Hycamtin(topotecan)
Hycamtin (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 carcinoma, ovarian neoplasms, small cell lung carcinoma, and uterine cervical neoplasms.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
| urogenital diseases | D000091642 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Hycamtin (generic drugs available since 2010-11-29)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Topotecan hydrochloride
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| hycamtin | New Drug Application | 2020-06-13 |
| topotecan hydrochloride | ANDA | 2022-08-31 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Topotecan Hydrochloride, Hycamtin, Novartis | |||
| 8158645 | 2024-12-10 | DP | |
Clinical
Clinical Trials
374 clinical trials
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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 | 33 | 41 | 18 | — | 2 | 80 |
| Neoplasms | D009369 | C80 | 44 | 14 | 2 | — | — | 53 | |
| Small cell lung carcinoma | D055752 | 15 | 27 | 13 | — | 2 | 49 | ||
| Neuroblastoma | D009447 | EFO_0000621 | 15 | 20 | 5 | — | 2 | 40 | |
| Fallopian tube neoplasms | D005185 | 14 | 15 | 7 | — | — | 32 | ||
| Lung neoplasms | D008175 | C34.90 | 13 | 18 | 3 | — | — | 31 | |
| Uterine cervical neoplasms | D002583 | 10 | 12 | 6 | — | — | 24 | ||
| Retinoblastoma | D012175 | 7 | 5 | 5 | — | 1 | 17 | ||
| Sarcoma | D012509 | 4 | 7 | 3 | — | — | 14 | ||
| Ovarian epithelial carcinoma | D000077216 | 2 | 5 | 3 | — | — | 10 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | C95 | 12 | 11 | — | — | — | 20 | |
| Central nervous system neoplasms | D016543 | 4 | 6 | — | — | 1 | 10 | ||
| Lymphoma | D008223 | C85.9 | 6 | 3 | — | — | 1 | 10 | |
| Ewing sarcoma | D012512 | EFO_0000173 | 4 | 3 | — | — | 2 | 9 | |
| Myelodysplastic syndromes | D009190 | D46 | 5 | 6 | — | — | — | 9 | |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 5 | 5 | — | — | — | 8 |
| Medulloblastoma | D008527 | 1 | 5 | — | — | — | 6 | ||
| Renal cell carcinoma | D002292 | 4 | 1 | — | — | — | 5 | ||
| Glioma | D005910 | EFO_0000520 | 4 | 1 | — | — | — | 5 | |
| Small cell carcinoma | D018288 | 2 | 4 | — | — | — | 5 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | — | — | — | — | 2 |
| Melanoma | D008545 | 2 | — | — | — | — | 2 | ||
| Astrocytoma | D001254 | EFO_0000271 | 2 | — | — | — | — | 2 | |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | — | — | — | — | 2 |
| Plasma cell neoplasms | D054219 | 2 | — | — | — | — | 2 | ||
| Clear cell sarcoma | D018227 | 2 | — | — | — | — | 2 | ||
| Esophageal neoplasms | D004938 | C15 | 2 | — | — | — | — | 2 | |
| Colorectal neoplasms | D015179 | 1 | — | — | — | — | 1 | ||
| Urinary bladder neoplasms | D001749 | C67 | 1 | — | — | — | — | 1 | |
| Cholangiocarcinoma | D018281 | C22.1 | 1 | — | — | — | — | 1 |
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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 | 57308 |
| ChEMBL ID | CHEMBL84 |
| ChEBI ID | 63632 |
| PubChem CID | 60700 |
| DrugBank | DB01030 |
| UNII ID | 7M7YKX2N15 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,018 documents
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Safety
Black-box Warning
Black-box warning for: Hycamtin, Topotecan hydrochloride
Adverse Events
Top Adverse Reactions
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141 adverse events reported
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