Overview
An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA topoisomerases, type I.
Indication
用于小细胞肺癌（SCLC）和一线治疗失败的晚期转移性卵巢癌。
Associated Conditions
- Acute Myeloid Leukemia
- Ewing's Sarcoma
- Refractory Neuroblastoma
- Metastatic Rhabdomyosarcoma
- Recurrent Stage IVB Cervical Cancer
- Refractory CNS lymphoma
- Refractory CNS malignancy
- Refractory, metastatic Ovarian cancer
- Relapsed Platinum Sensitive Small Cell Lung Cancer (SCLC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/15 | Early Phase 1 | Recruiting | |||
2025/05/01 | Phase 3 | Recruiting | |||
2025/04/16 | Phase 1 | Not yet recruiting | Nerviano Medical Sciences | ||
2025/03/03 | Phase 3 | Not yet recruiting | Hansoh BioMedical R&D Company | ||
2025/02/14 | Phase 3 | Recruiting | |||
2025/02/10 | Phase 2 | Not yet recruiting | |||
2025/01/30 | Phase 3 | Recruiting | |||
2024/12/30 | Phase 3 | Not yet recruiting | |||
2024/10/31 | Phase 1 | Not yet recruiting | Jeffrey N. Bruce | ||
2024/10/18 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Actavis Pharma, Inc. | 45963-615 | INTRAVENOUS | 4 mg in 4 mL | 8/31/2022 | |
| Novartis Pharmaceuticals Corporation | 0078-0674 | INTRAVENOUS | 4 mg in 4 mL | 7/4/2015 | |
| Novartis Pharmaceuticals Corporation | 0078-0672 | ORAL | .25 mg in 1 1 | 7/7/2017 | |
| Accord Healthcare Inc. | 16729-243 | INTRAVENOUS | 1 mg in 1 mL | 2/15/2024 | |
| Fresenius Kabi USA, LLC | 63323-762 | INTRAVENOUS | 4 mg in 4 mL | 6/23/2021 | |
| Novartis Pharmaceuticals Corporation | 0078-0673 | ORAL | 1 mg in 1 1 | 7/7/2017 | |
| Hospira, Inc. | 0409-0302 | INTRAVENOUS | 1 mg in 1 mL | 12/31/2019 | |
| Meitheal Pharmaceuticals Inc. | 71288-127 | INTRAVENOUS | 4 mg in 15 mL | 11/15/2019 | |
| Accord Healthcare, Inc. | 16729-151 | INTRAVENOUS | 4 mg in 4 mL | 11/5/2022 | |
| Fresenius Kabi USA, LLC | 63323-762 | INTRAVENOUS | 4 mg in 4 mL | 12/31/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/6/2011 | ||
Authorised | 11/12/1996 | ||
Authorised | 6/9/2010 |
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 |
|---|---|---|---|---|---|
| Topotecan Hydrochloride Capsules | 国药准字H20070203 | 化学药品 | 胶囊剂 | 5/6/2022 | |
| Topotecan Hydrochloride Capsules | 国药准字H20070204 | 化学药品 | 胶囊剂 | 5/6/2022 | |
| Topotecan Hydrochloride for Injection | 国药准字HJ20181105 | 化学药品 | 注射剂 | 1/12/2023 | |
| Topotecan Hydrochloride for Injection | 国药准字H20000438 | 化学药品 | 注射剂 | 8/31/2020 | |
| Topotecan Hydrochloride for Injection | 国药准字H20113461 | 化学药品 | 注射剂 | 11/30/2021 | |
| Topotecan Hydrochloride for Injection | 国药准字H20052432 | 化学药品 | 注射剂 | 7/27/2020 | |
| Topotecan Hydrochloride for Injection | 国药准字H20052431 | 化学药品 | 注射剂 | 7/27/2020 | |
| Topotecan Hydrochloride for Injection | 国药准字H20113482 | 化学药品 | 注射剂 | 11/30/2021 | |
| Topotecan Hydrochloride for Injection | 国药准字H20000434 | 化学药品 | 注射剂 | 4/26/2020 | |
| Topotecan Hydrochloride for Injection | 国药准字HJ20181104 | 化学药品 | 注射剂 | 1/12/2023 |
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 |
|---|---|---|---|---|---|
| TOPOTECAN ACCORD topotecan (as hydrochloride) 4 mg/4 mL concentrated injection vial | 310761 | Medicine | A | 12/4/2019 | |
| TOPOTECAN ACCORD topotecan (as hydrochloride) 1 mg/1 mL concentrated injection vial | 310762 | Medicine | A | 12/4/2019 | |
| TOPOTECAN INTAS topotecan (as hydrochloride) 4 mg/4 mL concentrated injection vial | 310763 | Medicine | A | 12/4/2019 | |
| TOPOTECAN AG topotecan (as hydrochloride) 4 mg powder for injection vial | 178010 | Medicine | A | 3/30/2012 | |
| HYCAMTIN Topotecan (as hydrochloride) 4mg powder for injection vial | 58598 | Medicine | A | 3/12/1997 | |
| TOPOTECAN INTAS topotecan (as hydrochloride) 1 mg/1 mL concentrated injection vial | 310760 | Medicine | A | 12/4/2019 |
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