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
- -
Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-12-31
- Last Posted Date
- 2023-12-28
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 27
- Registration Number
- NCT02643667
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸Washington University School of Medicine, Saint Louis, Missouri, United States
A Drug Interaction Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults
- First Posted Date
- 2015-12-22
- Last Posted Date
- 2016-04-15
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 20
- Registration Number
- NCT02638116
Smart Start: A Phase II Study of Rituximab, Lenalidomide, and Ibrutinib
- First Posted Date
- 2015-12-21
- Last Posted Date
- 2024-03-13
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 60
- Registration Number
- NCT02636322
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Ibrutinib, Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
- Conditions
- Interventions
- First Posted Date
- 2015-12-18
- Last Posted Date
- 2018-05-14
- Lead Sponsor
- Steven E. Coutre
- Target Recruit Count
- 2
- Registration Number
- NCT02635074
- Locations
- 🇺🇸
Stanford University, School of Medicine, Palo Alto, California, United States
Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients with Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2015-12-14
- Last Posted Date
- 2024-11-19
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 81
- Registration Number
- NCT02629809
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)
- Conditions
- Interventions
- First Posted Date
- 2015-12-10
- Last Posted Date
- 2021-04-08
- Lead Sponsor
- University of Cologne
- Target Recruit Count
- 14
- Registration Number
- NCT02626884
- Locations
- 🇩🇪
1st Department of Medicine, Cologne University Hospital, Cologne, Germany
Buparlisib and Ofatumumab or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- First Posted Date
- 2015-11-25
- Last Posted Date
- 2019-09-03
- Lead Sponsor
- Emory University
- Target Recruit Count
- 1
- Registration Number
- NCT02614508
- Locations
- 🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.
- Conditions
- Interventions
- First Posted Date
- 2015-11-23
- Last Posted Date
- 2019-01-25
- Lead Sponsor
- Michael Choi
- Registration Number
- NCT02611908
Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing
- First Posted Date
- 2015-11-13
- Last Posted Date
- 2022-12-07
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 31
- Registration Number
- NCT02604511
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Massacusetts General Hospital, Boston, Massachusetts, United States
Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors
- First Posted Date
- 2015-11-06
- Last Posted Date
- 2023-11-18
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 263
- Registration Number
- NCT02599324
- Locations
- 🇺🇸
Whittingham Cancer Center at Norwalk Hospital /ID# 1128-0411, Norwalk, Connecticut, United States
🇬🇧Sarah Cannon Research Institute /ID# 1128-1079, London, England, United Kingdom
🇺🇸Franciscan Health Indianapolis /ID# 1128-1125, Indianapolis, Indiana, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.