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Lysodren(mitotane)
Lysodren (mitotane) is a small molecule pharmaceutical. Mitotane was first approved as Lysodren on 1982-01-01. It is used to treat adrenocortical carcinoma and cushing syndrome in the USA. It has been approved in Europe to treat adrenal cortex neoplasms. It is known to target cholesterol side-chain cleavage enzyme, mitochondrial and cytochrome P450 11B1, mitochondrial.
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BMS
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
endocrine system diseasesD004700
Trade Name
FDA
EMA
Lysodren
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mitotane
Tradename
Company
Number
Date
Products
LYSODRENHRA PharmaN-016885 RX1982-01-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lysodrenNew Drug Application2020-01-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
adrenocortical carcinoma—D018268—
cushing syndromeEFO_0003099D003480E24
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XX: Other antineoplastic agents in atc
— L01XX23: Mitotane
HCPCS
No data
Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Adrenocortical carcinomaD018268—34—18
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C611————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMITOTANE
INNmitotane
Description
Mitotane is a diarylmethane.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Clc1ccc(C(c2ccccc2Cl)C(Cl)Cl)cc1
Identifiers
PDB—
CAS-ID53-19-0
RxCUI7004
ChEMBL IDCHEMBL1670
ChEBI ID—
PubChem CID4211
DrugBankDB00648
UNII ID78E4J5IB5J (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CYP11A1
CYP11A1
CYP11B1
CYP11B1
Organism
Homo sapiens
Gene name
CYP11A1
Gene synonyms
CYP11A
NCBI Gene ID
1583
Protein name
cholesterol side-chain cleavage enzyme, mitochondrial
Protein synonyms
cholesterol 20-22 desmolase, Cholesterol desmolase, cholesterol monooxygenase (side-chain cleaving), CYPXIA1, Cytochrome P450 11A1, cytochrome P450 family 11 subfamily A polypeptide 1, Cytochrome P450(scc), cytochrome P450, subfamily XIA (cholesterol side chain cleavage), steroid 20-22-lyase
Uniprot ID
Q8N1A7
Mouse ortholog
Cyp11a1 (13070)
cholesterol side-chain cleavage enzyme, mitochondrial (Q9QZ82)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,821 documents
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Safety
Black-box Warning
Black-box warning for: Lysodren
Adverse Events
Top Adverse Reactions
Mock data
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18,149 adverse events reported
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