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 an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2015-08-10
- Last Posted Date
- 2024-05-17
- Lead Sponsor
- Jennifer Woyach
- Target Recruit Count
- 42
- Registration Number
- NCT02518555
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL
- Conditions
- Interventions
- First Posted Date
- 2015-08-03
- Last Posted Date
- 2023-03-24
- Target Recruit Count
- 29
- Registration Number
- NCT02514083
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Interventions
- First Posted Date
- 2015-06-23
- Last Posted Date
- 2024-11-01
- Lead Sponsor
- Acerta Pharma BV
- Target Recruit Count
- 533
- Registration Number
- NCT02477696
- Locations
- 🇬🇧
Research Site, Surrey, United Kingdom
ABT-199 & Ibrutinib in Mantle Cell Lymphoma (AIM)
- Conditions
- Interventions
- First Posted Date
- 2015-06-15
- Last Posted Date
- 2023-08-21
- Lead Sponsor
- Peter MacCallum Cancer Centre, Australia
- Target Recruit Count
- 37
- Registration Number
- NCT02471391
- Locations
- 🇦🇺
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
🇦🇺Royal Melbourne Hospital, Melbourne, Victoria, Australia
A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2015-06-02
- Last Posted Date
- 2020-04-24
- Lead Sponsor
- Lund University Hospital
- Target Recruit Count
- 50
- Registration Number
- NCT02460276
- Locations
- 🇸🇪
Lund University Hospital, Lund, Sweden
🇸🇪Uppsala Akademiska Hospital, Uppsala, Sweden
🇩🇰Rigshospitalet, Copenhagen, Denmark
Rituximab With or Without Ibrutinib for Patients With Advanced Follicular Lymphoma
- First Posted Date
- 2015-05-21
- Last Posted Date
- 2024-03-13
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Target Recruit Count
- 190
- Registration Number
- NCT02451111
- Locations
- 🇦🇹
Akademisches Lehrkrankenhaus Feldkirch, Feldkirch, Austria
🇩🇰Aalborg Universitetshospital, Aalborg, Denmark
🇫🇮Helsinki University Hospital, Helsinki, Finland
Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2015-05-18
- Last Posted Date
- 2024-02-22
- Lead Sponsor
- Hackensack Meridian Health
- Target Recruit Count
- 27
- Registration Number
- NCT02446236
- Locations
- 🇺🇸
The Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
- Conditions
- Interventions
- Procedure: Autologous Bone Marrow TransplantationProcedure: Autologous Hematopoietic Stem Cell TransplantationDrug: CarmustineDrug: CyclophosphamideDrug: CytarabineDrug: EtoposideDrug: IbrutinibOther: Laboratory Biomarker AnalysisDrug: MelphalanOther: Placebo AdministrationOther: Pharmacogenomic Study
- First Posted Date
- 2015-05-13
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 302
- Registration Number
- NCT02443077
- Locations
- 🇺🇸
Logan Health Medical Center, Kalispell, Montana, United States
🇺🇸Marshfield Medical Center - Minocqua, Minocqua, Wisconsin, United States
🇺🇸Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma
- First Posted Date
- 2015-05-07
- Last Posted Date
- 2024-06-12
- Lead Sponsor
- Canadian Cancer Trials Group
- Target Recruit Count
- 320
- Registration Number
- NCT02436707
- Locations
- 🇨🇦
BCCA - Vancouver, Vancouver, British Columbia, Canada
🇨🇦Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
🇨🇦Cross Cancer Institute, Edmonton, Alberta, Canada
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
- Conditions
- Interventions
- First Posted Date
- 2015-05-07
- Last Posted Date
- 2020-12-30
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 430
- Registration Number
- NCT02436668
- Locations
- 🇺🇸
Oncology Specialties, PC; Clearview Cancer Institute, Huntsville, Alabama, United States
🇺🇸Moores UCSD Cancer Center, La Jolla, California, United States
🇺🇸St. Mary's Medical Center, Daly City, California, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.