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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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Drug
Target
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Results first post date
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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 neoplasms—D002583—
small cell lung carcinoma—D055752—
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
475 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Small cell lung carcinomaD055752——2040282484
Lung neoplasmsD008175—C34.902044241383
LeukemiaD007938—C95141421128
Myeloid leukemia acuteD015470—C92.09911119
Myeloid leukemiaD007951—C92151119
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovarian neoplasmsD010051EFO_0003893C56345838—4117
Ovarian epithelial carcinomaD000077216——213924—377
NeoplasmsD009369—C8056212——70
NeuroblastomaD009447EFO_0000621—20237—250
Fallopian tube neoplasmsD005185——142114——43
Uterine cervical neoplasmsD002583——101310—231
SarcomaD012509——6114—222
RecurrenceD012008——5113—221
RetinoblastomaD012175——875—220
CarcinomaD002277—C80.0783——17
Show 36 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.976——114
Central nervous system neoplasmsD016543——49——113
GliomaD005910EFO_0000520—93———12
Nervous system neoplasmsD009423——36——110
MedulloblastomaD008527——36———9
Small cell carcinomaD018288——56———9
Myelodysplastic syndromesD009190—D4656———9
Non-hodgkin lymphomaD008228—C85.944———8
Primitive neuroectodermal tumorsD018242——14——27
SyndromeD013577——34———6
Show 88 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Follicular lymphomaD008224—C824————4
Large-cell lymphoma anaplasticD017728—C84.63————3
Biphenotypic leukemia acuteD015456—C95.02————2
Pancreatic neoplasmsD010190EFO_0003860C252————2
Female genital neoplasmsD005833——2————2
Brenner tumorD001948——2————2
B-cell chronic lymphocytic leukemiaD015451—C91.12————2
B-cell lymphoma marginal zoneD018442—C88.42————2
Mantle-cell lymphomaD020522—C83.12————2
Immunoblastic lymphadenopathyD007119EFO_1001350C86.52————2
Show 42 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)
Image (chem structure or protein)Loading
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 16,436 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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6,908 adverse events reported
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