Ibrutinib
- Generic Name
- Ibrutinib
- Brand Names
- Imbruvica
- Drug Type
- Small Molecule
- Chemical Formula
- C25H24N6O2
- CAS Number
- 936563-96-1
- Unique Ingredient Identifier
- 1X70OSD4VX
- Background
Ibrutinib is a small molecule that acts as an irreversible potent inhibitor of Burton's tyrosine kinase. It is designated as a targeted covalent drug and presented as a promising activity in B-cell malignancies in clinical trials. Ibrutinib was developed by Pharmacyclics Inc and was first approved by the FDA in November 2013 for the treatment of mantle cell lymphoma (MCL) under accelerated approval; however, in April 2023, the drug manufacturer withdrew the accelerated approvals for ibrutinib in the US.
Ibrutinib was approved by the EMA in October 2014 and by Health Canada in November 2014. It is currently approved for the treatment of various conditions, such as chronic lymphocytic leukemia (CLL), Waldenström's Macroglobulinemia, and chronic graft versus host disease (cGVHD) in August 2017. Notably, ibrutinib became the first FDA-approved cGVHD treatment for children in August 2017.
- Indication
Ibrutinib is indicated for the treatment of the following conditions.
Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
Waldenström's macroglobulinemia
Chronic graft-versus-host disease (cGVHD)
Mantle cell lymphoma (MCL)
Marginal zone lymphoma (MZL)
- Associated Conditions
- Chronic Graft-Versus-Host Disease, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma (MZL), Refractory Mantle Cell Lymphoma, Relapsed Mantle Cell Lymphoma, Small Lymphocytic Lymphoma, Steroid-dependent chronic graft-versus-host disease, Waldenström's Macroglobulinemia (WM), Steroid refractory Chronic graft versus host disease
- Associated Therapies
- -
Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or Previously Untreated Chronic Lymphocytic Leukemia
- First Posted Date
- 2015-04-28
- Last Posted Date
- 2024-01-12
- Lead Sponsor
- Kerry Rogers
- Target Recruit Count
- 87
- Registration Number
- NCT02427451
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2015-04-28
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 131
- Registration Number
- NCT02427620
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Nivolumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or High-Risk Untreated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Richter Transformation
- First Posted Date
- 2015-04-20
- Last Posted Date
- 2024-03-20
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 37
- Registration Number
- NCT02420912
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis
- Conditions
- Interventions
- First Posted Date
- 2015-04-14
- Last Posted Date
- 2018-09-20
- Lead Sponsor
- Jason Robert Gotlib
- Target Recruit Count
- 4
- Registration Number
- NCT02415608
- Locations
- 🇺🇸
Stanford University Hospitals and Clinics, Stanford, California, United States
A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2015-04-02
- Last Posted Date
- 2021-09-20
- Lead Sponsor
- Celgene
- Target Recruit Count
- 47
- Registration Number
- NCT02406742
- Locations
- 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇦🇹University Hospital of Salzburg St Johanns Spital, Salzburg, Austria
🇺🇸The West Clinic, Memphis, Tennessee, United States
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2015-03-31
- Last Posted Date
- 2019-01-03
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 124
- Registration Number
- NCT02403271
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas
- Conditions
- Interventions
- First Posted Date
- 2015-03-27
- Last Posted Date
- 2019-06-27
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 61
- Registration Number
- NCT02401048
- Locations
- 🇺🇸
Site-0343, Hackensack, New Jersey, United States
🇺🇸Site-0397, Birmingham, Alabama, United States
🇺🇸Site-0047, Duarte, California, United States
Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy
- Conditions
- Interventions
- First Posted Date
- 2015-03-06
- Last Posted Date
- 2017-06-26
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 26
- Registration Number
- NCT02381080
Combination of Ibrutinib and Bortezomib to Treat Patients With Mantle Cell Lymphoma
- First Posted Date
- 2015-02-05
- Last Posted Date
- 2022-03-11
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Target Recruit Count
- 58
- Registration Number
- NCT02356458
- Locations
- 🇨🇭
Kantonsspital Aarau, Aarau, Switzerland
🇮🇹European Institute of Oncology, Milano, Italy
🇨🇭Kantonsspital - St. Gallen, St. Gallen, Switzerland
A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies
- Conditions
- Interventions
- First Posted Date
- 2015-02-02
- Last Posted Date
- 2023-11-14
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 15
- Registration Number
- NCT02352558
- Locations
- 🇺🇸
Virginia Oncology Associates, Norfolk, Virginia, United States
🇺🇸West Clinic, Germantown, Tennessee, United States
🇺🇸Northwest Cancer Specialists, PC, Vancouver, Washington, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.