Also known as: Ono Pharmaceutical
ONO Pharmaceutical Co., Ltd. is a long-established Japanese pharmaceutical company founded in 1717 and incorporated in 1947. It develops and sells prescription pharmaceuticals and diagnostic reagents, and is listed on the Tokyo Stock Exchange.
Monash University and Ono Pharmaceutical have signed two licence agreements for the development of anti-GPCR antibodies targeting autoimmune and inflammatory diseases. The agreements result from Ono exercising options on research collaborations announced in 2023. The partnership combines Monash's research excellence with Ono's drug development capabilities to address unmet medical needs.
The FDA accepted a new drug application for tirabrutinib to treat relapsed or refractory primary central nervous system lymphoma, with a decision expected December 18, 2026. The application is supported by phase 2 trial data showing a 67% overall response rate.
The FDA has accepted for filing the New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07594158 |
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds |
RECRUITING | PHASE3 |
| NCT07429266 |
A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV) |
RECRUITING | PHASE3 |
| NCT07198087 |
A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT07169708 |
A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL) |
RECRUITING | |
| NCT07104032 |
IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) |
RECRUITING | PHASE3 |
| NCT06948448 |
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 |
RECRUITING | PHASE2 |
| NCT06803823 |
A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia |
RECRUITING | PHASE2 |
| NCT06714370 |
Real-World Evidence of Effectiveness and Safety of Tirabrutinib in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma in Taiwan: A Nationwide Study |
COMPLETED |
