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ONO Pharmaceutical Co (4528) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
Ono-4915Sjogren's DiseasePhase IINot Yet RecruitingONO-4915 in Patients With Primary Sjogren's DiseaseSep 03, 2026
Ono-7429Solid TumorsPhase IRecruitingA Study of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid TumorsAug 18, 2026
Ono-6414Ulcerative Colitis (Uc)Phase IRecruitingA Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative ColitisJul 31, 2026
Ono-4538HscPediatric Malignant Solid Tumor And Epithelioid Sarcomaphase1AndPhase2RecruitingA Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.Jul 06, 2026
Dcc-2618Gastrointestinal Stromal TumorsPhase IRecruitingStudy of DCC-2618 in Patients With GIST After at Least 3 Prior TreatmentsMay 25, 2026
Cenobamate For 12 To < 18 Year Olds, Cenobamate For 2 To < 18 Year OldsPartial EpilepsyPhase IIIRecruitingA Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year OldsMay 11, 2026
SapablursenPolycythemia VeraPhase IIIRecruitingINTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)Feb 18, 2026
TirabrutinibPrimary Central Nervous System Lymphoma (Pcnsl)Phase ICompletedA Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy ParticipantsAug 31, 2025
Rituximab, Temozolomide, TirabrutinibRelapsed/Refractory Primary Central Nervous System LymphomaPhase IIIRecruitingIGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)Jul 29, 2025
Bevacizumab, Oxaliplatin, Leucovorin, 5-Fluorouracil, Ono-4578, OpdivoColorectal CancerPhase IIRecruitingA 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 CancerApr 21, 2025

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
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 (JP:4528) have in its pipeline
ONO Pharmaceutical Co JP:4528 is currently developing the following drugs: Ono-4915, Ono-7429, Ono-6414, Ono-4538Hsc, Dcc-2618, Cenobamate For 12 To < 18 Year Olds, Cenobamate For 2 To < 18 Year Olds, Sapablursen, Tirabrutinib, Rituximab, Temozolomide, Tirabrutinib, Bevacizumab, Oxaliplatin, Leucovorin, 5-Fluorouracil, Ono-4578, Opdivo, Ono-4538, Ono-2020, Ono-7428, Ono-1110, Ono-4059, Ono-7018, Cenobamate, Rituximab, Vincristine, Methotrexate, Ono-4059, Procarbazine, Ono-4685, Bevacizumab, Fluorouracil, Oxaliplatin, Cetuximab, Levofolinate, Ono-7913, Ono-4538, Nivolumab, Magrolimab, Bevacizumab, Fluorouracil, Oxaliplatin, Capecitabine, Ono-4538, Ono-4578, Calcium Levofolinate Hydrateb, Nivolumab, 5-Fu, Avastin, Abemaciclib, Palbociclib, Letrozole, Ono-4578, Fluorouracil, Oxaliplatin, Irinotecan, Levofolinate, Ono-7913, Ono-4538, Gemcitabine, Nab-Paclitaxel, Fluorouracil, Oxaliplatin, Irinotecan, Levofolinate, Ono-4538, Ono-4578, Gemcitabine, Nab-Paclitaxel, Ono-4538, Ono-7475, Ono-2910, Ono-7475, Osimertinib Mesylate, Ono-4538, Ono-7914, Oxaliplatin, Capecitabine, Nivolumab, S-1, Ono-4578, Opdivo, Ono-2808, Nivolumab, Oxaliplatin, Capecitabine, Ipilimumab, S-1, Ono-4538, Yervoy, Opdivo. These drug candidates are in various stages of clinical development as the company works toward FDA approval.