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

Clinical Trials

Abexinostat and Ibrutinib in Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma

Phase 1

Completed

Conditions: Mantle Cell Lymphoma
Diffuse Large B-cell Lymphoma

Interventions: Drug: Abexinostat
Drug: Ibrutinib

First Posted Date: 2019-05-06

Last Posted Date: 2025-04-25

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 15

Registration Number: NCT03939182

Locations: 🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States

and more 4 locations

Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients

Phase 1

Terminated

Conditions: Diffuse Large B-cell Lymphoma

Interventions: Biological: Tisagenlecleucel
Drug: Ibrutinib

First Posted Date: 2019-03-15

Last Posted Date: 2023-01-31

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 10

Registration Number: NCT03876028

Locations: 🇺🇸
University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

Phase 1

Completed

Conditions: Mantle Cell Lymphoma (MCL)

Interventions: Drug: Copanlisib
Drug: Ibrutinib

First Posted Date: 2019-03-15

Last Posted Date: 2022-12-14

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 8

Registration Number: NCT03877055

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States

and more 3 locations

A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia

Phase 2

Completed

Conditions: Leukemia
T-cell Prolymphocytic Leukemia (T-PLL)
Cancer

Interventions: Drug: Venetoclax
Drug: Ibrutinib

First Posted Date: 2019-03-13

Last Posted Date: 2022-12-19

Lead Sponsor: AbbVie

Target Recruit Count: 14

Registration Number: NCT03873493

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center /ID# 207746, Houston, Texas, United States
🇬🇧
Oxford University Hospitals NHS Foundation Trust /ID# 211264, Oxford, Oxfordshire, United Kingdom
🇳🇱
Maxima Medisch Centrum /ID# 207989, Eindhoven, Netherlands

and more 12 locations

Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia

Phase 2

Conditions: AIHA - Warm Autoimmune Hemolytic Anemia

Interventions: Drug: Ibrutinib

First Posted Date: 2019-02-01

Last Posted Date: 2020-01-10

Lead Sponsor: Eugene Nikitin

Target Recruit Count: 50

Registration Number: NCT03827603

Locations: 🇷🇺
Eugene Nikitin, Moscow, Russian Federation

Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

Phase 1

Active, not recruiting

Conditions: Chronic Graft Versus Host Disease

Interventions: Drug: Ibrutinib

First Posted Date: 2018-12-31

Last Posted Date: 2023-11-14

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 59

Registration Number: NCT03790332

Locations: 🇺🇸
Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
🇫🇷
Hôpital Robert-Debré Ap-Hp, Paris, France
🇮🇱
The Edmond and Lily Safra Children's Hospital, Ramat Gan, Israel

and more 45 locations

Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma

Phase 2

Completed

Conditions: Recurrent Central Nervous System Lymphoma
Refractory Central Nervous System Lymphoma
Central Nervous System B-Cell Non-Hodgkin Lymphoma

Interventions: Drug: Ibrutinib
Biological: Nivolumab

First Posted Date: 2018-12-10

Last Posted Date: 2025-02-28

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 18

Registration Number: NCT03770416

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Ibrutinib, Obinutuzumab and Venetoclax for Patients With Chronic Lymphocytic Leukemia

Phase 2

Completed

Conditions: B-Cell Chronic Lymphocytic Leukemia
B-Cell Chronic Lymphocytic Leukemia in Relapse (Diagnosis)

Interventions: Drug: Ibrutinib
Drug: Obinutuzumab
Drug: Venetoclax

First Posted Date: 2018-11-28

Last Posted Date: 2021-02-02

Lead Sponsor: Grupo Cooperativo de Hemopatías Malignas

Target Recruit Count: 3

Registration Number: NCT03755947

Locations: 🇲🇽
Grupo Cooperativo de Hemopatías Malignas, Huixquilucan, Estado De México, Mexico

Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia

Phase 3

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Ibrutinib
Biological: Obinutuzumab
Other: Observation Activity
Drug: Venetoclax

First Posted Date: 2018-11-13

Last Posted Date: 2025-05-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 465

Registration Number: NCT03737981

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
🇺🇸
Anchorage Radiation Therapy Center, Anchorage, Alaska, United States

and more 856 locations

Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia with P53 Dysfunction

Phase 2

Active, not recruiting

Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia

Interventions: Drug: Ibrutinib
Drug: Daratumumab

First Posted Date: 2018-11-07

Last Posted Date: 2024-10-29

Lead Sponsor: French Innovative Leukemia Organisation

Target Recruit Count: 29

Registration Number: NCT03734198

Locations: 🇫🇷
Hôpital Robert Debré - Hématologie Clinique, Reims, France
🇫🇷
Chu Amiens Sud, Amiens, France
🇫🇷
CHU Jean Minjoz - Hématologie, Besançon, France

and more 21 locations

Drug Development Updates

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