.

PK–PD note: Time to peak plasma concentration (Tmax) is 7–28 hours after subcutaneous injection. Mean apparent volume of distribution approximately 11.2 L. Steady-state plasma concentrations are reached after app…

Reading the evidence

• Evidence quality and gaps vary by application — see the cited grades above.
• Indexed-article counts span all evidence tiers, not only completed human trials.
• No first-party human-dosing, efficacy, or benefit claims are made here.

5 registered trials — 2 currently recruiting.

Phase 1
NCT04440345
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

COMPLETED

Phase 1
NCT05793450
Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

COMPLETED

Phase 2
NCT06862908
A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity

RECRUITING

Phase 3
NCT07083154
GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)

RECRUITING

Phase 1
NCT05623839
A Study of LY3305677 in Participants With Obesity Or Overweight

COMPLETED

Summary (literature)

Across phase 1b through phase 3 trials, the most frequently reported adverse effects are gastrointestinal: nausea, vomiting, diarrhoea, and constipation — consistent with the GLP-1R agonist class and typically mild to moderate in severity. In the GLORY-1 phase 3 study, gastrointe…

WADA status

Not specifically listed by name on the 2026 WADA Prohibited List. GLP-1 receptor agonists as a class are not currently prohibited; however, the glucagon recepto…

Dominant research route: Subcutaneous injection (once weekly)

Once-weekly subcutaneous injection studied across Phase 1b, Phase 2, and Phase 3 human trials in Chinese adults with overweight/obesity or type 2 diabetes (doses 0.05 mg up to 16 mg)

Bioavailability: Mazdutide is an acylated long-acting synthetic oxyntomodulin peptide analogue with a fatty acid side chain enabling once-weekly dosing; reported Tmax approximately 7 h and half-life reported in the range of ~7.3 to ~44.8 days (secondary citation of Phase 1 PK)

Subcutaneous is the only route of administration evaluated in human clinical trials; all registered RCTs (NCT04440345, NCT04904913, and others) administered mazdutide as once-weekly SC injection. Wikipedia lists the route of administration as 'Injection'. No intravenous, intramuscular, intraperitoneal, oral, intranasal, or topical routes have been reported in the published literature.

Animal & human figures are kept visibly separate so studied animal doses are never misread as human guidance.

Sorted A–Z by vendor — never by price

Weekly median $/mg from the live vendor crawl.

Researched storefront prices, bucketed

p25 $7.47 · median $15.00 · p75 $17.37 · 9 researched vendors

Legit, COA-backed band: $6.93–$19.33/mg.

Value rule: don't just buy the cheapest — a price under $3/mg is a red flag. Pair price with COA and independent-test grade.

Estimated cost of research (10 mg)

Vial (best researched price)

$49

Bacteriostatic water (generic estimate)

$6

Syringes / supplies (generic estimate)

$12

What each test proves — general guidance, plus this compound's researched purity data

Independent labs cited for this compound

No recalls, market withdrawals, or safety alerts specific to mazdutide (Xinermei®) were found in FDA, NMPA, or aggregator databases reviewed. The product is not FDA-approved and has no US marketed lots subject to recall.

Buyer red-flag checklist

• Not approved by the US FDA for any indication; no US clinical trials registered or completed per secondary aggregators.
• FDA Warning Letter (Dec 10, 2024) to Xcel Research LLC explicitly named 'MAZDUTIDE' as an unapproved new drug sold with human-use efficacy claims despite 'research use only' labeling.
• Falls under FDA Import Alert 66-41 (Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.) by category.
• Online 'research peptide' vendors market mazdutide with weight-loss, glucose-control, and cardiovascular-benefit claims that establish drug intent under FD&C Act section 201(g)(1).
• No independent aggregate purity or underdosing prevalence data publicly retrievable; vendor-published COAs (e.g., '>99% purity, Janoshik-tested') are unverified vendor claims, not de-identified lab aggregates.
• Counterfeit/falsified mazdutide-specific incidents were not identified in retrieved sources, but the broader GLP-1 agonist class (semaglutide/Ozempic) has documented counterfeit entries in the US supply chain, indicating class-level risk.

GMP vs research-grade: the chemistry (SPPS + HPLC + MS) is identical — the difference is the quality system.

Underdosing / mislabeling: No independent third-party lab testing aggregates (Janoshik public tests, MZ Biolabs, Finnrick) reporting quantitative underdosing prevalence for mazdutide were retrievable. A Janoshik Analytical FAQ (cited via secondary aggregator) indicates Janoshik had tested mazdutide 'a lot of it' as of June 2024, but no de-identified aggregate purity/underdosing statistics were publicly available at the time of retrieval.

• FDA Import Alert 66-41, 'Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.', authorizes DWPE of unapproved new drug products. Because mazdutide is not FDA-approved and has been marketed by US peptide vendors with human-use claims (see Xcel Research LLC warning letter), commercial/promotional shipments of mazdutide fall within the scope of this alert. Mazdutide is not individually named on the Red List in the retrieved alert text; applicability is by category (unapproved new drug).66-41
• An RUO label is not an import exemption — CBP judges actual intended use.
• Lyophilized powder is ambient-stable in transit; temperature control needed for > 7-day transit.
• US-warehouse vendors dodge import scrutiny — they cost more but ship more reliably.

Every item dated & sourced

Not identified on the WADA Prohibited List (2025/2026); mazdutide is a therapeutic peptide not listed by name. Status should be confirmed via GlobalDRO/WADA for athletic use.

No granted patents identified in current seed. Composition-of-matter coverage is limited given the peptide's synthetic origin.

• IACUC / IRB research context
• RUO buyer responsibilities & documentation
• Veterinary / alternative-use where lawful
• Jurisdiction-aware "who may lawfully obtain"

What people discuss

Reported concerns — discussion, not established effects

Reading caveats

• Self-experimenter community (non-clinical use context)
• Sourcing/vendor discussion prominent
• Small sample, early-adopter bias
• Stacking confounds attribution of effects

Manually researched from reddit— theme weights are research estimates, not live counts; aggregated & de-identified. No individual posts, quotes, or usernames are ever shown.

Relative research / market volume — populated once the activity stream is wired

Inline tooltips for lyophilized, RUO, EU/mg, SPPS, 503A and more.

Toggle plain-language ↔ scientific in the header.

• How to read a COA
• Free base vs acetate
• Understanding evidence grades

Once-weekly GLP-1/glucagon dual receptor agonist (IBI362) approved in China for obesity; NMPA-approved Apr 2026; under investigation in phase 3 globally. Approximately 39 articles are indexed (literature last scanned 2026-05-29). US regulatory status: Investigational — no FDA approval; no NDA filed in the US. Research use only.

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