Hycamtin(topotecan)
Hycamtin, Potactasol, Topotecan (topotecan) is a small molecule pharmaceutical. Topotecan was first approved as Hycamtin on 1996-05-28. It is used to treat non-small-cell lung carcinoma, ovarian neoplasms, small cell carcinoma, small cell lung carcinoma, and uterine cervical neoplasms in the USA. It has been approved in Europe to treat neoplasms, ovarian neoplasms, small cell lung carcinoma, and uterine cervical neoplasms.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Hycamtin, Topotecan (discontinued: Topotecan)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| hycamtin | New Drug Application | 2023-09-18 |
| topotecan | ANDA | 2024-02-15 |
| topotecan hydrochloride | ANDA | 2024-10-04 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ovarian neoplasms | EFO_0003893 | D010051 | C56 |
| non-small-cell lung carcinoma | — | D002289 | — |
| small cell carcinoma | — | D018288 | — |
| uterine cervical neoplasms | — | D002583 | — |
| small cell lung carcinoma | — | D055752 | — |
Agency Specific
FDA
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Clinical
Clinical Trials
476 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | 1 | — | — | 1 |
| Fallopian tube neoplasms | D005185 | — | — | — | — | 1 | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | 1 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Medulloblastoma | D008527 | — | — | — | 1 | — | — | — | 1 |
| Rhabdoid tumor | D018335 | — | — | — | 1 | — | — | — | 1 |
| Ewing sarcoma | D012512 | EFO_0000173 | — | — | 1 | — | — | — | 1 |
| Rhabdomyosarcoma | D012208 | — | — | — | 1 | — | — | — | 1 |
| Diffuse intrinsic pontine glioma | D000080443 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Topotecan |
| INN | topotecan |
| Description | Topotecan is a pyranoindolizinoquinoline used as an antineoplastic agent. It is a derivative of camptothecin and works by binding to the topoisomerase I-DNA complex and preventing religation of these 328 single strand breaks. It has a role as an EC 5.99.1.2 (DNA topoisomerase) inhibitor and an antineoplastic agent. |
| Classification | Small molecule |
| Drug class | antineoplastics (camptothecin derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@@]1(O)C(=O)OCc2c1cc1n(c2=O)Cc2cc3c(CN(C)C)c(O)ccc3nc2-1 |
Identifiers
| PDB | — |
| CAS-ID | 123948-87-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL84 |
| ChEBI ID | 63632 |
| PubChem CID | 60700 |
| DrugBank | DB01030 |
| UNII ID | 7M7YKX2N15 (ChemIDplus, GSRS) |
Target
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Safety
Black-box Warning
Black-box warning for: Hycamtin, Topotecan, Topotecan hydrochloride
Adverse Events
Top Adverse Reactions
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6,908 adverse events reported
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