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 ...

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 the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

First Posted Date
2013-05-16
Last Posted Date
2020-04-13
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
838
Registration Number
NCT01855750

Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma

First Posted Date
2013-05-08
Last Posted Date
2024-07-24
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
41
Registration Number
NCT01849263
Locations
🇸🇬

National University Hospital Singapore, Singapore, Singapore

🇸🇬

National Cancer Centre Singapore, Singapore, Singapore

🇺🇸

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States

and more 10 locations

Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia

First Posted Date
2013-04-26
Last Posted Date
2024-12-10
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
44
Registration Number
NCT01841723
Locations
🇺🇸

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

🇺🇸

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

🇺🇸

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

and more 2 locations

An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

First Posted Date
2013-04-16
Last Posted Date
2018-11-07
Lead Sponsor
Janssen Biotech, Inc.
Registration Number
NCT01833039

Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma

First Posted Date
2013-04-11
Last Posted Date
2024-12-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
33
Registration Number
NCT01829568
Locations
🇺🇸

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

🇺🇸

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

and more 4 locations

A Long-term Extension Study of PCI-32765 (Ibrutinib)

First Posted Date
2013-03-05
Last Posted Date
2024-12-06
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
700
Registration Number
NCT01804686
Locations
🇺🇸

University of California Los Angeles, Los Angeles, California, United States

🇧🇪

UZ Leuven Gasthuisberg, Leuven, Belgium

🇨🇳

Peking University First Hospital, Beijing, China

and more 171 locations

A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

First Posted Date
2013-01-28
Last Posted Date
2024-12-09
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
523
Registration Number
NCT01776840

A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion

First Posted Date
2012-12-07
Last Posted Date
2017-02-27
Lead Sponsor
Pharmacyclics LLC.
Target Recruit Count
145
Registration Number
NCT01744691

Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

First Posted Date
2012-11-09
Last Posted Date
2023-09-21
Lead Sponsor
Pharmacyclics LLC.
Target Recruit Count
232
Registration Number
NCT01724346
Locations
🇪🇸

Hospital Universitario HM Sanchinarro /ID# 1116-0537, Madrid, Spain

🇪🇸

Hospital Santa Creu i Sant Pau /ID# 1116-0535, Barcelona, Spain

🇹🇷

Gazi Universitesi Tip Fakultes /ID# 1116-0608, Yenimahalle, Ankara, Turkey

and more 85 locations

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

First Posted Date
2012-11-06
Last Posted Date
2017-11-30
Lead Sponsor
Pharmacyclics LLC.
Target Recruit Count
269
Registration Number
NCT01722487
Locations
🇺🇸

Site Reference ID/Investigator #125, Atlanta, Georgia, United States

🇺🇸

Site Reference ID/Investigator #050, Pittsburgh, Pennsylvania, United States

🇺🇸

Site Reference ID/Investigator #032, Houston, Texas, United States

and more 105 locations
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