ONO-4578

Phase 2Small molecule

Ono Pharmaceutical Co. Ltd

ONO-4578 is one of 135 small molecule programs targeting Breast Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

134

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

Colorectal CancerRecruiting

Gastric CancerActive, not recruiting

Advanced or Metastatic Solid TumorsActive, not recruiting

Breast CancerPhase 1

Active, not recruiting

Colorectal CancerPhase 2

Recruiting

Gastric CancerPhase 2

Active, not recruiting

Advanced or Metastatic Solid TumorsPhase 1

Active, not recruiting

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

ONO-4578

Ono Pharmaceutical Co. Ltd

Phase 2

1 2

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 3

Ablavar

LLantheus Medical Imaging

Preclinical

2 4

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 5

Sertraline ODT

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

Preclinical

1 6

Liposomal Irinotecan and Apatinib

SSecond Affiliated Hospital, School of Medicine, Zhejiang University

Preclinical

1 7

Midazolam Premedication

YYonsei University

Preclinical

1 8

Combination NRT

UUniversity of Alabama at Birmingham

Preclinical

1 9

Calendula

OOHSU Knight Cancer Institute

Preclinical

1 10

Maxigesic

YYonsei University

Preclinical

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

Timeline

Expected Milestones

Q3 2027

Phase 2Active, not recruiting

Gastric Cancer

NCT06256328

Q4 2027

Phase 1Active, not recruiting

Colorectal Cancer

NCT06547385

Q1 2028

Phase 1Active, not recruiting

Advanced or Metastatic Solid Tumors

NCT03155061

Q4 2028

Phase 2Recruiting

Colorectal Cancer

NCT06948448

Clinical

Trials by Indication[1]

Gastric Cancer2 trials

A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With 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 2·NCT06256328·226 enrolled

A Phase 3, Randomized, Multicenter, Double-blind Study of the Efficacy and Safety of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With HER2-negative, PD-L1-Positive Advanced or Metastatic Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma

Not yet recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 3·NCT07818070·600 enrolled

Colorectal Cancer2 trials

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

A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo® in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT06948448·144 enrolled

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

Breast Cancer1 trial

ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06570031·46 enrolled

Non-Small Cell Lung Cancer1 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

1 more indication

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

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for ONO-4578. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ONO-4578 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ONO-4578. 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 2[1]
Company: Ono Pharmaceutical Co. Ltd

ONO-4578

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2028

Q4 2028

Trials by Indication[1]

Gastric Cancer2 trials

Colorectal Cancer2 trials

Pancreatic Cancer1 trial

Breast Cancer1 trial

Non-Small Cell Lung Cancer1 trial

Advanced or Metastatic Solid Tumors1 trial

References

Drug Info

Quick Facts

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