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Thiotepa, Tepadina(thiotepa)
Tepadina (thiotepa) is a small molecule pharmaceutical. Thiotepa was first approved as Thiotepa on 1982-01-01. It is used to treat adenocarcinoma, breast neoplasms, lymphoma, ovarian neoplasms, and sarcoma amongst others in the USA. It has been approved in Europe to treat hematopoietic stem cell transplantation and neoplasms. It is known to target cytochrome P450 2B6.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
immune system diseasesD007154
therapeuticsD013812
operative surgical proceduresD013514
Trade Name
FDA
EMA
Tepadina (generic drugs available since 2001-04-02, discontinued: Thioplex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Thiotepa
Tradename
Company
Number
Date
Products
TEPADINAADIENNE SAN-208264 RX2017-01-26
2 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
tepadinaNew Drug Application2020-04-01
thiotepaANDA2023-05-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
adenocarcinomaD000230
breast neoplasmsEFO_0003869D001943C50
lymphomaD008223C85.9
ovarian neoplasmsEFO_0003893D010051C56
sarcomaD012509
urinary bladder neoplasmsD001749C67
Agency Specific
FDA
EMA
Expiration
Code
THIOTEPA, TEPADINA, ADIENNE SA
2024-01-26ODE-129
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01A: Alkylating agents
L01AC: Ethylene imines, antineoplastic alkylating drugs
L01AC01: Thiotepa
HCPCS
Code
Description
J9340
Injection, thiotepa, 15 mg
Clinical
Clinical Trials
205 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D46113121241
LeukemiaD007938C95102221131
LymphomaD008223C85.961911226
Graft vs host diseaseD006086D89.8135119
Plasma cell neoplasmsD05421912115
AnemiaD000740EFO_0004272D64.91314
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.03285134
Myeloid leukemia acuteD015470C92.03272130
Breast neoplasmsD001943EFO_0003869C506191029
Central nervous system neoplasmsD0165434132221
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340220120
NeuroblastomaD009447EFO_00006214133120
NeoplasmsD009369C80441210
Brain neoplasmsD001932EFO_0003833C7125219
RetinoblastomaD01217524129
MedulloblastomaD00852722216
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228C85.9518221
Hodgkin diseaseD006689C8129111
Hematologic neoplasmsD01933747211
Germ cell and embryonal neoplasmsD0093732619
SarcomaD0125094419
Ovarian neoplasmsD010051EFO_0003893C56569
Multiple myelomaD009101C90.01528
Biphenotypic leukemia acuteD015456C95.077
Sickle cell anemiaD000755EFO_0000697D573517
B-cell chronic lymphocytic leukemiaD015451C91.11617
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GliomaD005910EFO_000052011
Choroid plexus neoplasmsD016545EFO_000720611
Neuroepithelial neoplasmsD01830211
PinealomaD01087111
ChordomaD002817EFO_000033411
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Extranodal nk-t-cell lymphomaD054391C86.011
B-cell lymphoma marginal zoneD018442C88.411
Large-cell lymphoma anaplasticD017728C84.611
T-cell lymphoma peripheralD016411C84.911
Intraocular lymphomaD06409011
Immunoglobulin light-chain amyloidosisD00007536311
Large-cell lymphoma immunoblasticD01640011
Lymphomatoid granulomatosisD008230C83.811
Ewing sarcomaD012512EFO_000017311
HepatoblastomaD018197C22.211
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTHIOTEPA
INNthiotepa
Description
Thiotepa is a member of aziridines.
Classification
Small molecule
Drug classantineoplastics (thiotepa derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
S=P(N1CC1)(N1CC1)N1CC1
Identifiers
PDB
CAS-ID52-24-4
RxCUI10473
ChEMBL IDCHEMBL671
ChEBI ID9570
PubChem CID5453
DrugBankDB04572
UNII ID905Z5W3GKH (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CYP2B6
CYP2B6
Organism
Homo sapiens
Gene name
CYP2B6
Gene synonyms
NCBI Gene ID
Protein name
cytochrome P450 2B6
Protein synonyms
1,4-cineole 2-exo-monooxygenase, CYPIIB6, Cytochrome P450 IIB1, cytochrome P450, family 2, subfamily B, polypeptide 6, cytochrome P450, subfamily IIB (phenobarbital-inducible), polypeptide 6
Uniprot ID
Mouse ortholog
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 4,590 documents
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Safety
Black-box Warning
Black-box warning for: Tepadina
Adverse Events
Top Adverse Reactions
Mock data
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11,675 adverse events reported
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