Valemetostat

Phase 2Small molecule

Valemetostat is one of 150 small molecule programs targeting Extensive-stage Small-cell Lung Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

149

Competitors

Pipeline

Status by Indication[3][1]

Indication

Extensive-Stage Small-Cell Lung CancerRecruiting

Hepatocellular CarcinomaRecruiting

Renal Cell CancerActive, not recruiting

Breast CancerActive, not recruiting

Prostate CancerRecruiting

LymphomaActive, not recruiting

Extensive-Stage Small-Cell Lung CancerPhase 1

Recruiting

Hepatocellular CarcinomaPreclinical

Recruiting

Renal Cell CancerPhase 1

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

Prostate CancerPhase 1

Recruiting

LymphomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Valemetostat

Bristol-Myers Squibb

Phase 2

1 2

Adenocard

Astellas

Preclinical

2 3

Voltaren

Novartis

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 8

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 9

Tianeptine

Pfizer

Preclinical

1 10

Dextromethorphan Hydrobromide

Boehringer Ingelheim

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Renal Cell Cancer

NCT04388852

Q1 2027

Phase 1Recruiting

Extensive-Stage Small-Cell Lung Cancer

NCT06807632

Q3 2027

PreclinicalActive, not recruiting

Lymphoma

NCT05683171

Q1 2028

Phase 1/2Active, not recruiting

Lymphoma

NCT03930953

Clinical

Trials by Indication[1]

Lymphoma2 trials

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT03930953·438 enrolled

A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma

Active, not recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT05683171·16 enrolled

Squamous Cell Carcinoma1 trial

Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT05879484

Renal Cell Cancer1 trial

DS3201 and Ipilimumab for the Treatment of Metastatic Prostate, Urothelial and Renal Cell Cancers

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04388852·65 enrolled

Prostate Cancer1 trial

A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07244341·60 enrolled

Hepatocellular Carcinoma1 trial

A Phase Ib/II, Dose Escalation and Dose Expansion Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in Advanced Hepatocellular Carcinoma (HCC)

Recruiting·UUniversity of Alabama at Birmingham·Preclinical·NCT06294548·45 enrolled

2 more indications

Extensive-stage Small-cell Lung Cancer1 trial

Phase I Study of Valemetostat and Atezolizumab as Maintenance Therapy for Patients With Extensive-Stage Small Cell Lung Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT06807632·24 enrolled

Breast Cancer1 trial

Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05633979·17 enrolled

Sources

References

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

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Bristol-Myers Squibb

Valemetostat

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q1 2028

Trials by Indication[1]

Lymphoma2 trials

Squamous Cell Carcinoma1 trial

Renal Cell Cancer1 trial

Prostate Cancer1 trial

Hepatocellular Carcinoma1 trial

Extensive-stage Small-cell Lung Cancer1 trial

Breast Cancer1 trial

References

Drug Info

Quick Facts

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