Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Valemetostat Tosylate, the pharmaceutical salt form of valemetostat and a selective dual inhibitor of enhancer of zeste homolog 1 (EZH1) and enhancer of zeste homolog 2 (EZH2).
Valemetostat Tosylate is identified by CAS No. 1809336-93-3, molecular formula C26H34ClN3O4·C7H8O3S, and molecular weight 660.22 g/mol. The FDA GSRS identifies Valemetostat Tosylate as a 1:1 salt of the active moiety valemetostat and p-toluenesulfonic acid (tosylate).
Valemetostat, also known as DS-3201 / DS-3201b, is a small-molecule epigenetic anticancer agent that inhibits the enzymatic activity of EZH1 and EZH2. These enzymes are involved in histone methylation and regulation of gene expression.
Inhibition of EZH1/EZH2 reduces methylation of histone H3 at lysine 27 (H3K27), affecting transcriptional regulation and cancer-cell proliferation. PMDA describes valemetostat as a low-molecular-weight compound with inhibitory activity against EZH1/2.
The pharmaceutical product Ezharmia was approved in Japan in 2022. PMDA identifies the active ingredient as Valemetostat Tosilate and reports tablet strengths equivalent to 50 mg or 100 mg of valemetostat.
The FDA GSRS record confirms CAS 1809336-93-3, molecular weight 660.22, the C26H34ClN3O4·C7H8O3S composition, and three defined stereocenters.
Valemetostat Tosylate is relevant to pharmaceutical applications involving:
PMDA's 2022 review identifies the approved Japanese indication as relapsed or refractory adult T-cell leukemia-lymphoma. The FDA GSRS record also associates valemetostat with an orphan-drug designation for treatment of peripheral T-cell lymphoma.
Valemetostat inhibits both EZH1 and EZH2, enzymes belonging to the histone lysine methyltransferase system.
EZH1 and EZH2 participate in regulation of chromatin structure and gene expression through histone H3 lysine-27 methylation. By inhibiting these enzymes, valemetostat decreases EZH1/EZH2-mediated methylation and can alter transcriptional programs associated with malignant cell growth.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies requiring Valemetostat Tosylate API for pharmaceutical development, analytical research and oncology formulation applications.
As a Valemetostat Tosylate API manufacturer and supplier in India, Swapnroop focuses on appropriate control of:
Valemetostat Tosylate should be stored in suitable pharmaceutical packaging under controlled environmental conditions according to the validated API specification and stability data.
PMDA describes the drug substance as a white to pale yellow-white powder and reports that characterization included solubility, hygroscopicity, melting point, acid dissociation constant and distribution coefficient.
Typical pharmaceutical documentation may include:
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical customers seeking Valemetostat Tosylate API for oncology and EZH1/EZH2 inhibitor development, with emphasis on chemical identity, stereochemical integrity, impurity control and appropriate pharmaceutical documentation.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |