Ibrutinib

Generic Name: Ibrutinib

Brand Names: Imbruvica

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₄N_₆O_₂

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

Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients

Phase 2

Terminated

Conditions: High Risk Smoldering Multiple Myeloma

Interventions: Drug: Ibrutinib

First Posted Date: 2016-10-24

Last Posted Date: 2020-12-16

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Target Recruit Count: 9

Registration Number: NCT02943473

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Phase 2

Active, not recruiting

Conditions: Classical Hodgkin Lymphoma

Interventions: Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Biological: Nivolumab

First Posted Date: 2016-10-20

Last Posted Date: 2024-02-23

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Target Recruit Count: 18

Registration Number: NCT02940301

Locations: 🇺🇸
Winship Cancer Center of Emory University, Atlanta, Georgia, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma

Phase 1

Completed

Conditions: Marginal Zone Lymphoma
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Recurrent Follicular Lymphoma
Mantle Cell Lymphoma
Grade 3a Follicular Lymphoma
Refractory Follicular Lymphoma

Interventions: Drug: Ibrutinib
Radiation: Radiation Therapy
Drug: TLR9 Agonist SD-101

First Posted Date: 2016-10-07

Last Posted Date: 2024-10-16

Lead Sponsor: Robert Lowsky

Target Recruit Count: 21

Registration Number: NCT02927964

Locations: 🇺🇸
Stanford University, School of Medicine, Palo Alto, California, United States

Ruxolitinib Combined With Ibrutinib in Chronic Lymphocytic Leukemia Patients

Phase 1

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Interventions: Drug: ruxolitinib
Drug: ibrutinib

First Posted Date: 2016-09-23

Last Posted Date: 2017-03-13

Lead Sponsor: Sunnybrook Health Sciences Centre

Target Recruit Count: 36

Registration Number: NCT02912754

Locations: 🇨🇦
Sunnybrook Odette Cancer Center, Toronto, Ontario, Canada

Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)

Phase 2

Completed

Conditions: Leukemia
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: ibrutinib
Drug: venetoclax
Drug: Placebo

First Posted Date: 2016-09-22

Last Posted Date: 2024-12-20

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 323

Registration Number: NCT02910583

Locations: 🇺🇸
University of Pennsylvania /ID# 1142-0069, Philadelphia, Pennsylvania, United States
🇦🇺
St Vincent's Hospital Melbourne /ID# 1142-0501, Fitzroy, Victoria, Australia
🇺🇸
Tennessee Oncology - Chattanooga /ID# 1142-0123, Chattanooga, Tennessee, United States

and more 43 locations

Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Ibrutinib
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2016-09-16

Last Posted Date: 2020-03-16

Lead Sponsor: Pharmacyclics Switzerland GmbH

Target Recruit Count: 74

Registration Number: NCT02902965

Locations: 🇨🇿
Fakultní nemocnice Brno, Brno, Czechia
🇨🇿
Fakultní nemocnice Hradec Králové, Nový Hradec Králové, Czechia
🇨🇿
Fakultní nemocnice Ostrava, Ostrava-Poruba, Czechia

and more 30 locations