Valemetostat tosylate

Phase 2Small molecule

Daiichi Sankyo

Valemetostat tosylate is one of 124 small molecule programs targeting Lymphoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

123

Competitors

Pipeline

Status by Indication[3][1]

Indication

LymphomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Relapsed/refractory Peripheral T-Cell LymphomaActive, not recruiting

Efficacy and SafetyNot yet recruiting

LymphomaPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPreclinical

Active, not recruiting

Relapsed/refractory Peripheral T-Cell LymphomaPhase 2

Active, not recruiting

Efficacy and SafetyPhase 2

Not yet recruiting

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Trodelvy

Gilead

Phase 3

10 2

Verzenio

Eli Lilly

Phase 3

7 3

Aumolertinib

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Phase 3

6 4

Valemetostat tosylate

Daiichi Sankyo

Phase 2

1 5

HD204

PPrestige Biopharma Limited

Phase 3

1 6

Remeron

OOrganon and Co

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2Active, not recruiting

Relapsed/refractory Peripheral T-Cell Lymphoma

NCT04703192

Q4 2028

Phase 1Active, not recruiting

Solid Tumor

NCT06244485

Q2 2030

PreclinicalActive, not recruiting

Non-Small Cell Lung Cancer

NCT06644768

Q1 2032

Phase 2Not yet recruiting

Efficacy and Safety

NCT07303387

Clinical

Trials by Indication[1]

Adult T-Cell Leukemia/lymphoma1 trial

Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT04102150·25 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of the Valemetostat in Patients With Selected Solid Tumors.

Not yet recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT07303387·900 enrolled

Lymphoma1 trial

Study of Valemetostat Tosylate as a Single Agent in Patients With Relapse/Refractory B-cell Lymphoma

Active, not recruiting·TThe Lymphoma Academic Research Organisation·Phase 2·NCT04842877·141 enrolled

Castration-Resistant Prostate Carcinoma1 trial

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT06632977·474 enrolled

Peripheral T-Cell Lymphoma1 trial

Medical Access Program for Valemetostat Tosylate (DS 3201b) For The Treatment of Patients With Relapsed/Refractory (R/R) Peripheral T-cell Lymphoma (PTCL) Originating From Mature T Cells (Including But Not Limited to Adult T-cell Leukemia/Lymphoma [ATLL], Anaplastic Large Cell Lymphoma [ALCL], Refractory Nodal T-Follicular Helper Lymphoma [nTFHL]), Regardless of CD30 Who Have Failed on 2 or More Lines of Treatments

Available· Daiichi Sankyo logo

Daiichi Sankyo··NCT07862465

3 more indications

Solid Tumor1 trial

A Phase 1b, Multicenter, Open-Label Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT06244485·210 enrolled

Non-Small Cell Lung Cancer1 trial

A Multicenter, Randomized, Open-Label, Phase 1b/2 Trial Of Valemetostat Tosylate Plus Pembrolizumab Vs Pembrolizumab Alone in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 With Tumor Proportion Score ≥50% Without Actionable Genomic Alterations

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Preclinical·NCT06644768·137 enrolled

Relapsed/Refractory Peripheral T-cell Lymphoma1 trial

Single-arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects With Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT04703192·155 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Valemetostat tosylate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Valemetostat tosylate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Valemetostat tosylate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Daiichi Sankyo company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Daiichi Sankyo

Valemetostat tosylate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2028

Q2 2030

Q1 2032

Trials by Indication[1]

Adult T-Cell Leukemia/lymphoma1 trial

Efficacy and Safety1 trial

Lymphoma1 trial

Castration-Resistant Prostate Carcinoma1 trial

Peripheral T-Cell Lymphoma1 trial

Solid Tumor1 trial

Non-Small Cell Lung Cancer1 trial

Relapsed/Refractory Peripheral T-cell Lymphoma1 trial

References

Drug Info

Quick Facts

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