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
- -
Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2018-03-27
- Last Posted Date
- 2024-05-06
- Lead Sponsor
- Alliance Foundation Trials, LLC.
- Target Recruit Count
- 39
- Registration Number
- NCT03478514
- Locations
- 🇺🇸
St. Joseph Mercy Hospital Cancer Care Center, Ypsilanti, Michigan, United States
🇺🇸Weill Cornell Medical College, New York, New York, United States
🇺🇸Medical University of South Carolina - Hollings Cancer Center, Charleston, South Carolina, United States
Clinical Outcomes of Chronic Lymphocytic Leukemia (CCL) and Mantle Cell Lymphoma (MCL) Participants Treated With Ibrutinib: A Medical Chart Review From India
- Conditions
- Interventions
- First Posted Date
- 2018-03-26
- Last Posted Date
- 2020-08-07
- Lead Sponsor
- Johnson & Johnson Private Limited
- Target Recruit Count
- 40
- Registration Number
- NCT03476655
- Locations
- 🇮🇳
Apollo Hospitals International Limited, Ahmedabad, India
🇮🇳Healthcare Global (HCG) Hospital, Bangalore, India
🇮🇳Fortis Memorial Research Institute, Gurgaon, India
A Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)
- First Posted Date
- 2018-03-22
- Last Posted Date
- 2023-02-03
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 19
- Registration Number
- NCT03474679
- Locations
- 🇯🇵
Gunmaken Saiseikai Maebashi Hospital, Maebashi, Japan
🇯🇵The Hospital of Hyogo College of Medicine, Nishinomiya, Japan
🇯🇵Tokai University Hospital, Isehara, Japan
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- Conditions
- Interventions
- First Posted Date
- 2018-03-12
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 211
- Registration Number
- NCT03462719
- Locations
- 🇨🇦
Arthur J E Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
🇺🇸Norton Cancer Institute, Louisville, Kentucky, United States
🇺🇸John Theurer Cancer Center, Hackensack, New Jersey, United States
Daratumumab and Ibrutinib in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2018-02-27
- Last Posted Date
- 2024-05-17
- Lead Sponsor
- Jennifer Woyach
- Target Recruit Count
- 15
- Registration Number
- NCT03447808
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Avelumab, Utomilumab, Rituximab, Ibrutinib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2018-02-22
- Last Posted Date
- 2024-03-29
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 16
- Registration Number
- NCT03440567
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
- Conditions
- Interventions
- First Posted Date
- 2018-02-07
- Last Posted Date
- 2022-10-06
- Lead Sponsor
- Janssen-Cilag Ltd.
- Target Recruit Count
- 508
- Registration Number
- NCT03425591
INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
- Conditions
- Interventions
- First Posted Date
- 2018-02-06
- Last Posted Date
- 2022-06-29
- Lead Sponsor
- Incyte Corporation
- Target Recruit Count
- 50
- Registration Number
- NCT03424122
- Locations
- 🇺🇸
Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
🇺🇸University of Arizona Cancer Center - Out Pt., Tucson, Arizona, United States
🇺🇸Texas Oncology, Austin, Texas, United States
Venetoclax With High-dose Ibrutinib for CLL Progressing on Single Agent Ibrutinib
- Conditions
- Interventions
- First Posted Date
- 2018-02-05
- Last Posted Date
- 2024-07-05
- Lead Sponsor
- Michael Choi
- Target Recruit Count
- 24
- Registration Number
- NCT03422393
- Locations
- 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
- Conditions
- Interventions
- First Posted Date
- 2018-01-17
- Last Posted Date
- 2023-11-14
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 39
- Registration Number
- NCT03400176
- Locations
- 🇺🇸
University of California San Diego - Moores Cancer Center, La Jolla, California, United States
🇺🇸David Geffen School of Medicine at UCLA David Geffen School of Med, Los Angeles, California, United States
🇺🇸Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University, Columbus, Ohio, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.