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
-
Clinical Trials
Related News

A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia

First Posted Date
2017-07-21
Last Posted Date
2024-05-03
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
13
Registration Number
NCT03225716
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma

First Posted Date
2017-07-21
Last Posted Date
2024-12-19
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
145
Registration Number
NCT03223610
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas

First Posted Date
2017-07-18
Last Posted Date
2024-12-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
54
Registration Number
NCT03220022
Locations
🇺🇸

University of Illinois College of Medicine - Chicago, Chicago, Illinois, United States

🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

🇺🇸

Boston Medical Center, Boston, Massachusetts, United States

and more 18 locations

Patient-Derived Xenografts in Personalizing Treatment for Patients With Relapsed/Refractory Mantle Cell Lymphoma

First Posted Date
2017-07-17
Last Posted Date
2023-07-27
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
1
Registration Number
NCT03219047
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)

First Posted Date
2017-07-02
Last Posted Date
2024-08-06
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
24
Registration Number
NCT03207555
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

First Posted Date
2017-06-29
Last Posted Date
2023-11-28
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Target Recruit Count
15
Registration Number
NCT03204188
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas

First Posted Date
2017-06-23
Last Posted Date
2024-04-22
Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Target Recruit Count
30
Registration Number
NCT03198026
Locations
🇺🇸

Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)

First Posted Date
2017-05-15
Last Posted Date
2024-11-19
Lead Sponsor
Joshua Brody
Target Recruit Count
23
Registration Number
NCT03153202
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

Inhibition of Anaphylaxis by Ibrutinib

Phase 2
Completed
Conditions
Food Allergy
Anaphylaxis Food
Interventions
Drug: Ibrutinib
First Posted Date
2017-05-11
Last Posted Date
2018-11-16
Lead Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Target Recruit Count
6
Registration Number
NCT03149315
Locations
🇺🇸

Ann & Robert H. Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States

Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients

Phase 2
Terminated
Conditions
Richter Syndrome
Interventions
Drug: Obinutuzumab
Drug: Ibrutinib
Other: CHOP
First Posted Date
2017-05-09
Last Posted Date
2023-06-01
Lead Sponsor
Northwell Health
Target Recruit Count
3
Registration Number
NCT03145480
Locations
🇺🇸

Northwell Health/CLL Research and Treatment Program, New Hyde Park, New York, United States

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