Overview
Ensartinib is under investigation in clinical trial NCT03420508 (Treating Patients With Melanoma and ALK Alterations With Ensartinib).
Background
Ensartinib is under investigation in clinical trial NCT03420508 (Treating Patients With Melanoma and ALK Alterations With Ensartinib).
Indication
用于此前接受过克唑替尼治疗后进展的或者对克唑替尼不耐受的间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的二线治疗。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/02 | Phase 3 | Not yet recruiting | The First Affiliated Hospital of Guangzhou Medical University | ||
2025/01/21 | Phase 4 | Not yet recruiting | |||
2025/01/17 | Phase 2 | Not yet recruiting | Peking University Cancer Hospital & Institute | ||
2025/01/16 | Phase 2 | Not yet recruiting | |||
2025/01/07 | Phase 2 | Not yet recruiting | |||
2024/08/21 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2024/07/09 | Phase 1 | Not yet recruiting | |||
2022/12/27 | Phase 1 | Completed | |||
2022/08/11 | N/A | Recruiting | |||
2022/08/08 | Phase 2 | Recruiting | Sun Yat-sen University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Xcovery Holdings, Inc. | 83076-1025 | ORAL | 25 mg in 1 1 | 12/26/2024 | |
| Xcovery Holdings, Inc. | 83076-1100 | ORAL | 100 mg in 1 1 | 12/26/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ensartinib Hydrochloride Capsules | 国药准字H20200009 | 化学药品 | 胶囊剂 | 11/17/2020 | |
| Ensartinib Hydrochloride Capsules | 国药准字H20200010 | 化学药品 | 胶囊剂 | 11/17/2020 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||