NDAORALTABLET
Approved
Dec 2021
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
RECORLEV (levoketoconazole) by Bridge Therapeutics is cytochrome p450 11b1 inhibitors [moa]. First approved in 2021.
Drug data last refreshed 3h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RECORLEV (levoketoconazole) is an oral cortisol synthesis inhibitor that selectively blocks the enzyme 11B1 (part of the cytochrome P450 system), reducing cortisol production. It is approved for treating Cushing's syndrome, a rare endocrine disorder characterized by excessive cortisol levels. The mechanism targets the final step of cortisol biosynthesis, offering a targeted approach to managing this severe metabolic condition.
$10MPart D
Peak13.3 years to LOEEarly-stage peak phase with modest Part D adoption (384 claims in 2023) indicates a small, niche patient population requiring focused specialty commercial infrastructure and orphan disease expertise.
Mechanism of Action
Cytochrome P450 11B1 Inhibitors
Pharmacologic Class:
Cortisol Synthesis Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
RECORLEV offers a unique career opportunity in rare disease commercialization with deep specialization in endocrinology and Cushing's syndrome management. The niche market, small patient population, and unmet medical need require highly focused, clinically sophisticated teams that build strong relationships with a concentrated physician base and patient advocates.
Rare Disease / Orphan Product Specialist
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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.