Mifeprex

(Mifepristone)

ApprovedSmall molecule

Mifepristone is used to end early pregnancies and to treat Cushing's syndrome (a condition where the body produces too much of a hormone called cortisol).[2] Mifeprex is currently approved and in use across 35 indications[4].[1]

Mifeprex is one of 588 small molecule programs targeting Abortion. It is currently in Approved.

Indications

126

Total Trials

Active Trials

587

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

AbortionUnknown status

AcceptabilityRecruiting

Cushing SyndromeActive, not recruiting

Alcohol DependenceApproved

Central Serous RetinopathyApproved

Bipolar DisorderApproved

Hepatitis C Virus InfectionApproved

Cocaine DependenceApproved

Depressive DisorderApproved

LeiomyomaApproved

AbortionApproved

Unknown status

AcceptabilityPhase 3

Recruiting

Cushing SyndromeApproved

Active, not recruiting

Alcohol DependenceApproved

Approved

Central Serous RetinopathyApproved

Approved

Bipolar DisorderApproved

Approved

Hepatitis C Virus InfectionApproved

Approved

Cocaine DependenceApproved

Approved

Depressive DisorderApproved

Approved

LeiomyomaApproved

Approved

Showing 10 of 35 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Mifeprex

DDanco

Approved

9 2

Voltaren

Novartis

Preclinical

1 3

Zolymbus

AbbVie

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Lexiscan

Astellas

Preclinical

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 7

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Post-Traumatic Stress Disorder, PTSD

NCT06689254

Q2 2027

ApprovedRecruiting

Menstrual Regulation

NCT07671989

Phase 2Recruiting

Labor, Induced

NCT05177510

Phase 1Recruiting

Cervical Preparation

NCT06502158

Q4 2027

Phase 2Recruiting

Breast Cancer

NCT06099769

Q2 2028

N/ANot yet recruiting

Miscarriage

NCT06733727

Clinical

Trials by Indication[1]

Abortion22 trials

A Pilot of an Outpatient Regimen of Medical Abortion With Mifepristone and Sublingual Misoprostol in the 11 and 12 Weeks

Completed·GGynuity Health Projects·Phase 4·NCT02720991·50 enrolled

Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation

Completed·GGynuity Health Projects·Phase 4·NCT01856985·50 enrolled

Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine

Completed·GGynuity Health Projects·Phase 4·NCT02981030·102 enrolled

Show 19 more trials

Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks

Terminated·—·N/A·NCT01636063·42 enrolled

Medication Abortion Via Pharmacy Dispensing

Completed·DDaniel Grossman·Phase 4·NCT03320057·326 enrolled

Improving Access to Abortion in the Republic of Georgia

Unknown status·CCenter for Information and Counseling on Reproductive Health - Tanadgoma·Phase 4·NCT04458558·120 enrolled

Non-surgical Alternatives to Treatment of Failed Medical Abortion

Terminated·GGynuity Health Projects·Phase 4·NCT02704481·16 enrolled

Cervical Rippening With Antiprogesterone in Midtrimester Abortions

Completed·HHadassah Medical Organization·Phase 4·NCT00410345·145 enrolled

Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Completed·—·N/A·NCT00986921·50 enrolled

Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone

Completed·GGynuity Health Projects·N/A·NCT00680394·440 enrolled

Acceptability and Feasibility of Medical Abortion in Singapore

Completed·GGynuity Health Projects·Phase 3·NCT02985229·130 enrolled

Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia

Terminated·GGynuity Health Projects·Phase 4·NCT04063904·16 enrolled

Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks

Unknown status·IIbis Reproductive Health·Phase 4·NCT02745093·648 enrolled

Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion

Completed·GGynuity Health Projects·N/A·NCT00994734·615 enrolled

Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

Completed·—·Phase 3·NCT01436279·50 enrolled

Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion

Unknown status·RRambam Health Care Campus·Phase 4·NCT03044093·200 enrolled

Quickstart of Nexplanon® at Medical Abortion

Completed·KKarolinska Institutet·Phase 4·NCT01920022·551 enrolled

A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

Unknown status·GGynuity Health Projects·Phase 4·NCT02708446·320 enrolled

Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

Terminated·GGynuity Health Projects·Phase 4·NCT02342002·416 enrolled

Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation

Completed·MMedstar Health Research Institute·Phase 4·NCT02412618·100 enrolled

Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion

Completed·GGynuity Health Projects·N/A·NCT01811056·401 enrolled

Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)

Completed·GGynuity Health Projects·Phase 4·NCT01768299·504 enrolled

Breast Cancer9 trials

Preoperative Testing of the Anti-Progesterone Mifepristone in Early Stage Breast Cancer

Terminated·UUniversity of California, San Diego·Phase 1·NCT01138553·4 enrolled

Breast Cancer BRCA1 Carriers: a Pilot Study

Withdrawn·IIndiana University··NCT05062174

Investigating the Potential Role of a Novel Quadrate Combination Therapy Mifepristone(Antiprogestrone), Tamoxifen, Retinoic Acid and Cannabidiol ( Selective Cyp 26 Inhibitor) for Treating Early Breast Cancer.

