Drug Profile

Valemetostat - Daiichi Sankyo

Alternative Names: DS-3201; DS-3201b; EZHARMIA; Valemetostat tosilate; valemetostat tosylate

Latest Information Update: 28 Feb 2025

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At a glance

Originator Daiichi Sankyo Inc
Developer CALYM Carnot Institute; Daiichi Sankyo Inc; Lymphoma Academic Research Organisation; Lymphoma Study Association; University of Texas M. D. Anderson Cancer Center
Class Amides; Amines; Antineoplastics; Benzodioxoles; Chlorinated hydrocarbons; Cyclohexanes; Pyridones; Small molecules
Mechanism of Action Enhancer of zeste homolog 2 protein inhibitors; EZH1 protein inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Adult T-cell leukaemia-lymphoma; Peripheral T-cell lymphoma
New Molecular Entity Yes

Marketed Adult T-cell leukaemia-lymphoma; Peripheral T-cell lymphoma
Phase II B-cell lymphoma
Phase I/II Non-small cell lung cancer; Small cell lung cancer
Phase I Solid tumours
No development reported Acute myeloid leukaemia; Diffuse large B cell lymphoma; Non-Hodgkin's lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma; Prostate cancer; Renal cell carcinoma; Urogenital cancer

07 Dec 2024 Efficacy data from the phase II VALENTINE-PTCL01 trial in Peripheral T-cell lymphoma presented at the 66th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2024)
07 Dec 2024 Primary adverse events and efficacy data from a phase II Valym trial in B-cell lymphoma presented at the 66^th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2024)
30 Oct 2024 Phase-I/II clinical trials in Non-small cell lung cancer (Late-stage disease, Metastatic disease, Combination therapy, First-line therapy) in Japan, South Korea, China (PO) (Daiichi Sankyo pipeline, March 2025)(NCT06644768)

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