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
- -
Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL
- Conditions
- Interventions
- First Posted Date
- 2016-05-02
- Last Posted Date
- 2023-01-17
- Lead Sponsor
- University of Ulm
- Target Recruit Count
- 41
- Registration Number
- NCT02758665
- Locations
- 🇩🇪
BAG Onkologische Gemeinschaftspraxis, Dresden, Germany
🇩🇪Universitätsklinikum Essen, Essen, Germany
🇩🇪Universitätsklinikum Freiburg, Freiburg, Germany
A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2016-04-29
- Last Posted Date
- 2022-10-10
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 37
- Registration Number
- NCT02756247
- Locations
- 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸Memorial Sloan Kettering Commack, Commack, New York, United States
Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2016-04-29
- Last Posted Date
- 2024-08-02
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 234
- Registration Number
- NCT02756897
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Combination of Ibrutinib and As2O3 in the Treatment of CLL
- Conditions
- Interventions
- First Posted Date
- 2016-04-29
- Last Posted Date
- 2016-04-29
- Lead Sponsor
- Peking University People's Hospital
- Target Recruit Count
- 70
- Registration Number
- NCT02757040
Ibrutinib and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2016-04-20
- Last Posted Date
- 2024-04-29
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 39
- Registration Number
- NCT02744612
- Locations
- 🇺🇸
NYP/Weill Cornell Medical Center, New York, New York, United States
🇺🇸City of Hope Medical Center, Duarte, California, United States
🇺🇸Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Duvortuxizumab (JNJ-64052781) Plus Ibrutinib in Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2016-04-19
- Last Posted Date
- 2017-11-24
- Lead Sponsor
- Janssen Research & Development, LLC
- Registration Number
- NCT02743546
A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2016-04-13
- Last Posted Date
- 2016-05-13
- Lead Sponsor
- Acerta Pharma BV
- Registration Number
- NCT02735876
Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2016-04-13
- Last Posted Date
- 2022-01-05
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 10
- Registration Number
- NCT02736617
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2016-04-11
- Last Posted Date
- 2023-11-18
- Lead Sponsor
- Celgene
- Target Recruit Count
- 106
- Registration Number
- NCT02733042
- Locations
- 🇺🇸
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
🇺🇸Jefferson Medical Oncology Associates, Philadelphia, Pennsylvania, United States
🇫🇷Centre Hospitalier Universitaire d'Avicennes, Bobigny Cedex, France
A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2016-03-09
- Last Posted Date
- 2022-12-02
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 72
- Registration Number
- NCT02703272
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.