Unknown status·MMahmoud Ramadan mohamed Elkazzaz·Phase 3·NCT05016349·160 enrolled

Show 6 more trials

Mifepristone for Breast Cancer Patients With Higher Levels of Progesterone Receptor Isoform A Than Isoform B.

Completed·—·N/A·NCT02651844·20 enrolled

Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer

Terminated·UUniversity of Chicago·Phase 2·NCT03225547·24 enrolled

Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid Tumors

Completed·CCorcept Therapeutics·Phase 1·NCT02014337·37 enrolled

A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06099769·201 enrolled

Nab-paclitaxel (Abraxane) With or Without Mifepristone in Patients With Advanced Breast Cancer

Completed·UUniversity of Chicago·Phase 1·NCT01493310·9 enrolled

Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Completed·UUniversity of Chicago·Phase 1·NCT02046421·31 enrolled

Pregnancy7 trials

Comparing Two Medical Treatments for Early Pregnancy Failure.

Terminated·RRadboud University Medical Center·Phase 4·NCT03212352·342 enrolled

The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy

Recruiting·KKK Women's and Children's Hospital·Phase 4·NCT05341817·144 enrolled

Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial

Completed·WWashington University School of Medicine·Phase 4·NCT05322252·30 enrolled

Show 4 more trials

Comparative Effectiveness of Pregnancy Failure Management Regimens

Completed·UUniversity of Pennsylvania·Phase 3·NCT02012491·300 enrolled

Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso

Unknown status·GGynuity Health Projects·Phase 3·NCT03269279·100 enrolled

Termination of Pregnancy With Mifepristone and Misoprostol Versus Sulprostone

Unknown status·—··NCT00206193

Study on Combined Use of Letrozole, Mifepristone and Misoprostol in Termination of Pregnancy

Unknown status·TThe University of Hong Kong·N/A·NCT01475318·50 enrolled

Major Depression7 trials

Treatment of Psychotic Major Depression With Mifepristone

Terminated·SStanford University·Phase 3·NCT00867360·10 enrolled

A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression

Completed·CCorcept Therapeutics·Phase 3·NCT00130676·257 enrolled

An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression

Completed·CCorcept Therapeutics·Phase 3·NCT00128505·104 enrolled

Show 4 more trials

A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

Completed·CCorcept Therapeutics·Phase 3·NCT00128479·443 enrolled

A United States Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression

Completed·CCorcept Therapeutics·Phase 3·NCT00208156·87 enrolled

An International Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

Completed·CCorcept Therapeutics·Phase 3·NCT00146523·247 enrolled

A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features

Terminated·CCorcept Therapeutics·Phase 3·NCT00637494·292 enrolled

Glucocorticoid5 trials

TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset

Active, not recruiting·NNova Southeastern University·Phase 1·NCT04254627·20 enrolled

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

Completed·AAmsterdam UMC, location VUmc·Phase 2·NCT05217758·158 enrolled

INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers

Completed·JJohns Hopkins University·Phase 1/2·NCT02989662·65 enrolled

Show 2 more trials

Glucocorticoid Receptor Antagonism in Subclinical Cushings

Completed·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 1/2·NCT00721201·6 enrolled

Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT01990560·8 enrolled

57 more indications

Uterine Fibroid4 trials

Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids

Completed·MMediterranea Medica S. L.·Phase 2/3·NCT00886873·100 enrolled

A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy

Terminated·CChina Resources Zizhu Pharmaceutical Co., Ltd.·Phase 4·NCT03210324·434 enrolled

Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

Completed·BBioPro Medical Ltd·Phase 2·NCT00881140·30 enrolled

Show 1 more trial

Mifepristone for Treatment of Uterine Fibroids

Completed·MMediterranea Medica S. L.·Phase 2/3·NCT00712595·200 enrolled

ESS3 trials

The Effect of Mifepristone on the Expression of Cervical Prostaglandin EP3 Receptors

