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
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)
Topotecan hydrochloride
Tradename
Company
Number
Date
Products
TOPOTECAN HYDROCHLORIDEHospiraN-200582 RX2011-02-02
1 products, RLD, RS
HYCAMTINSandozN-020671 RX1996-05-28
1 products, RLD, RS
HYCAMTINSandozN-020981 RX2007-10-11
2 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
hycamtinNew Drug Application2023-09-18
topotecanANDA2024-02-15
topotecan hydrochlorideANDA2024-10-04
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01C: Plant alkaloids and other natural products, antineoplastic drugs
— L01CE: Topoisomerase 1 (top1) inhibitors
— L01CE01: Topotecan
HCPCS
Code
Description
J8705
Topotecan, oral, 0.25 mg
J9351
Injection, topotecan, 0.1 mg
Clinical
Clinical Trials
455 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 neoplasmsD010051EFO_0003893C56——1——1
Fallopian tube neoplasmsD005185————1——1
Ovarian epithelial carcinomaD000077216————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuroblastomaD009447EFO_0000621—11———2
NeoplasmsD009369—C80—1———1
SarcomaD012509———1———1
MedulloblastomaD008527———1———1
Rhabdoid tumorD018335———1———1
Ewing sarcomaD012512EFO_0000173——1———1
RhabdomyosarcomaD012208———1———1
Diffuse intrinsic pontine gliomaD000080443———1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTopotecan
INNtopotecan
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.
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Classification
Small molecule
Drug classantineoplastics (camptothecin derivatives)
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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-ID123948-87-8
RxCUI—
ChEMBL IDCHEMBL84
ChEBI ID63632
PubChem CID60700
DrugBankDB01030
UNII ID7M7YKX2N15 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,555 documents
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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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6,678 adverse events reported
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