Overview
Ponatinib is a novel Bcr-Abl tyrosine kinase inhibitor that is especially effective against the T315I mutation for the treatment of chronic myeloid leukemia. FDA approved on December 14, 2012.
Indication
1.用于治疗达沙替尼或尼洛替尼治疗无效的慢性期、进展期或急性期的慢性粒细胞白血病（CML）；或不能耐受达沙替尼或尼洛替尼者，以及临床不适合用伊马替尼进行后续治疗的患者；或T315I突变者。 2.用于治疗达沙替尼治疗无效的费城染色体阳性急性淋巴细胞白血病（Ph+ALL）；或不能耐受达沙替尼者，以及临床不适合用伊马替尼进行后续治疗的患者；或T315I突变者。
Associated Conditions
- Accelerated Phase Chronic Myelogenous Leukemia (CML)
- Acute Lymphoblastic Leukaemias (ALL)
- Chronic Phase Chronic Myeloid Leukemia
- Blast phase Chronic myeloid leukemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/25 | N/A | Completed | Dong-Wook Kim | ||
2025/02/06 | Phase 2 | Not yet recruiting | |||
2024/04/30 | N/A | Recruiting | |||
2024/01/16 | Phase 1 | Not yet recruiting | |||
2023/12/19 | N/A | Not yet recruiting | PETHEMA Foundation | ||
2023/09/29 | Phase 2 | Recruiting | Goethe University | ||
2022/04/01 | Phase 2 | Recruiting | |||
2022/03/18 | N/A | Completed | |||
2022/03/07 | Phase 2 | Active, not recruiting | |||
2021/04/14 | Phase 2 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. | 63020-534 | ORAL | 45 mg in 1 1 | 3/26/2024 | |
| Takeda Pharmaceuticals America, Inc. | 63020-536 | ORAL | 10 mg in 1 1 | 3/26/2024 | |
| Takeda Pharmaceuticals America, Inc. | 63020-533 | ORAL | 30 mg in 1 1 | 3/26/2024 | |
| Takeda Pharmaceuticals America, Inc. | 63020-535 | ORAL | 15 mg in 1 1 | 3/26/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/1/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ICLUSIG TABLET 45 MG | SIN15582P | TABLET, FILM COATED | 45 MG | 11/19/2018 | |
| ICLUSIG TABLET 15 MG | SIN15581P | TABLET, FILM COATED | 15 MG | 11/19/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ponatinib Tablets | 国药准字HJ20240090 | 化学药品 | 片剂 | 9/3/2024 |
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 |
|---|---|---|---|---|---|
| ICLUSIG ponatinib (as hydrochloride) 45 mg film-coated tablet bottle | 212584 | Medicine | A | 11/26/2014 | |
| ICLUSIG ponatinib (as hydrochloride) 15 mg film-coated tablet bottle | 212583 | Medicine | A | 11/26/2014 | |
| ICLUSIG ponatinib (as hydrochloride) 10 mg film-coated tablet bottle | 374484 | Medicine | A | 9/16/2022 | |
| ICLUSIG ponatinib (as hydrochloride) 30 mg film-coated tablet bottle | 374492 | Medicine | A | 9/16/2022 |
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