Terminated·UUniversity of Southern California·N/A·NCT01224509·18 enrolled

Assessing Medical Menstrual Regulation in the United States

Unknown status·GGynuity Health Projects·Phase 2·NCT03972358·284 enrolled

Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"

Unknown status·GGynuity Health Projects·Phase 2·NCT04676776·139 enrolled

Endogenous Cushing's Syndrome3 trials

A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome

Completed·CCorcept Therapeutics·Phase 3·NCT00569582·50 enrolled

An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome

Completed·CCorcept Therapeutics·Phase 3·NCT00936741·30 enrolled

Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome

Completed·CCorcept Therapeutics·Phase 3·NCT01371565·4 enrolled

Miscarriage2 trials

Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages

Unknown status·—·Phase 3·NCT05304273·120 enrolled

Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage

Not yet recruiting·TThe University of Hong Kong·N/A·NCT06733727·884 enrolled

Dilation and Evacuation2 trials

Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

Completed·SStanford University·N/A·NCT01615731·50 enrolled

Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services

Completed·SStanford University·N/A·NCT01862991·80 enrolled

Misoprostol2 trials

Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

Withdrawn·SStanford University·N/A·NCT02679092

Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death

Terminated·GGynuity Health Projects·Phase 3·NCT02633761·200 enrolled

Progesterone2 trials

Blocking Mifepristone Action With Progesterone

Terminated·UUniversity of California, Davis·Phase 1/2·NCT03774745·12 enrolled

Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone

Completed·RReproductive Health Research Insritute, Chile·Phase 1·NCT06616077·9 enrolled

Post-Traumatic Stress Disorder, PTSD2 trials

REVERSE: Improving Treatment-resistant Post Traumatic Stress Disorder (PTSD) with Glucocorticoid Receptor (GR) Antagonism

Recruiting·CChristiaan Vinkers·Phase 2·NCT06689254·60 enrolled

Novel Therapeutics in Posttraumatic Stress Disorder (PTSD): A Randomized Clinical Trial of Mifepristone

Completed·VVA Office of Research and Development·Phase 2·NCT01739335·81 enrolled

Interaction2 trials

Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

Completed·CCorcept Therapeutics·Phase 1·NCT03259542·33 enrolled

Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites

Completed·CCorcept Therapeutics·Phase 1·NCT03258372·48 enrolled

Acceptability2 trials

Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive

Recruiting·LLeiden University Medical Center·Phase 3·NCT06394999·1,186 enrolled

Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

Not yet recruiting·GGynuity Health Projects·Phase 2/3·NCT06492889·286 enrolled

Bipolar Depression2 trials

RU-486 in the Treatment of Bipolar Depression

Withdrawn·UUniversity of British Columbia·Phase 2·NCT00359125

Clinical Trial of Mifepristone for Bipolar Depression

Completed·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00043654·110 enrolled

Adenomyosis2 trials

Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis

Completed·Xxinmei zhang·Phase 2/3·NCT03520439·134 enrolled

Long-term Use of Mifepristone in the Treatment of Adenomyosis

Unknown status·WWomen's Hospital School Of Medicine Zhejiang University·Phase 1·NCT05151016·140 enrolled

Prostate Cancer2 trials

Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer

Completed·UUniversity of Chicago·Phase 1/2·NCT02012296·88 enrolled

Mifepristone (RU-486) in Androgen Independent Prostate Cancer

Completed·—·Phase 2·NCT00140478·48 enrolled

Labor Induction1 trial

Mifepristone for Labor Induction

Completed·SStanford University·Phase 3·NCT05097326·30 enrolled

Cancers1 trial

Compassionate Use of Mifepristone in Brain/Nervous System and Other Cancers

Terminated·NNew Mexico Cancer Research Alliance·N/A·NCT00832871·4 enrolled

Major Depressive Disorder1 trial

Mifepristone Treatment for Patients With Non-psychotic Major Depressive Disorder Receiving Bilateral ECT

