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

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Small Lymphocytic Lymphoma

Interventions: Drug: Ibrutinib
Drug: Venetoclax

First Posted Date: 2023-07-27

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 320

Registration Number: NCT05963074

Locations: 🇫🇷
CHU de Reims, Reims, France
🇭🇺
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz, Nyiregyhaza, Hungary
🇪🇸
Hosp Univ Vall D Hebron, Barcelona, Spain

and more 70 locations

Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma Refractory

Interventions: Drug: Ibrutinib
Drug: Venetoclax
Drug: Navitoclax
Drug: Rituximab

First Posted Date: 2023-05-18

Last Posted Date: 2024-08-12

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 40

Registration Number: NCT05864742

Locations: 🇦🇺
Flinders Medical Centre, Bedford Park, South Australia, Australia
🇦🇺
Peter MacCallum Cancer Centre, Parkville, Victoria, Australia
🇦🇺
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Real World Data on Ibrutinib Use in PCNSL Rel/Ref

Recruiting

Conditions: PCNSL

Interventions: Drug: Ibrutinib

First Posted Date: 2023-03-23

Last Posted Date: 2023-03-23

Lead Sponsor: IRCCS San Raffaele

Target Recruit Count: 36

Registration Number: NCT05782374

Locations: 🇮🇹
Ospedale San Raffaele, Milan, Italy

Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Autoimmune Hemolytic Anemia
Small Lymphocytic Lymphoma
Monoclonal B-Cell Lymphocytosis CLL-Type

Interventions: Drug: Ibrutinib 420 mg

First Posted Date: 2023-01-23

Last Posted Date: 2023-12-01

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 45

Registration Number: NCT05694312

Locations: 🇮🇹
Ematologia Osp Molinette, Torino, Italy
🇮🇹
Ematologia Osp Careggi, Firenze, Italy
🇮🇹
Ematologia Osp Maggiore della Carità, Novara, Italy

Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation

Phase 2

Recruiting

Conditions: Richter Syndrome
Recurrent Transformed Chronic Lymphocytic Leukemia
Refractory Transformed Chronic Lymphocytic Leukemia

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Ibrutinib
Biological: Lisocabtagene Maraleucel
Biological: Nivolumab
Procedure: Pheresis
Procedure: Positron Emission Tomography

First Posted Date: 2023-01-05

Last Posted Date: 2025-04-01

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 20

Registration Number: NCT05672173

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma, Mantle-Cell

Interventions: Drug: Ibrutinib
Drug: Lenalidomide
Drug: Rituximab
Drug: Bortezomib

First Posted Date: 2022-10-03

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 36

Registration Number: NCT05564052

Locations: 🇵🇱
Szpital Specjalistyczny im Jedrzeja Sniadeckiego w Nowym Saczu, Nowy Sacz, Poland
🇵🇱
Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu, Walbrzych, Poland
🇧🇷
Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte, Brazil

and more 63 locations

A Study of Zilovertamab and Ibrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Phase 3

Withdrawn

Conditions: Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoproliferative Disorders
Lymphoma, B-Cell

Interventions: Drug: Ibrutinib
Drug: Zilovertamab
Drug: Placebo

First Posted Date: 2022-06-24

Last Posted Date: 2023-04-21

Lead Sponsor: Oncternal Therapeutics, Inc

Registration Number: NCT05431179

Efficacy and Safety of Low-dose Ibrutinib and Itraconazole in Chronic Graft Versus Host Disease

Phase 2

Conditions: Chronic Graft-versus-host-disease

Interventions: Drug: Low-dose ibrutinib

First Posted Date: 2022-04-27

Last Posted Date: 2022-04-27

Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Target Recruit Count: 13

Registration Number: NCT05348096

Locations: 🇲🇽
Hospital Universitario Dr. José Eleuterio González, Monterrey, Nuevo Leon, Mexico

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

Phase 2

Recruiting

Conditions: Non-Hodgkin Lymphoma

Interventions: Drug: Epcoritamab
Drug: Ibrutinib
Drug: Lenalidomide
Drug: CC-99282
Drug: Pirtobrutinib
Drug: Rituximab
Drug: Venetoclax
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride [HCl]
Drug: Prednisone
Drug: Polatuzumab Vedotin

First Posted Date: 2022-03-17

Last Posted Date: 2025-03-04

Lead Sponsor: Genmab

Target Recruit Count: 394

Registration Number: NCT05283720

Locations: 🇪🇸
Hospital Universitario 12 de Octubre /ID# 243262, Madrid, Spain
🇭🇺
Debreceni Egyetem-Klinikai Kozpont /ID# 242450, Debrecen, Hajdu-Bihar, Hungary
🇭🇺
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935, Kaposvár, Somogy, Hungary

and more 71 locations

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Phase 3

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Leukemia, B-cell
Leukemia, Lymphocytic
Small Lymphocytic Lymphoma

Interventions: Drug: Ibrutinib
Drug: Pirtobrutinib

First Posted Date: 2022-02-24

Last Posted Date: 2025-04-18

Lead Sponsor: Loxo Oncology, Inc.

Target Recruit Count: 650

Registration Number: NCT05254743

Locations: 🇺🇸
Eisenhower Army Medical Center, Rancho Mirage, California, United States
🇺🇸
Alta Bates Summit Medical Center, Berkeley, California, United States
🇺🇸
Baylor Scott & White Health, Round Rock, Texas, United States

and more 173 locations

Drug Development Updates

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