ONO-4538

Phase 3Small molecule

Ono Pharmaceutical Co. Ltd

ONO-4538 is one of 70 small molecule programs targeting Gastric Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastric CancerCompleted

Advanced or Metastatic Solid TumorsActive, not recruiting

Richter's TransformationRecruiting

Rhabdoid TumorRecruiting

Gastric CancerPhase 3

Completed

Advanced or Metastatic Solid TumorsPhase 1

Active, not recruiting

Richter's TransformationPhase 2

Recruiting

Rhabdoid TumorPhase 2

Recruiting

Competition

Competitive Landscape

181 competitors in Gastric Cancer

#DrugCompanyPhaseTrials

Taxol

Teva

Phase 3

44 2

Opdivo

Bristol-Myers Squibb

Phase 3

24 3

Camptosar

Pfizer

Phase 3

23 4

Keytruda

Merck & Co.

Phase 3

20 5

Xeloda

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

90 6

Taxotere

AAvyxa

Phase 3

45 7

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

55 8

Abraxane

Bristol-Myers Squibb

Phase 3

11 9

Beyfortus

Cyramza

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

Timeline

Expected Milestones

Q2 2027

Phase 3Active, not recruiting

Gastric Cancer

NCT05144854

Phase 1Active, not recruiting

Metastatic Pancreatic Cancer

NCT06532344

Q4 2027

Phase 1Active, not recruiting

Colorectal Cancer

NCT06547385

Phase 2Recruiting

Pan-Tumor

NCT04566380

Phase 1Active, not recruiting

Unresectable Colorectal Cancer

NCT06540261

Q1 2028

Phase 1Active, not recruiting

Advanced or Metastatic Solid Tumors

NCT03155061

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT02582125·53 enrolled

ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT02175017·104 enrolled

Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 3·NCT03117049·550 enrolled

Show 1 more trial

Phase 1 Study of ONO-4578 Given as Combinations of ONO-4578, ONO-4538, Docetaxel and Ramucirumab in Subjects With Metastatic Non-small Cell Lung Cancer Who Have Had Disease Progression During or After One Prior First-line Anti-PD-(L) 1 Antibody and Platinum-based Chemotherapy for Advanced/Metastatic Disease

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06542731·42 enrolled

Gastric Cancer3 trials

Study of ONO-4538 in Gastric Cancer

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2/3·NCT02746796·680 enrolled

Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 3·NCT02267343·493 enrolled

A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 3·NCT05144854·626 enrolled

Solid Tumor2 trials

ONO-4538 Phase I Study in Patients With Solid Tumor

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT02261298·18 enrolled

ONO-4538 Phase I Study in Patients With Solid Tumor

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT02261285·18 enrolled

Metastatic Pancreatic Cancer2 trials

An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06532344·32 enrolled

A PhaseⅠStudy to Examine Tolerability and Safety of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and Safety of ONO-7475 in Combination With GnP in Patients With Metastatic Pancreatic Cancer as First-line Treatment

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06532331·87 enrolled

Richter's Transformation1 trial

ONO-4538 Study in Patients With Richter's Transformation

Recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT06936943·14 enrolled

8 more indications

Pancreatic Cancer1 trial

An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06538207·46 enrolled

Advanced Malignant Solid Tumors1 trial

ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT00836888·17 enrolled

Patients With Solid Tumors1 trial

Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors

Terminated· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06535009·25 enrolled

Colorectal Cancer1 trial

ONO-4578 Phase I Study An Open-label, Uncontrolled Study of First-line Combination Therapy of ONO-4578 and ONO-4538 With Standard Therapy XELOX Plus Bevacizumab or FOLFOX Plus Bevacizumab in Patients With Unresectable, Advanced or Recurrent Colorectal Cancer

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06547385·40 enrolled

Pan-tumor1 trial

A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination With Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98)

Recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT04566380·70 enrolled

Unresectable Colorectal Cancer1 trial

An Open-label, Uncontrolled Study of ONO-7913, ONO-4538 and the Standard of Care FOLFOX in Combination With Bevacizumab or Cetuximab as First-line Treatment in Patients With Unresectable Advanced or Recurrent Colorectal Cancer

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06540261·65 enrolled

Advanced or Metastatic Solid Tumors1 trial

Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT03155061·183 enrolled

Rhabdoid Tumor1 trial

A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor

Recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT06622941·23 enrolled

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for ONO-4538. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ONO-4538 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ONO-4538. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Ono Pharmaceutical Co. Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Ono Pharmaceutical Co. Ltd

ONO-4538

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

Gastric Cancer3 trials

Solid Tumor2 trials

Metastatic Pancreatic Cancer2 trials

Richter's Transformation1 trial

Pancreatic Cancer1 trial

Advanced Malignant Solid Tumors1 trial

Patients With Solid Tumors1 trial

Colorectal Cancer1 trial

Pan-tumor1 trial

Unresectable Colorectal Cancer1 trial

Advanced or Metastatic Solid Tumors1 trial

Rhabdoid Tumor1 trial

References

Drug Info

Quick Facts

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