Completed·SStanford University·N/A·NCT00285818·11 enrolled

Weight Gain1 trial

A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

Completed·CCorcept Therapeutics·Phase 1·NCT00698022·76 enrolled

Breast1 trial

BRCA1/2 and Effect of Mifepristone on the Breast

Completed·KKarolinska Institutet·Phase 2·NCT01898312·45 enrolled

Anxiety Disorder1 trial

Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders

Completed·MMassachusetts General Hospital·Phase 4·NCT01631682·186 enrolled

Trial1 trial

Trial of Mifepristone for Fibroids

Completed·UUniversity of Rochester·Phase 3·NCT00133705·70 enrolled

Cervical Ripening1 trial

Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction

Completed·—·N/A·NCT00383032·72 enrolled

Tobacco Use Disorder1 trial

Glucocorticoid Antagonist Treatment for Tobacco Use Disorder

Terminated·YYale University·Phase 1·NCT03248713·8 enrolled

Uterine leiomyoma1 trial

A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas

Terminated·PPoitiers University Hospital·Phase 2·NCT00219778·20 enrolled

Alcohol Use Disorder1 trial

Mifepristone Treatment of Alcohol Use Disorder

Completed·TThe Scripps Research Institute·Phase 2·NCT02179749·103 enrolled

PrEP1 trial

Cervical Preparation With Mifepristone Prior to Osmotic Dilators

Terminated·UUniversity of California, Davis·Phase 2·NCT03714880·44 enrolled

Type 2 Diabetes Mellitus1 trial

Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus

Terminated·—·Phase 2·NCT03052400·8 enrolled

Type 2 Diabetes1 trial

Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)

Completed·CCorcept Therapeutics·Phase 4·NCT05772169·1,113 enrolled

Recurrence1 trial

To Prevent Type I-II Myoma After TCRM Recurrence by Gonadotropin-releasing Hormone (GnRH )Analogues or Mifepristone

Unknown status·WWomen's Hospital School Of Medicine Zhejiang University·N/A·NCT05898321·294 enrolled

Alzheimer's Disease1 trial

Mifepristone as Adjunctive Therapy in Alzheimer's Disease

Terminated·CCorcept Therapeutics·Phase 2·NCT00105105·160 enrolled

Refractory Depression1 trial

Mifepristone in Refractory Depression

Completed·SStanford University·N/A·NCT00186056·31 enrolled

Efficacy and Safety1 trial

A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain

Completed·CCorcept Therapeutics·Phase 2·NCT00455442·57 enrolled

Non-Small Cell Lung Cancer1 trial

Study of Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Terminated·—·Phase 2·NCT02642939·3 enrolled

Endometriosis1 trial

Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis

Completed·MMediterranea Medica S. L.·Phase 2/3·NCT02271958·360 enrolled

Fallopian Tube Cancer1 trial

Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Completed·GGynecologic Oncology Group·Phase 2·NCT00459290·24 enrolled

Completed·CCorcept Therapeutics·Phase 1·NCT03508635·130 enrolled

Schizoaffective Disorder1 trial

Treatment of Schizoaffective Disorder Using Mifepristone

Terminated·SStanford University·Phase 2/3·NCT00725270·12 enrolled

Cushing's Syndrome1 trial

Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion

Terminated·HHRA Pharma·Phase 2·NCT00422201·18 enrolled

Cognitive impairment1 trial

Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders

Completed·WWashington University School of Medicine·Phase 1/2·NCT01333098·15 enrolled

Statin1 trial

A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy Volunteers

Completed·CCorcept Therapeutics·Phase 1·NCT00752843·20 enrolled

Cushing's Disease1 trial

Mifepristone in Children With Refractory Cushing's Disease

Withdrawn·CCorcept Therapeutics·Phase 3·NCT01925092

Post-Traumatic Stress Disorder1 trial

Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

Unknown status·JJames J. Peters Veterans Affairs Medical Center·Phase 2·NCT00833339·80 enrolled

Borderline personality disorder1 trial

Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD)

Terminated·IIndiana University·Phase 2·NCT01212588·22 enrolled

Meningioma1 trial

S9005 Mifepristone in Meningioma

Completed·SSWOG Cancer Research Network·Phase 3·NCT03015701·193 enrolled

Prevention1 trial

Investigation of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients

Completed·NNew York State Psychiatric Institute·Phase 2/3·NCT01134198·58 enrolled

HIV1 trial

Anti-HIV Activity and Safety of 3 Different Doses of Mifepristone in HIV Infected People

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00099645·48 enrolled

Triple-Negative Breast Cancer1 trial

Abraxane® With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer

Active, not recruiting·UUniversity of Chicago·Phase 2·NCT02788981·29 enrolled

Retinopathy1 trial

Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

Completed·—·Phase 2·NCT02354170·16 enrolled

Resistance1 trial

Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT01294319·51 enrolled

Adrenal insufficiency1 trial

Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

Terminated·TTobias Else·Phase 2·NCT04588688·3 enrolled

Endometrial Cancer1 trial

Mifepristone for Patients With Endometrial Cancer and LGESS

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00505739·13 enrolled

Memory1 trial

Developing Memory Reconsolidation Blockers as Novel Posttraumatic Stress Disorder (PTSD) Treatments

