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
A Pilot Study on Intermittent Ibrutinib in Patients With Advanced-phase Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Small Lymphocytic LymphomaChronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2021-02-25
- Last Posted Date
- 2021-02-25
- Lead Sponsor
- Jeanette Lundin
- Target Recruit Count
- 50
- Registration Number
- NCT04771507
- Locations
- 🇳🇴
St Olavs Hospital, Trondheim, Norway
🇸🇪Gävle Hospital, Gävle, Gävleborg, Sweden
🇸🇪Skåne University Hospital, Lund, Skåne, Sweden
Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Interventions
- First Posted Date
- 2021-02-17
- Last Posted Date
- 2023-10-04
- Lead Sponsor
- Paolo Ghia
- Target Recruit Count
- 55
- Registration Number
- NCT04758975
- Locations
- 🇮🇹
IRCCS Ospedale San Raffaele, Milano, MI, Italy
Clinical Study With Ibrutinib and Venetoclax for Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2021-02-15
- Last Posted Date
- 2023-10-03
- Lead Sponsor
- Paolo Ghia
- Target Recruit Count
- 31
- Registration Number
- NCT04754035
- Locations
- 🇮🇹
Ospedale San Raffaele, Milano, MI, Italy
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
- Conditions
- LymphomaNon-Hodgkin LymphomaDiffuse Large B-Cell LymphomaBurkitt Lymphoma
- Interventions
- First Posted Date
- 2021-02-05
- Last Posted Date
- 2025-03-13
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 55
- Registration Number
- NCT04739813
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Interventions
- First Posted Date
- 2020-12-28
- Last Posted Date
- 2023-01-17
- Lead Sponsor
- Inhye Ahn
- Registration Number
- NCT04685915
Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19)
- Conditions
- B-Cell NeoplasmChronic Lymphocytic LeukemiaAsymptomatic COVID-19 Infection Laboratory-ConfirmedChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaSmall Lymphocytic LymphomaMarginal Zone LymphomaWaldenstrom MacroglobulinemiaMantle Cell LymphomaSymptomatic COVID-19 Infection Laboratory-Confirmed
- Interventions
- Other: Quality-of-Life Assessment
- First Posted Date
- 2020-12-11
- Last Posted Date
- 2022-08-03
- Lead Sponsor
- Academic and Community Cancer Research United
- Registration Number
- NCT04665115
- Locations
- 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
- Conditions
- Lymphoma, Mantle-Cell
- Interventions
- First Posted Date
- 2020-12-10
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- Loxo Oncology, Inc.
- Target Recruit Count
- 500
- Registration Number
- NCT04662255
- Locations
- 🇺🇸
Alaska Oncology and Hematology, LLC, Anchorage, Alaska, United States
🇺🇸Arizona Oncology Associates, P.C. - HOPE, Phoenix, Arizona, United States
🇺🇸UCLA Medical Center, Los Angeles, California, United States
Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL)
- Conditions
- Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Interventions
- First Posted Date
- 2020-10-29
- Last Posted Date
- 2023-01-25
- Lead Sponsor
- Karyopharm Therapeutics Inc
- Target Recruit Count
- 350
- Registration Number
- NCT04607772
- Locations
- 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
🇺🇸US Oncology - Oncology Associates of Oregon, Eugene, Oregon, United States
🇺🇸University of Texas Southwestern, Dallas, Texas, United States
Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
- Conditions
- Chronic Lymphoid Leukemia
- Interventions
- First Posted Date
- 2020-10-29
- Last Posted Date
- 2024-12-31
- Lead Sponsor
- German CLL Study Group
- Target Recruit Count
- 897
- Registration Number
- NCT04608318
- Locations
- 🇩🇪
Klinikum rechts der Isar - Technische Universitaet Muenchen, München, Germany
🇳🇱Franciscus Vlietland, Schiedam, Netherlands
🇸🇪Hallands Sjukhus, Varberg, Sweden
PRECISE CURATE.AI Pilot Clinical Trial
- Conditions
- Solid Tumor
- Interventions
- First Posted Date
- 2020-08-21
- Last Posted Date
- 2023-03-29
- Lead Sponsor
- National University Hospital, Singapore
- Target Recruit Count
- 20
- Registration Number
- NCT04522284
- Locations
- 🇸🇬
Ng Teng Fong General Hospital, Singapore, Singapore
🇸🇬National University Hospital, Singapore, Singapore
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.