Mazdutide: Peptide Profile, CAS & Properties
CAS 2259884-03-0 · 4563.14 g/mol
Mazdutide (CAS 2259884-03-0) is a 39-amino-acid acylated peptide of the GLP-1 / glucagon dual receptor agonist class, an oxyntomodulin analogue studied for obesity and type 2 diabetes. Approved by China's NMPA (2025); investigational elsewhere. This page provides reference information on Mazdutide.
- CAS Number
- 2259884-03-0
- Molecular Formula
- C210H322N46O67
- Molecular Weight
- 4563.14 g/mol
- Drug Class
- GLP-1 / glucagon dual receptor agonist
What is Mazdutide?
Mazdutide is a long-acting dual agonist of the GLP-1 (glucagon-like peptide-1) receptor and the glucagon receptor (GCGR). It is a synthetic 39-amino-acid analogue of the gut hormone oxyntomodulin, modified for extended half-life: an Aib (2-aminoisobutyric acid) substitution at position 2 confers resistance to DPP-4 degradation, and acylation with a C20 (eicosanedioic) fatty di-acid attached through an AEEA-γGlu linker drives strong albumin binding, supporting once-weekly administration. By engaging both incretin and glucagon pathways, the molecule is studied for body-weight reduction together with glycaemic effects.
Mazdutide (CAS 2259884-03-0, molecular formula C210H322N46O67, ~4563.14 g/mol) is a lyophilised peptide that is formulated into injectable finished dosage forms. Its regulatory status varies by region: it has been approved by China's NMPA for chronic weight management and for glycaemic control in type 2 diabetes, while outside China it remains investigational and in late-stage clinical development — it is not yet approved by the US FDA or EMA.
How Mazdutide Is Produced & Characterised
Mazdutide is a synthetically demanding acylated peptide: the 39-mer oxyntomodulin backbone, the non-proteinogenic Aib residue and the lipid side-chain conjugation all create opportunities for deletion sequences, diastereomers and incomplete acylation. As an industry reference point, peptides of this class are typically prepared by optimised Fmoc solid-phase peptide synthesis (SPPS) with controlled side-chain conjugation, then purified on preparative dynamic axial compression (DAC) HPLC columns to resolve the target sequence from closely related impurities.
Production campaigns for this peptide class generally progress from optimisation runs through kilogram and multi-kilogram scale, finished by lyophilisation to a stable, uniform powder. Repeatable batch-to-batch consistency depends on process development, technology transfer and scale-up controls, which is why molecules such as mazdutide are commonly advanced from clinical to commercial scale through specialist contract development and production routes.
Typical Quality Specifications & Impurity Control
For an acylated peptide of this type, batches are typically released against a defined specification documented in a Certificate of Analysis. Purity is determined by UPLC/HPLC, while the sequence and minor structural variants are confirmed by LC-MS impurity profiling. Pharmaceutical-grade material commonly targets a release purity of ≥99.0%, with individual impurities controlled below 0.10%, supported by ICH Q1A(R2) long-term and accelerated stability data.
Traceability is generally maintained from raw materials and resins through to final batch-release records. Analytical methods are validated to ICH Q2(R1), and parameters such as water content, acetate/counter-ion content, residual solvents and peptide content are characterised so material is suitable for regulated formulation development.
Regulatory Context & Handling Reference
The regulatory pathway for mazdutide differs by jurisdiction. It has been approved as an active ingredient by China's NMPA — for chronic weight management and for glycaemic control in type 2 diabetes (both 2025) — while outside China it remains investigational and in late-stage clinical development, and is not yet approved by the US FDA or EMA. Where a peptide active ingredient is filed for regulated use, dossiers such as a US-DMF Type II and CTD Module 3 CMC sections, ICH Q2(R1) analytical validation packages and stability data are the standard supporting documentation referenced by finished-product submissions (IND/NDA/ANDA where applicable).
From a handling standpoint, lyophilised peptides of this class are generally packaged under controlled low-temperature conditions and transported via temperature-controlled logistics with monitoring, reflecting their sensitivity to heat, light and moisture. This page is a reference profile; it is not an offer to supply the compound.
Mazdutide API — Specifications
| Compound | Mazdutide |
|---|---|
| CAS Number | 2259884-03-0 |
| Molecular Formula | C210H322N46O67 |
| Molecular Weight | 4563.14 g/mol |
| Sequence | 39 amino acids, acylated (C20 di-acid side chain) |
| Drug Class | GLP-1 / glucagon dual receptor agonist |
| Appearance | White to off-white lyophilised powder |
| Purity (HPLC) | ≥ 99.0% (single impurity < 0.10%) |
| Synthesis Route | Fmoc SPPS + DAC prep-HPLC purification |
| Regulatory Status | Approved by China's NMPA (2025); investigational outside China (not FDA/EMA approved) |
| Storage | Typically stored at -20°C, protected from light & moisture |
| Form | White to off-white lyophilised powder |
Reference data only — WinHyCare neither supplies nor manufactures this compound; see our Semaglutide API for the product we supply. Regulatory status: Approved as an active ingredient by China's NMPA (chronic weight management, 2025; glycaemic control in type 2 diabetes, 2025). Outside China it remains investigational and in late-stage clinical development — not yet approved by the US FDA or EMA.
Mazdutide API — Frequently Asked Questions
What is Mazdutide?
Mazdutide is a long-acting dual receptor agonist that activates both the GLP-1 (glucagon-like peptide-1) receptor and the glucagon receptor (GCGR). It is a synthetic 39-amino-acid analogue of the gut hormone oxyntomodulin, engineered with an Aib substitution at position 2 and a C20 fatty di-acid side chain for an extended half-life.
What is the CAS number and molecular weight of Mazdutide?
Mazdutide's CAS number is 2259884-03-0, its molecular formula is C210H322N46O67, and its molecular weight is approximately 4563.14 g/mol. It is a 39-amino-acid oxyntomodulin analogue acylated with a C20 fatty di-acid side chain via an AEEA-γGlu linker.
Is Mazdutide approved?
Mazdutide has been approved as an active ingredient by China's NMPA for chronic weight management and for glycaemic control in type 2 diabetes (both 2025). Outside China it remains investigational and in late-stage clinical development, and is not yet approved by the US FDA or EMA.
What class of peptide is Mazdutide?
Mazdutide belongs to the GLP-1 and incretin multi-agonist class — specifically, it is a GLP-1 / glucagon dual receptor agonist. Structurally it is an acylated oxyntomodulin analogue, related to other incretin-based peptides such as tirzepatide and retatrutide.
What is Mazdutide being studied for?
By engaging both the incretin (GLP-1) and glucagon signalling pathways, Mazdutide is studied for body-weight reduction together with glycaemic effects. Its principal areas of investigation are obesity (chronic weight management) and type 2 diabetes.
How is Mazdutide produced?
Peptides of this class are typically produced by optimised Fmoc solid-phase peptide synthesis (SPPS) with controlled lipid side-chain conjugation, followed by preparative dynamic axial compression (DAC) HPLC purification and lyophilisation to a stable powder. This reflects the general production approach reported for acylated peptide active ingredients, not a supply offer.
Related Peptide APIs
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Technical Reference Page
WinHyCare neither supplies nor manufactures Mazdutide; this page is provided as a technical reference. The peptide API we supply is Semaglutide.