Overview
No overview information available.
Indication
用于既往接受过克唑替尼治疗后疾病进展或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）患者的治疗。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/31 | Early Phase 1 | Recruiting | |||
2024/02/28 | Phase 2 | Not yet recruiting | Shanghai Pulmonary Hospital, Shanghai, China | ||
2023/08/15 | N/A | Recruiting | Jinming Yu | ||
2023/04/06 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Iruplinalkib Tablets | 国药准字H20247285 | 化学药品 | 片剂 | 11/13/2024 | |
| Iruplinalkib Tablets | 国药准字H20230016 | 化学药品 | 片剂 | 6/27/2023 | |
| Iruplinalkib Tablets | 国药准字H20230015 | 化学药品 | 片剂 | 6/27/2023 |
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. | |||||
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