Valemetostat (DS-3201) Clinical Trials

Size	Price	Qty
5mg	USD 270
25mg	USD 897

Clinical Trials

Valemetostat (DS-3201) is currently being evaluated across numerous Phase 1 and Phase 2 clinical trials for various hematologic malignancies—such as peripheral T-cell lymphoma, adult T-cell leukemia/lymphoma, and acute leukemias—as well as advanced solid tumors. Sponsored by industry leaders like Daiichi Sankyo alongside academic and governmental institutions, these studies encompass recruitment statuses ranging from active recruiting and not yet recruiting to completed, active not recruiting, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07303387	RECRUITING	Solid Tumor Malignancies; Clear Cell Endometrial Carcinoma; Ovarian Cancer	Gustave Roussy, Cancer Campus, Grand Paris	2026-03-05	PHASE2
NCT05633979	ACTIVE_NOT_RECRUITING	Breast Cancer	M.D. Anderson Cancer Center	2023-02-09	PHASE1
NCT06632977	RECRUITING	Castration-Resistant Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8	Alliance for Clinical Trials in Oncology	2025-02-06	PHASE2
NCT06244485	ACTIVE_NOT_RECRUITING	Advanced Solid Tumor	Daiichi Sankyo	2024-02-16	PHASE1
NCT06644768	ACTIVE_NOT_RECRUITING	Non-small Cell Lung Cancer; Lung Cancer	Daiichi Sankyo	2024-10-30	PHASE1; PHASE2
NCT07244341	RECRUITING	Metastatic Castration-resistant Prostate Cancer	Daiichi Sankyo	2025-12-03	PHASE1
NCT06294548	RECRUITING	Hepatocellular Carcinoma	University of Alabama at Birmingham	2025-07-29	PHASE1; PHASE2
NCT05683171	ACTIVE_NOT_RECRUITING	Lymphoma	M.D. Anderson Cancer Center	2023-05-19	PHASE1; PHASE2
NCT03930953	ACTIVE_NOT_RECRUITING	Lymphoma, Non-Hodgkin	Celgene	2019-05-20	PHASE1; PHASE2
NCT06807632	RECRUITING	Extensive-stage Small-cell Lung Cancer	Memorial Sloan Kettering Cancer Center	2025-01-29	PHASE1
NCT04388852	ACTIVE_NOT_RECRUITING	Aggressive Variant Prostate Carcinoma; Castration-Resistant Prostate Carcinoma; Metastatic Clear Cell Renal Cell Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Prostate Carcinoma; Metastatic Urothelial Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8	M.D. Anderson Cancer Center	2020-08-20	PHASE1
NCT05879484	WITHDRAWN	Sinonasal Cancer; Squamous Non-small Cell Lung Cancer; Lung Cancer; Head and Neck Squamous Cell Carcinoma; Head and Neck Carcnimona; Head and Neck Cancer	National Cancer Institute (NCI)	2025-07-09	PHASE1; PHASE2
NCT04842877	ACTIVE_NOT_RECRUITING	Lymphoma, B-Cell	The Lymphoma Academic Research Organisation	2021-06-11	PHASE2
NCT05879484	Not yet recruiting	Sinonasal Cancer\|Squamous Non-small Cell Lung Cancer\|Lung Cancer\|Head and Neck Squamous Cell Carcinoma\|Head and Neck Carcnimona\|Head and Neck Cancer	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2024-05-15	Phase 1\|Phase 2
NCT06244485	Recruiting	Advanced Solid Tumor	Daiichi Sankyo	2024-02-16	Phase 1
NCT04703192	ACTIVE_NOT_RECRUITING	Relapsed/Refractory Peripheral T-Cell Lymphoma; Adult T Cell Leukemia/Lymphoma	Daiichi Sankyo	2021-06-03	PHASE2
NCT02732275	ACTIVE_NOT_RECRUITING	Lymphoma, Malignant; Non-hodgkin Lymphoma	Daiichi Sankyo Co., Ltd.	2016-03-31	PHASE1
NCT04842877	Active not recruiting	Lymphoma B-Cell	The Lymphoma Academic Research Organisation\|Daiichi Sankyo	2021-06-11	Phase 2
NCT04703192	Active not recruiting	Relapsed/Refractory Peripheral T-Cell Lymphoma\|Adult T Cell Leukemia/Lymphoma	Daiichi Sankyo	2021-06-03	Phase 2
NCT04102150	COMPLETED	Adult T-cell Leukemia/Lymphoma	Daiichi Sankyo Co., Ltd.	2019-11-21	PHASE2
NCT04276662	Completed	Hepatic Impairment	Daiichi Sankyo	2019-11-21	Phase 1
NCT03110354	Terminated	Leukemia Myeloid Acute\|Leukemia Lymphocytic Acute	Daiichi Sankyo	2017-04-05	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-04-21)

Check the Valemetostat (DS-3201) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Valemetostat functions as a selective dual inhibitor of enhancer of zeste homolog 1 and 2 (EZH1/2), blocking histone methyltransferase catalytic activity and decreasing trimethylation of histone H3 at lysine 27 to reactivate epigenetically silenced tumor suppressor genes and halt oncogenic proliferation. Consequently, this target suppression induces apoptosis and inhibits tumor growth, providing a clear pharmacological basis for its clinical evaluation in hematologic malignancies such as peripheral T-cell lymphoma and B-cell lymphoma, as well as solid tumors including head and neck squamous cell carcinoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).