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ONO Pharmaceutical Co Ltd (JP:4528)
:4528
Tirabrutinib
Primary Central Nervous System Lymphoma (Pcnsl)
Phase I
Recruiting
A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants
Aug 31, 2025
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Rituximab, Temozolomide, Tirabrutinib
Relapsed/Refractory Primary Central Nervous System Lymphoma
Phase III
Not Yet Recruiting
Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Jul 29, 2025
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Bevacizumab, Oxaliplatin, Leucovorin, 5-Fluorouracil, Ono-4578, Opdivo®
Colorectal Cancer
Phase II
Not Yet Recruiting
A 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 in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
Apr 21, 2025
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Ono-4538
Richter's Transformation
Phase II
Recruiting
ONO-4538 Study in Patients With Richter's Transformation
Apr 13, 2025
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Ono-2020
Alzheimer Disease
Phase II
Recruiting
A Study of ONO-2020 in Participants With Mild to Moderate Alzheimer's Disease
Mar 02, 2025
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Ono-7428
Solid Tumor, Nsclc
Phase I
Recruiting
A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
Jan 29, 2025
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Ono-1110
Social Anxiety Disorder (Sad)
Phase II
Recruiting
A Study of ONO-1110 in Patients With Social Anxiety Disorder
Jan 28, 2025
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Ono-2020
Agitation Associated With Alzheimer's Disease Dementia
Phase II
Recruiting
A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
Jan 27, 2025
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Ono-1110
Major Depressive Disorder (Mdd
Phase II
Recruiting
A Study of ONO-1110 in Patients With Major Depressive Disorder
Jan 19, 2025
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Ono-1110
Fibromyalgia
Phase II
Recruiting
A Clinical Study of ONO-1110 in Patients With Fibromyalgia
Dec 22, 2024
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does ONO Pharmaceutical Co Ltd (4528) have in its pipeline
4528 is currently developing the following drugs: Tirabrutinib, Rituximab, Temozolomide, Tirabrutinib, Bevacizumab, Oxaliplatin, Leucovorin, 5-Fluorouracil, Ono-4578, Opdivo®. These drug candidates are in various stages of clinical development as the company works toward FDA approval.