Overview
Nilotinib, also known as AMN107, is a tyrosine kinase inhibitor under investigation as a possible treatment for chronic myelogenous leukemia (CML). A Phase I clinical trial in 2006 showed that this drug was relatively safe and offered significant therapeutic benefits in cases of CML which were found to be resistant to treatment with imatinib (Gleevec), another tyrosine kinase inhibitor used as a first-line treatment for CML.
Background
Nilotinib, also known as AMN107, is a tyrosine kinase inhibitor under investigation as a possible treatment for chronic myelogenous leukemia (CML). A Phase I clinical trial in 2006 showed that this drug was relatively safe and offered significant therapeutic benefits in cases of CML which were found to be resistant to treatment with imatinib (Gleevec), another tyrosine kinase inhibitor used as a first-line treatment for CML.
Indication
For the potential treatment of various leukemias, including chronic myeloid leukemia (CML).
Associated Conditions
- Accelerated Phase Chronic Myelogenous Leukemia (CML)
- Chronic Phase Chronic Myeloid Leukemia
- Newly diagnosed, chronic phase Chronic myeloid leukemia
- Refractory Gastrointestinal stromal tumor
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/10 | Phase 2 | Recruiting | |||
2022/10/03 | Phase 2 | Recruiting | |||
2022/09/26 | Phase 2 | Active, not recruiting | |||
2022/07/13 | Phase 3 | Active, not recruiting | |||
2022/03/18 | N/A | Completed | |||
2022/01/11 | Phase 2 | Active, not recruiting | |||
2021/12/03 | Phase 3 | Not yet recruiting | |||
2021/07/21 | Phase 3 | Active, not recruiting | |||
2021/05/26 | Phase 1 | Recruiting | Ruta Arays | ||
2021/05/07 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Apotex Corp. | 60505-3802 | ORAL | 200 mg in 1 1 | 4/22/2025 | |
| Apotex Corp. | 60505-3803 | ORAL | 50 mg in 1 1 | 4/22/2025 | |
| Apotex Corp. | 60505-3801 | ORAL | 150 mg in 1 1 | 4/22/2025 | |
| Novartis Pharmaceuticals Corporation | 0078-0526 | ORAL | 200 mg in 1 1 | 3/23/2018 | |
| Novartis Pharmaceuticals Corporation | 0078-0592 | ORAL | 150 mg in 1 1 | 3/23/2018 | |
| Novartis Pharmaceuticals Corporation | 0078-0951 | ORAL | 50 mg in 1 1 | 3/23/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/19/2007 | ||
Authorised | 8/22/2024 | ||
Authorised | 8/22/2024 | ||
Authorised | 11/19/2007 | ||
Authorised | 8/22/2024 | ||
Authorised | 8/22/2024 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Tasigna Capsule 150mg | SIN13959P | CAPSULE | 150mg | 5/11/2011 | |
| TASIGNA CAPSULE 50MG | SIN15837P | CAPSULE | 50mg | 10/23/2019 | |
| Tasigna Capsule 200mg | SIN13498P | CAPSULE | 200mg | 7/17/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Nilotinib Capsules | 国药准字HJ20140334 | 化学药品 | 胶囊剂 | 8/29/2023 | |
| Nilotinib Capsules | 国药准字HJ20191028 | 化学药品 | 胶囊剂 | 8/29/2023 | |
| Nilotinib Capsules | 国药准字H20223968 | 化学药品 | 胶囊剂 | 5/25/2023 | |
| Nilotinib Capsules | 国药准字HJ20171151 | 化学药品 | 胶囊剂 | 6/9/2022 | |
| Nilotinib Capsules | 国药准字HJ20140333 | 化学药品 | 胶囊剂 | 8/29/2023 | |
| Nilotinib Capsules | 国药准字H20223967 | 化学药品 | 胶囊剂 | 5/25/2023 | |
| Nilotinib Capsules | 国药准字H20233282 | 化学药品 | 胶囊剂 | 3/15/2023 | |
| Nilotinib Capsules | 国药准字H20233281 | 化学药品 | 胶囊剂 | 3/15/2023 | |
| Nilotinib Capsules | 国药准字HJ20171152 | 化学药品 | 胶囊剂 | 6/9/2022 | |
| Nilotinib Capsules | 国药准字HJ20250068 | 化学药品 | 胶囊剂 | 6/3/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TASIGNA nilotinib 200 mg capsules blister pack | 133086 | Medicine | A | 1/17/2008 | |
| TASIGNA nilotinib 150 mg capsule blister pack | 171498 | Medicine | A | 9/5/2011 |