Survodutide: Peptide Profile, CAS & Properties
CAS 2805997-46-8 · 4231.69 g/mol
Survodutide (BI 456906, CAS 2805997-46-8) is a 29-amino-acid acylated peptide of the GLP-1 / glucagon dual receptor agonist class, molecular formula C192H289N47O61 (~4231.69 g/mol). It is investigational and in Phase 3 clinical development for obesity and MASH, not yet approved. This page provides reference information on Survodutide.
- CAS Number
- 2805997-46-8
- Molecular Formula
- C192H289N47O61
- Molecular Weight
- 4231.69 g/mol
- Drug Class
- GLP-1 / glucagon dual receptor agonist
What is Survodutide?
Survodutide (development code BI 456906) is an investigational dual agonist of the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP-1R). It is a 29-amino-acid linear synthetic peptide conjugated to a C18 fatty di-acid moiety through a hydrophilic linker at a lysine residue, a structural design that promotes albumin binding and resistance to enzymatic degradation to support once-weekly dosing. Co-activation of the GLP-1 and glucagon receptors is intended to combine appetite reduction and improved glycaemic control with increased energy expenditure.
As a peptide compound, survodutide (CAS 2805997-46-8, molecular formula C192H289N47O61, ~4231.69 g/mol) is characterised as a lyophilised powder. It is being studied in late-stage clinical trials for obesity and for metabolic dysfunction-associated steatohepatitis (MASH/NASH), and is currently investigational — it is not yet approved by the FDA, EMA or other major regulators, and no efficacy or therapeutic claims are made here.
How Survodutide Is Produced & Characterised
Survodutide is a synthetically demanding acylated peptide: the lipid side-chain conjugation at the lysine residue and the 29-mer length create opportunities for deletion sequences, diastereomers and incomplete acylation that must be tightly controlled. For peptides of this class, the established industry approach is optimised Fmoc solid-phase peptide synthesis (SPPS) with controlled side-chain conjugation, followed by purification on preparative dynamic axial compression (DAC) HPLC columns to resolve the target sequence sharply from closely related impurities.
Analytical characterisation typically combines UPLC/HPLC for purity with LC-MS impurity profiling to confirm the sequence and minor structural variants, and the purified material is lyophilised to a stable, uniform powder. This reference describes the general production and analytical methods associated with acylated peptides of this type and does not represent any specific manufacturing activity.
Typical Quality Specifications & Impurity Control
For acylated peptides of this class, batches are generally released against a defined specification accompanied by a Certificate of Analysis (COA). Purity is typically determined by UPLC/HPLC, while the sequence and minor structural variants are confirmed by LC-MS impurity profiling; representative release purity targets are around ≥99.0%, with individual impurities controlled below 0.10%, supported by ICH Q1A(R2) long-term and accelerated stability data.
Full traceability from raw materials and resins through to final batch-release records is characteristic of regulated peptide production. Analytical methods are commonly validated to ICH Q2(R1), and water content, acetate/counter-ion content, residual solvents and peptide content are characterised. These figures are provided as general reference values for this molecule type, not as a product specification.
Regulatory & Development Context
Survodutide is investigational and in clinical development. It is in Phase 3 trials for obesity and for metabolic dysfunction-associated steatohepatitis (MASH/NASH), and is not yet approved by the FDA, EMA or other major regulators. It has received US FDA Breakthrough Therapy designation and EMA PRIME access in MASH, designations that support and expedite ongoing development but do not constitute approval; its efficacy and safety have not been established for therapeutic use.
Within the broader peptide-API field, regulated development of investigational molecules typically involves documentation such as US-DMF dossiers and CTD Module 3 CMC sections, analytical validation packages to ICH Q2(R1), and stability data to support IND/IMPD-stage filings. This information is provided as general regulatory context for the molecule and does not describe any commercial offering.
Survodutide API — Specifications
| Compound | Survodutide |
|---|---|
| CAS Number | 2805997-46-8 |
| Molecular Formula | C192H289N47O61 |
| Molecular Weight | 4231.69 g/mol |
| Sequence | 29 amino acids, acylated (C18 di-acid side chain) |
| Drug Class | GLP-1 / glucagon dual receptor agonist |
| Appearance | White to off-white lyophilised powder |
| Typical Purity (HPLC) | ≥ 99.0% (single impurity < 0.10%) |
| Synthesis Route | Fmoc SPPS + DAC prep-HPLC purification |
| Form | Lyophilised powder |
| Storage | Store at -20°C, protected from light & moisture |
| Regulatory Status | Investigational — Phase 3; not approved by FDA/EMA |
Reference data only — WinHyCare neither supplies nor manufactures this compound; see our Semaglutide API for the product we supply. Regulatory status: Investigational; in clinical development (Phase 3) and not yet approved by the FDA, EMA or other major regulators. It has received US FDA Breakthrough Therapy designation and EMA PRIME access in MASH, but its efficacy and safety have not been established for therapeutic use.
Survodutide API — Frequently Asked Questions
What is Survodutide?
Survodutide (development code BI 456906) is an investigational synthetic peptide that acts as a dual agonist of the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP-1R). It is a 29-amino-acid peptide acylated with a C18 fatty di-acid side chain, designed for albumin binding and an extended half-life.
What is the CAS number and molecular weight of Survodutide?
Survodutide's CAS number is 2805997-46-8, its molecular formula is C192H289N47O61, and its molecular weight is approximately 4231.69 g/mol.
What class of peptide is Survodutide?
Survodutide belongs to the GLP-1 & incretin multi-agonist class — specifically a GLP-1 / glucagon dual receptor agonist. Co-activation of both receptors is intended to combine appetite reduction and improved glycaemic control with increased energy expenditure.
Is Survodutide approved by the FDA or EMA?
No. Survodutide is investigational and in clinical development (Phase 3) for obesity and MASH (NASH); it is not yet approved by the FDA, EMA or other major regulators. It has received US FDA Breakthrough Therapy designation and EMA PRIME access in MASH, but its efficacy and safety have not been established for therapeutic use.
What is Survodutide being studied for?
Survodutide is being studied in late-stage (Phase 3) clinical trials for obesity and for metabolic dysfunction-associated steatohepatitis (MASH/NASH). As an investigational molecule, no efficacy or therapeutic claims are established.
How is Survodutide produced?
Acylated peptides of this class are generally 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 describes the general industry approach rather than any specific manufacturing activity.
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Technical Reference Page
WinHyCare neither supplies nor manufactures Survodutide; this page is provided as a technical reference. The peptide API we supply is Semaglutide.