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 |
|---|---|---|---|
| NCT07749768 |
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative Colitis |
NOT_YET_RECRUITING | PHASE1 |
| NCT07734116 |
A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma. |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07679061 |
First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE) |
RECRUITING | |
| NCT07619157 |
A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus |
RECRUITING | PHASE1 |
| NCT07618377 |
Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments |
RECRUITING | PHASE1 |
| 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 |
INTREPID: 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 |
COMPLETED | 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 |
