NDAORALTABLETPriority Review
Approved
Sep 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
MIFEPREX (mifepristone) by Corcept Therapeutics is anti-progestational activity of mifepristone results from competitive interaction with progesterone at progesterone-receptor sites. First approved in 2000.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MIFEPREX (mifepristone) is an oral small-molecule anti-progestational agent approved in 2000 for medical abortion when combined with misoprostol. It works by competitively blocking progesterone receptors at the uterus, sensitizing the myometrium to prostaglandin-induced contractions and terminating intrauterine pregnancy. The drug represents a non-surgical termination option with established clinical utility over two decades.
LOE Approaching
Product approaching loss of exclusivity with modest competitive pressure (30%), requiring focused reimbursement and field commercial strategy to maintain market position.
Mechanism of Action
anti-progestational activity of mifepristone results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species (mouse, rat, rabbit, and monkey), the compound inhibits the activity of endogenous or exogenous…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
Started Oct 2023
201 enrolled
Metastatic Breast Cancer
Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)
Started Mar 2023
1,113 enrolled
HypercortisolismDiabetes Mellitus, Type 2
Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
Started May 2021
3 enrolled
Central Adrenal InsufficiencyMifepristone
Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
Started Aug 2017
48 enrolled
Healthy
Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor
Started Aug 2017
33 enrolled
Drug Interaction PotentiationHealthy
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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.