Completed·RRoger K. Pitman, MD·Phase 4·NCT01490697·34 enrolled

Menstrual Regulation1 trial

Period Pills for Menstrual Regulation: A New Reproductive Health Option

Recruiting·UUniversity of California, San Francisco·Approved·NCT07671989·100 enrolled

Labor, Induced1 trial

Mifepristone Outpatient Labour Induction

Recruiting·CChelsea and Westminster NHS Foundation Trust·Phase 2·NCT05177510·400 enrolled

Cervical Preparation1 trial

Mifepristone Versus Misoprostol for Cervical Preparation Prior to Procedural Abortion at 12 to 16 Weeks' Gestation in an Academic Medical Center: a Randomized Controlled Pilot Trial

Recruiting·MMontefiore Medical Center·Phase 1·NCT06502158·94 enrolled

Unspecified3 trials

Mifepristone Induction for Fetal Demise

Terminated·MMontefiore Medical Center·Phase 4·NCT02620904·9 enrolled

Mail Order Mifepristone Study

Completed·—·Phase 4·NCT03913104·536 enrolled

Understanding GWI: Integrative Modeling

Unknown status·SSouth Florida Veterans Affairs Foundation for Research and Education·Phase 1·NCT04255498·20 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 28, 2000

MIFEPREX

NDA NDA020687

Feb 17, 2012

KORLYM

NDA NDA202107

Sources

References

[1]
ClinicalTrials.gov — 126 trial records for Mifepristone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Mifeprex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Mifepristone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Mifepristone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA202107). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Mifeprex. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Danco company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Progesterone Receptor Antagonist; Glucocorticoid Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: DDanco

Patent Landscape[6]

Patent Cliff

Aug 27, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8921348Aug 27, 2028

10842801Nov 15, 2032

10500216Mar 5, 2033

10166243Apr 20, 2036

9943526Apr 20, 2036

13 more patents

10166242Apr 20, 2036

10660904Apr 20, 2036

10006924Aug 12, 2036

10495650Aug 12, 2036

9829495Aug 15, 2036

10151763Jan 18, 2037

10842800Jun 19, 2037

12097210Jun 19, 2037

10195214Jun 19, 2037

11969435Jun 19, 2037

10314850Aug 22, 2038

10231983Aug 22, 2038

10780097Aug 22, 2038

Mifeprex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q2 2028

Trials by Indication[1]

Abortion22 trials

Breast Cancer9 trials

Pregnancy7 trials

Major Depression7 trials

Glucocorticoid5 trials

Uterine Fibroid4 trials

ESS3 trials

Endogenous Cushing's Syndrome3 trials

Miscarriage2 trials

Dilation and Evacuation2 trials

Misoprostol2 trials

Progesterone2 trials

Post-Traumatic Stress Disorder, PTSD2 trials

Interaction2 trials

Acceptability2 trials

Bipolar Depression2 trials

Adenomyosis2 trials

Prostate Cancer2 trials

Labor Induction1 trial

Cancers1 trial

Major Depressive Disorder1 trial

Weight Gain1 trial

Breast1 trial

Anxiety Disorder1 trial

Trial1 trial

Cervical Ripening1 trial

Tobacco Use Disorder1 trial

Uterine leiomyoma1 trial

Alcohol Use Disorder1 trial

PrEP1 trial

Type 2 Diabetes Mellitus1 trial

Type 2 Diabetes1 trial

Recurrence1 trial

Alzheimer's Disease1 trial

Refractory Depression1 trial

Efficacy and Safety1 trial

Non-Small Cell Lung Cancer1 trial

Endometriosis1 trial

Fallopian Tube Cancer1 trial

Glucose intolerance1 trial

Veterans1 trial

Single Ascending Dose1 trial

Schizoaffective Disorder1 trial

Cushing's Syndrome1 trial

Cognitive impairment1 trial

Statin1 trial

Cushing's Disease1 trial

Post-Traumatic Stress Disorder1 trial

Borderline personality disorder1 trial

Meningioma1 trial

Prevention1 trial

HIV1 trial

Triple-Negative Breast Cancer1 trial

Retinopathy1 trial

Resistance1 trial

Adrenal insufficiency1 trial

Endometrial Cancer1 trial

Memory1 trial

Menstrual Regulation1 trial

Labor, Induced1 trial

Cervical Preparation1 trial

Unspecified3 trials

FDA Approval Timeline[5]

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Patent Landscape[6]

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