Tolinapant

Phase 1Small molecule

Tolinapant is one of 38 small molecule programs targeting Head and Neck Carcinoma of Unknown Primary. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Head and Neck Carcinoma of Unknown PrimaryActive, not recruiting

Rectum CancerRecruiting

Head and Neck Carcinoma of Unknown PrimaryPhase 1

Active, not recruiting

Rectum CancerPhase 1

Recruiting

Competition

Competitive Landscape

35 competitors in Rectum Cancer

#DrugCompanyPhaseTrials

Eloxatin

Elunate

Bayer Aspirin

Crestor

Stivarga

Koselugo

Rydapt

Viagra

VViatris Specialty LLC

Approved

—9

Wellcovorin

GGlaxo Dba Glaxosmithkline

Approved

—10

Rapamune

PPrism Pharmaceuticals

Approved

—

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

Timeline

Expected Milestones

Q3 2027

Phase 1Active, not recruiting

Head and Neck Carcinoma of Unknown Primary

NCT05245682

Q1 2029

Phase 1Recruiting

Rectum Cancer

NCT05912075

Clinical

Trials by Indication[1]

Rectum Cancer1 trial

Preoperative Radiotherapy And ASTX660 in Rectum Cancer

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 1·NCT05912075·78 enrolled

Breast Cancer1 trial

Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Eribulin) for Treatment of Advanced Triple Negative Breast Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT06590558

Ovarian Cancer1 trial

Testing the Addition of ASTX660 (Tolinapant) to the Usual Chemotherapy Treatment (Paclitaxel With or Without Bevacizumab) in Patients With Recurrent Ovarian Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT06393751

Head and Neck Carcinoma of Unknown Primary1 trial

Early-Phase Open-label Study of Tolinapant and Radiation in Cisplatin-Ineligible Patients With Previously Untreated, Locally Advanced Head and Neck Cancer

Active, not recruiting·EEmory University·Phase 1·NCT05245682·10 enrolled

Relapsed/Refractory Peripheral T-cell Lymphoma1 trial

A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma

Terminated· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 1·NCT05403450·33 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Tolinapant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tolinapant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tolinapant. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Taiho Oncology, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: Taiho Oncology, Inc.

Tolinapant

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q1 2029

Trials by Indication[1]

Rectum Cancer1 trial

Breast Cancer1 trial

Ovarian Cancer1 trial

Head and Neck Carcinoma of Unknown Primary1 trial

Relapsed/Refractory Peripheral T-cell Lymphoma1 trial

References

Drug Info

Quick Facts

Related News