Overview
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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/06 | Not Applicable | Not yet recruiting | Inhye Ahn | ||
2025/01/23 | Phase 1 | ENROLLING_BY_INVITATION | |||
2024/10/21 | Phase 2 | Not yet recruiting | |||
2024/08/02 | Phase 1 | Recruiting | Yazeed Sawalha | ||
2024/07/01 | Phase 2 | Recruiting | Christian Schmidt, MD | ||
2024/04/10 | Phase 1 | Not yet recruiting | |||
2024/03/08 | N/A | Recruiting | Janssen Cilag S.A.S. | ||
2024/02/22 | Phase 2 | Recruiting | |||
2024/01/25 | N/A | Not yet recruiting | |||
2023/11/18 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pharmacyclics LLC | 57962-007 | ORAL | 70 mg in 1 mL | 2/29/2024 | |
| Pharmacyclics LLC | 57962-070 | ORAL | 70 mg in 1 1 | 2/29/2024 | |
| Pharmacyclics LLC | 57962-560 | ORAL | 560 mg in 1 1 | 2/29/2024 | |
| Pharmacyclics LLC | 57962-014 | ORAL | 140 mg in 1 1 | 2/29/2024 | |
| Pharmacyclics LLC | 57962-280 | ORAL | 280 mg in 1 1 | 2/29/2024 | |
| Pharmacyclics LLC | 57962-140 | ORAL | 140 mg in 1 1 | 2/29/2024 | |
| Pharmacyclics LLC | 57962-420 | ORAL | 420 mg in 1 1 | 2/29/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 10/21/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| IMBRUVICA FILM-COATED TABLETS 420MG | SIN16220P | TABLET, FILM COATED | 420mg | 6/3/2021 | |
| IMBRUVICA FILM-COATED TABLETS 140MG | SIN16218P | TABLET, FILM COATED | 140mg | 6/3/2021 | |
| IMBRUVICA FILM-COATED TABLETS 280MG | SIN16219P | TABLET, FILM COATED | 280mg | 6/3/2021 | |
| IMBRUVICA FILM-COATED TABLETS 560MG | SIN16221P | TABLET, FILM COATED | 560mg | 6/3/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ibrutinib Capsules | m/s natco pharma limited | 国药准字HJ20240120 | 化学药品 | 胶囊剂 | 10/29/2024 |
| Ibrutinib Capsules | 国药准字H20253113 | 化学药品 | 胶囊剂 | 1/8/2025 | |
| Ibrutinib Capsules | 国药准字H20249566 | 化学药品 | 胶囊剂 | 12/1/2024 | |
| Ibrutinib Capsules | 国药准字HJ20181066 | 化学药品 | 胶囊剂 | 1/30/2022 | |
| Ibrutinib Capsules | 国药准字H20223719 | 化学药品 | 胶囊剂 | 10/11/2022 | |
| Ibrutinib Tablets | 国药准字H20253032 | 化学药品 | 片剂 | 1/2/2025 | |
| Ibrutinib Tablets | 国药准字H20253031 | 化学药品 | 片剂 | 1/2/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| IMBRUVICA CAPSULES 140MG | N/A | N/A | N/A | 10/6/2017 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| IMBRUVICA ibrutinib 140 mg capsule bottle | 228499 | Medicine | A | 4/20/2015 | |
| IMBRUVICA ibrutinib 560 mg film-coated tablet blister | 319380 | Medicine | A | 8/4/2020 | |
| IMBRUVICA ibrutinib 140 mg film-coated tablet blister | 319356 | Medicine | A | 8/4/2020 | |
| IMBRUVICA ibrutinib 420 mg film-coated tablet blister | 319360 | Medicine | A | 8/4/2020 | |
| IMBRUVICA ibrutinib 280 mg film-coated tablet blister | 319357 | Medicine | A | 8/4/2020 |