Last reviewed · How we verify
TIRABRUTINIB
At a glance
| Generic name | TIRABRUTINIB |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2020 |
Approved indications
Common side effects
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 to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants (PHASE1)
- 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)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TIRABRUTINIB CI brief — competitive landscape report
- TIRABRUTINIB updates RSS · CI watch RSS