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mifepristone

Generic: MIFEPRISTONE·Brand: KORLYM, Korlym, MIFEPREX, MIFEPRISTONE, Mifeprex

mifepristone: developed by 1 company · 5 clinical trials tracked · 1 FDA decision.

mifepristone evidence translation

What we can confirm

1 FDA record · 5 tracked trials

What it means

Source-backed records connect mifepristone to CORT; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could mifepristone → CORT affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 0 study sponsors

Related indications

Cushing's syndrome (hypercortisolism)Major Depressive DisorderMetastatic Breast Cancer

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
CORCEPT THERAPEUTICS INC (CORT)
Cushing's syndrome (hypercortisolism)
Approved
Clinical Trials (5)

Prospective Phase III Multi-center Open-label Study of the Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive

NCT06394999·Phase 3
Active, not recruiting

Primary endpoint: Overall Pearl Index

Interventionalopen615 targetStarted 2025-05Completion 2028-0114 sites · NetherlandsLeiden University Medical Center

A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER

NCT06099769·Phase 2
Recruiting

Primary endpoint: progression-free survival (PFS)

InterventionalRandomizedopen201 targetStarted 2023-10Completion 2027-1012 sites · United StatesMemorial Sloan Kettering Cancer Center

RESET-medication: Glucocorticoid Receptor (GR) Blockade As Diseasemodifying Treatment for Depression with Childhood Trauma

NCT05217758·Phase 2
Completed

Primary endpoint: Depressive symptom severity at post-treatment

InterventionalRandomizedquadruple158 enrolledStarted 2021-12Completion 2024-111 site · NetherlandsAmsterdam UMC, location VUmc

Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

NCT04588688·Phase 2
Terminated

Primary endpoint: Number of Study Participants Recruited

Interventionalopen3 targetStarted 2021-05Completion 2021-081 site · United StatesTobias Else

A Phase II Study of Treatment With Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Two or More Previous Chemotherapy Regimens

NCT02642939·Phase 2
Terminated

Primary endpoint: Overall Survival

Interventionalopen3 targetStarted 2015-12Completion 2020-101 site · United StatesCheck, Jerome H., M.D., Ph.D.
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE KORLYM (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. LIMITATIONS OF USE: KORLYM should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing's syndrome. KORLYM (mifepristone) is a cortisol receptor bl(CORT)FDA ↗
NDA202107Type 5 - New Formulation or New ManufacturerOrphan DrugStandardOralTablet

Frequently asked questions

Who is developing mifepristone?

mifepristone is being developed by CORCEPT THERAPEUTICS INC.

How many clinical trials involve mifepristone?

BioSniper tracks 5 clinical trials involving mifepristone.

What is mifepristone's latest FDA decision?

The most recent tracked FDA decision for mifepristone is Approval for 1 INDICATIONS AND USAGE KORLYM (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. LIMITATIONS OF USE: KORLYM should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing's syndrome. KORLYM (mifepristone) is a cortisol receptor bl, dated February 17, 2012.