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 10h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYSODREN (mitotane) is an oral cytochrome P450 3A4 inducer approved in 1970 for adrenocortical carcinoma and off-label uses in severe Cushing's syndrome. It works by inducing hepatic metabolism and has direct adrenolytic properties, making it a specialized endocrinology agent with narrow indication(s) and limited patient population.
$2MPart D
LOE ApproachingMature, low-revenue orphan product with minimal team expansion; roles focus on maintaining rare-disease relationships and managing legacy brand.
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/rare-disease commercialization and specialization in endocrine oncology, but limited opportunities for P&L growth or large-scale team leadership. Career value lies in niche knowledge, relationship-building with academic centers, and understanding of ultra-specialized market dynamics.
Rare Disease ManagerMedical Science Liaison (Endocrinology)
Worked on LYSODREN at Esteve? Share your interview experience or compensation data (+7 days Pro)
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.