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Ibrutinib Oral Capsule
Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK signaling in B cells and other immune cells, leading to reduced proliferation and survival of malignant B cells.
Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK signaling in B cells and other immune cells, leading to reduced proliferation and survival of malignant B cells. Used for Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), Mantle cell lymphoma (MCL).
At a glance
| Generic name | Ibrutinib Oral Capsule |
|---|---|
| Also known as | Imbruvica |
| Sponsor | Pharmacyclics LLC. |
| Drug class | Bruton's tyrosine kinase (BTK) inhibitor |
| Target | BTK (Bruton's tyrosine kinase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Ibrutinib irreversibly binds to and inhibits Bruton's tyrosine kinase, a key enzyme in B-cell receptor signaling. By blocking BTK, the drug prevents activation and proliferation of B-cell malignancies while also modulating the tumor microenvironment. This mechanism is particularly effective in B-cell lymphomas and leukemias that depend on BCR signaling for survival.
Approved indications
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Mantle cell lymphoma (MCL)
- Marginal zone lymphoma (MZL)
- Waldenström macroglobulinemia (WM)
Common side effects
- Diarrhea
- Fatigue
- Nausea
- Bruising/bleeding
- Infection
- Rash
- Atrial fibrillation
- Pneumonia
Key clinical trials
- Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma (PHASE3)
- A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia (PHASE2)
- A Long-term Extension Study of PCI-32765 (Ibrutinib) (PHASE3)
- A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (PHASE2)
- Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia (PHASE2)
- Pembrolizumab, Ibrutinib and Rituximab in PCNSL (PHASE1, PHASE2)
- Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Patients With Newly Diagnosed or Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL) (PHASE1, PHASE2)
- Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease (PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ibrutinib Oral Capsule CI brief — competitive landscape report
- Ibrutinib Oral Capsule updates RSS · CI watch RSS
- Pharmacyclics LLC. portfolio CI