Last reviewed · How we verify
ONO-4059
ONO-4059 is a small-molecule inhibitor of phosphoinositide 3-kinase (PI3K) that blocks PI3K signaling to suppress tumor cell proliferation and survival.
ONO-4059 is a small-molecule inhibitor of phosphoinositide 3-kinase (PI3K) that blocks PI3K signaling to suppress tumor cell proliferation and survival. Used for Relapsed or refractory lymphoma, Other hematologic malignancies.
At a glance
| Generic name | ONO-4059 |
|---|---|
| Also known as | Tirabrutinib hydrochloride, Tirabrutinib Hydrochloride |
| Sponsor | Ono Pharmaceutical Co. Ltd |
| Drug class | PI3K inhibitor |
| Target | PI3K (phosphoinositide 3-kinase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
PI3K is a key enzyme in cell survival and proliferation pathways frequently dysregulated in cancer. By inhibiting PI3K, ONO-4059 reduces downstream signaling through AKT and mTOR, leading to reduced cell survival and growth. This mechanism is particularly relevant in hematologic malignancies and solid tumors with PI3K pathway activation.
Approved indications
- Relapsed or refractory lymphoma
- Other hematologic malignancies
Common side effects
- Diarrhea
- Neutropenia
- Thrombocytopenia
- Anemia
- Hyperglycemia
Key clinical trials
- IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) (PHASE3)
- A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL (PHASE1, PHASE2)
- ONO-4059 Study in Patients With Steroid-resistant Pemphigus (PHASE3)
- Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) (PHASE2)
- A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001) (PHASE1, PHASE2)
- Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies (PHASE1)
- Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL (PHASE1)
- Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |