NDAORALTABLETPriority Review
Approved
Jul 1970
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
LYSODREN (mitotane) by Esteve is cytochrome p450 3a4 inducers [moa]. First approved in 1970.
Drug data last refreshed 8h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYSODREN (mitotane) is an oral small-molecule cytochrome P450 3A4 inducer approved in 1970 for adrenocortical carcinoma. It works by inhibiting multiple enzymes in the adrenal steroid synthesis pathway and inducing its own metabolism. The drug is used in patients with inoperable adrenocortical tumors and requires therapeutic drug monitoring due to narrow therapeutic windows.
$2.0MPart D
LOE ApproachingDeclining
Mature, specialty-focused product with small team size and limited growth; roles focused on rare disease expertise and patient support programs.
Mechanism of Action
Cytochrome P450 3A4 Inducers
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on LYSODREN offers deep expertise in orphan oncology and rare disease commercialization, with strong focus on patient outcomes and therapeutic drug monitoring. Career growth is limited by the niche market and LOE approaching status, making this role best suited for specialists seeking rare disease or regulatory mastery rather than large-scale commercial advancement.
Rare Disease SpecialistMedical Science Liaison
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.