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
- -
A Study of ABT-199 Plus Ibrutinib and Rituximab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2017-05-02
- Last Posted Date
- 2022-10-10
- Lead Sponsor
- Hackensack Meridian Health
- Target Recruit Count
- 10
- Registration Number
- NCT03136497
- Locations
- 🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Ibrutinib With or Without Bortezomib and Dexamethasone in Treating Patients With Relapsed or Refractory Immunoglobulin Light Chain Amyloidosis
- Conditions
- Interventions
- First Posted Date
- 2017-04-26
- Last Posted Date
- 2018-03-02
- Lead Sponsor
- Mayo Clinic
- Registration Number
- NCT03130348
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- Conditions
- Interventions
- First Posted Date
- 2017-04-25
- Last Posted Date
- 2024-10-29
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 90
- Registration Number
- NCT03128879
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation
- Conditions
- Interventions
- First Posted Date
- 2017-04-20
- Last Posted Date
- 2023-02-17
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 9
- Registration Number
- NCT03121534
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)
- Conditions
- Interventions
- First Posted Date
- 2017-04-13
- Last Posted Date
- 2023-07-18
- Lead Sponsor
- Incyte Corporation
- Target Recruit Count
- 330
- Registration Number
- NCT03112603
- Locations
- 🇵🇷
Incyte Investigative Site, Ponce, Puerto Rico
🇬🇧Novartis Investigative Site, Manchester, United Kingdom
🇷🇴Novartis Investigational Site, Bucharest, Romania
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)
- Conditions
- Interventions
- First Posted Date
- 2017-04-13
- Last Posted Date
- 2024-07-01
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 352
- Registration Number
- NCT03112174
- Locations
- 🇺🇸
UCLA Department of Medicine-Hematology/Oncology, Los Angeles, California, United States
🇺🇸The University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
🇧🇪Institut Jules Bordet, Bruxelles, Belgium
Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma
- First Posted Date
- 2017-03-28
- Last Posted Date
- 2023-10-11
- Lead Sponsor
- National Cancer Centre, Singapore
- Target Recruit Count
- 5
- Registration Number
- NCT03093831
- Locations
- 🇸🇬
National Cancer Centre Singapore, Singapore, Singapore
🇸🇬Singapore General Hospital, Singapore, Singapore
A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)
- First Posted Date
- 2017-02-15
- Last Posted Date
- 2024-10-26
- Lead Sponsor
- BeiGene
- Target Recruit Count
- 201
- Registration Number
- NCT03053440
- Locations
- 🇺🇸
Mayo Clinic Phoenix, Phoenix, Arizona, United States
🇺🇸City of Hope National Medical Center, Duarte, California, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL
- First Posted Date
- 2017-02-07
- Last Posted Date
- 2021-09-29
- Lead Sponsor
- Steven E. Coutre
- Target Recruit Count
- 22
- Registration Number
- NCT03045328
- Locations
- 🇺🇸
Stanford University, School of Medicine, Stanford, California, United States
🇺🇸City of Hope, Duarte, California, United States
Ibrutinib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Ineligible for Transplant
- First Posted Date
- 2017-01-10
- Last Posted Date
- 2023-03-07
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 18
- Registration Number
- NCT03015792
- Locations
- 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.