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-biological Characteristics and Outcome of Chronic Lymphocytic Leukemia Under Ibrutinib-named Patient Program
- First Posted Date
- 2015-10-21
- Last Posted Date
- 2021-09-13
- Target Recruit Count
- 264
- Registration Number
- NCT02582320
- Locations
- 🇮🇹
U.O.C. Ematologia - IRCCS Centro oncologico della Basilicata, Rionero in Vulture, Italy
🇮🇹Policlinico Umberto I, Hematology Department - Sapienza, Rome, Italy
🇮🇹Sezione di Ematologia Cancer Center Humanitas, Rozzano, Italy
Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma
- Conditions
- Interventions
- First Posted Date
- 2015-10-21
- Last Posted Date
- 2024-07-25
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 18
- Registration Number
- NCT02581930
- Locations
- 🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States
🇺🇸USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸Los Angeles General Medical Center, Los Angeles, California, United States
Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors
- First Posted Date
- 2015-10-14
- Last Posted Date
- 2020-09-11
- Target Recruit Count
- 20
- Registration Number
- NCT02575300
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-09-29
- Last Posted Date
- 2021-05-06
- Lead Sponsor
- Margaret Tempero
- Target Recruit Count
- 18
- Registration Number
- NCT02562898
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸Oregon Health and Science University, Portland, Oregon, United States
A Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- First Posted Date
- 2015-09-22
- Last Posted Date
- 2019-08-14
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 8
- Registration Number
- NCT02556892
Ibrutinib and Azacitidine for Treatment of Higher Risk Myelodysplastic Syndrome
- First Posted Date
- 2015-09-18
- Last Posted Date
- 2022-10-06
- Lead Sponsor
- Brian Jonas
- Target Recruit Count
- 21
- Registration Number
- NCT02553941
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2015-09-14
- Last Posted Date
- 2019-11-21
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 11
- Registration Number
- NCT02548962
- Locations
- 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸Medical University of South Carolina, Charleston, South Carolina, United States
Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2015-09-07
- Last Posted Date
- 2022-04-14
- Lead Sponsor
- The Lymphoma Academic Research Organisation
- Target Recruit Count
- 52
- Registration Number
- NCT02542514
- Locations
- 🇫🇷
CHU d'ESTAING, Clermont Ferrand, France
🇫🇷CHRU de LILLE - Claude Huriez, Lille, France
🇫🇷Centre Léon Bérard, Lyon, France
A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2015-09-01
- Last Posted Date
- 2024-07-30
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 54
- Registration Number
- NCT02537613
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
Ibrutinib in Combination With Rituximab and Lenalidomide in Treating Patients With Previously Untreated, Stage II-IV Follicular Lymphoma or Marginal Zone Lymphoma
- Conditions
- Ann Arbor Stage II Follicular LymphomaAnn Arbor Stage II Marginal Zone LymphomaAnn Arbor Stage III Follicular LymphomaAnn Arbor Stage III Marginal Zone LymphomaAnn Arbor Stage IV Follicular LymphomaAnn Arbor Stage IV Marginal Zone LymphomaCD20 PositiveGrade 1 Follicular LymphomaGrade 2 Follicular LymphomaGrade 3a Follicular Lymphoma
- Interventions
- First Posted Date
- 2015-08-25
- Last Posted Date
- 2023-09-25
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 46
- Registration Number
- NCT02532257
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.