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 and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2016-12-20
- Last Posted Date
- 2024-05-29
- Lead Sponsor
- Brian Jonas
- Target Recruit Count
- 20
- Registration Number
- NCT02997761
- Locations
- 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Efficacy and Safety of Ibrutinib in Patients With CLL and Other Indolent B-cell Lymphomas Who Are Chronic Hepatitis B Virus Carriers or Occult Hepatitis B Virus Carriers
- First Posted Date
- 2016-12-13
- Last Posted Date
- 2018-04-12
- Lead Sponsor
- The University of Hong Kong
- Target Recruit Count
- 62
- Registration Number
- NCT02991638
- Locations
- 🇭🇰
The University of Hong Kong, Hong Kong, Hong Kong
Ibrutinib for Patients With Follicular Lymphoma Without Complete Response to Initial Chemoimmunotherapy
- Conditions
- Interventions
- First Posted Date
- 2016-11-17
- Last Posted Date
- 2019-06-25
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 2
- Registration Number
- NCT02966730
- Locations
- 🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
- Conditions
- Interventions
- First Posted Date
- 2016-11-09
- Last Posted Date
- 2023-03-30
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 193
- Registration Number
- NCT02959944
- Locations
- 🇺🇸
Emory University, Winship Cancer Institute /ID# 1140-0033, Atlanta, Georgia, United States
🇺🇸Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400, Stanford, California, United States
🇺🇸Loyola University /ID# 1140-0713, Maywood, Illinois, United States
Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2016-11-06
- Last Posted Date
- 2024-05-21
- Lead Sponsor
- Georgetown University
- Target Recruit Count
- 24
- Registration Number
- NCT02956382
- Locations
- 🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States
🇺🇸John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
A Study of TAK-659 in Combination With Bendamustine (+/-Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Participants With Advanced Non-Hodgkin Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2016-11-03
- Last Posted Date
- 2022-02-18
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Target Recruit Count
- 43
- Registration Number
- NCT02954406
- Locations
- 🇺🇸
West Virginia University, Morgantown, West Virginia, United States
🇺🇸Cedars-Sinai Medical Center (CSMC) - Samuel Oschin Comprehensive Cancer Institute, West Hollywood, California, United States
🇺🇸University of Arizona Cancer Center, Tucson, Tucson, Arizona, United States
Pembrolizumab and Ibrutinib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
- Conditions
- B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classical Hodgkin LymphomaGrade 1 Follicular LymphomaGrade 2 Follicular LymphomaGrade 3a Follicular LymphomaMediastinal LymphomaRecurrent B-Cell Non-Hodgkin LymphomaRecurrent Diffuse Large B-Cell LymphomaRecurrent Lymphoplasmacytic LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone Lymphoma
- Interventions
- First Posted Date
- 2016-11-01
- Last Posted Date
- 2019-07-30
- Lead Sponsor
- Kami Maddocks
- Target Recruit Count
- 2
- Registration Number
- NCT02950220
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Interventions
- First Posted Date
- 2016-10-31
- Last Posted Date
- 2017-02-13
- Lead Sponsor
- M.D. Anderson Cancer Center
- Registration Number
- NCT02950038
Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation
- First Posted Date
- 2016-10-31
- Last Posted Date
- 2024-03-06
- Lead Sponsor
- German CLL Study Group
- Target Recruit Count
- 926
- Registration Number
- NCT02950051
- Locations
- 🇮🇱
Kaplan Medical Center, Rechovot, Israel
🇳🇱Canisius-Wilhelmina ZH, Nijmegen, Netherlands
🇳🇱Antonius Ziekenhuis Sneek, Sneek, Netherlands
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2016-10-27
- Last Posted Date
- 2024-08-26
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 445
- Registration Number
- NCT02947347
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸Swedish Cancer Institute, Seattle, Washington, United States
🇵🇹Centro Hospitalar do Porto - Hospital de Santo António, Porto, Portugal
Drug Development Updates
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