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Drug ReportsTopotecan
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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YTD
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2Y
5Y
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
urogenital diseasesD000091642
endocrine system diseasesD004700
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
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ovarian neoplasmsEFO_0003893D010051C56
non-small-cell lung carcinoma—D002289—
small cell carcinoma—D018288—
uterine cervical neoplasmsHP_0030159D002583—
small cell lung carcinoma—D055752—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Topotecan Hydrochloride, Hycamtin, Novartis
81586452024-12-10DP
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
447 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175HP_0100526C34.902247252390
Small cell lung carcinomaD055752——2146242487
NeuroblastomaD009447EFO_0000621—182371248
LeukemiaD007938—C95141521129
Myeloid leukemia acuteD015470—C92.04811114
Myeloid leukemiaD007951—C922511110
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovarian neoplasmsD010051EFO_0003893C56335732—4110
Ovarian epithelial carcinomaD000077216——204126—481
NeoplasmsD009369—C8054242——71
Fallopian tube neoplasmsD005185——142111——40
RecurrenceD012008——7178—231
Uterine cervical neoplasmsD002583HP_0030159—101310—231
CarcinomaD002277—C80.010157——29
SarcomaD012509——6115—223
RetinoblastomaD012175——775—219
Brain neoplasmsD001932EFO_0003833C71681——13
Show 37 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Central nervous system neoplasmsD016543——49——113
GliomaD005910EFO_0000520—104———13
LymphomaD008223—C85.975——113
Nervous system neoplasmsD009423——48——112
SyndromeD013577——56———9
Small cell carcinomaD018288——56———9
Myelodysplastic syndromesD009190—D4656———9
PreleukemiaD011289——55———8
MedulloblastomaD008527——16———7
Non-hodgkin lymphomaD008228—C85.924———6
Show 79 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AstrocytomaD001254EFO_0000271—2————2
Pancreatic neoplasmsD010190EFO_0003860C252————2
PlasmacytomaD010954—C90.32————2
Female genital neoplasmsD005833——2————2
Meningeal neoplasmsD008577EFO_0003851C702————2
Meningeal carcinomatosisD055756EFO_1001012—2————2
MeningitisD008581HP_0001287G032————2
Esophageal neoplasmsD004938—C152————2
Rectal neoplasmsD012004——2————2
Triple negative breast neoplasmsD064726——1————1
Show 24 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cervical intraepithelial neoplasia——D06————22
Uterine cervical dysplasiaD002578EFO_1000910N87————22
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.
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 15,027 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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6,466 adverse events reported
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