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.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| endocrine system diseases | D004700 |
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 |
|---|---|---|---|---|
| LYSODREN | Esteve Pharmaceuticals | N-016885 RX | 1982-01-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lysodren | New Drug Application | 2025-10-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| adrenocortical carcinoma | — | D018268 | — |
| cushing syndrome | EFO_0003099 | D003480 | E24 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
23 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 |
|---|---|---|---|---|---|---|---|---|---|
| Adrenocortical carcinoma | D018268 | — | — | 1 | 10 | 4 | — | 4 | 19 |
| Carcinoma | D002277 | — | C80.0 | — | 9 | 4 | — | 2 | 15 |
| Adrenal cortex neoplasms | D000306 | — | C74.0 | 1 | 1 | 1 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adrenal gland neoplasms | D000310 | EFO_0003850 | C74 | — | 1 | — | — | 2 | 3 |
| Urologic neoplasms | D014571 | — | C64-C68 | — | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 1 | — | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | 1 | — | — | — | 1 |
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | 1 | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adrenal insufficiency | D000309 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mitotane |
| INN | mitotane |
| 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-ID | 53-19-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1670 |
| ChEBI ID | — |
| PubChem CID | 4211 |
| DrugBank | DB00648 |
| UNII ID | 78E4J5IB5J (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CYP11A1
CYP11A1
Organism
Homo sapiens
Gene name
CYP11A1
Gene synonyms
CYP11A
NCBI Gene ID
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
Mouse ortholog
Cyp11a1 (13070)
cholesterol side-chain cleavage enzyme, mitochondrial (Q9QZ82)
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 2,455 documents
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Safety
Black-box Warning
Black-box warning for: Lysodren
Adverse Events
Top Adverse Reactions
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1,431 adverse events reported
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