MIFEPREX (mifepristone)
MIFEPREX is indicated for the treatment of Hyperglycemia; Hypercortisolism; Cushing's Syndrome; Type 2 Diabetes; Glucose Intolerance.
How MIFEPREX Works
Mifepristone acts as a selective antagonist of the progesterone receptor at low doses. At the higher doses used for Cushing's syndrome, it blocks the glucocorticoid receptor (GR-II), inhibiting the effects of excess cortisol on glucose metabolism. It has high affinity for the GR-II receptor but low affinity for the GR-I (mineralocorticoid) receptor, and little to no affinity for estrogen, muscarinic, histaminic, or monoamine receptors.
Details
- Status
- Prescription
- First Approved
- 2000-09-28
- Routes
- ORAL
- Dosage Forms
- TABLET
MIFEPREX Approval History
What MIFEPREX Treats
5 indicationsMIFEPREX is approved for 5 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperglycemia
- Hypercortisolism
- Cushing's Syndrome
- Type 2 Diabetes
- Glucose Intolerance
MIFEPREX Boxed Warning
TERMINATION OF PREGNANCY Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with KORLYM and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a ...
WARNING: TERMINATION OF PREGNANCY Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with KORLYM and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential. WARNING: TERMINATION OF PREGNANCY See full prescribing information for complete boxed warning. Mifepristone has potent antiprogestational effects and will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with KORLYM, or if treatment is interrupted for more than 14 days in females of reproductive potential.
MIFEPREX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in MIFEPREX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MIFEPREX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to MIFEPREX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
57 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05322252 MIST results posted | 202202144 | Ph 4 | completed | Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial |
| NCT05304273 | G&O/CNMC-118 dt29.12.2021 | Ph 3 | completed | Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages |
| NCT06099769 | 22-334 | Ph 2 | recruiting | A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer |
| NCT03225547 | IRB17-0721 | Ph 2 | terminated | Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer |
| NCT05177510 MOLI | CW003 2021-004860-93 | Ph 2 | recruiting | Mifepristone Outpatient Labour Induction |
| NCT06502158 | 2024-15999 | Ph 1 | recruiting | Mifepristone vs Misoprostol |
| NCT02788981 results posted | IRB16-0403 | Ph 2 | active not recruiting | Abraxane® With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer |
| NCT02989662 results posted | IRB00138426 U01AA020890, AA020890 | Ph 1, Ph 2 | completed | INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers |
| NCT04254627 E/M | GWICTIC-EMphase1 CDMRP-PC16GW170044 | Ph 1 | active not recruiting | TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset |
| NCT05341817 | CIRB 202110-00035 | Ph 4 | recruiting | The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy |
| NCT05217758 RESET-m | RESET001 | Ph 2 | completed | RESET-medication Glucocorticoid Receptor (GR) Blockade As Disease Modifying Treatment for Depression with Childhood Trauma |
| NCT03913104 results posted | 18-26819 | Ph 4 | completed | Mail Order Mifepristone Study |
| NCT05097326 MiLI results posted | 62448 | Ph 3 | completed | Mifepristone for Labor Induction |
| NCT06492889 | 8007 | Ph 2, Ph 3 | not yet recruiting | Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens |
| NCT01294319 results posted | 110078 11-CH-0078 | Ph 2 | completed | Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men |
| NCT04588688 results posted | HUM00160641 | Ph 2 | terminated | Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency |
| NCT02012296 results posted | IRB13-0979 NCI-2013-02151, CDMRP-PC121149 | Ph 1, Ph 2 | completed | Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer |
| NCT02412618 MMSAP results posted | 2012-245 | Ph 4 | completed | Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation |
| NCT00698022 results posted | C-1073-205 | Ph 1 | completed | A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers |
| NCT01898312 | 2012-003703-35 | Ph 2 | completed | BRCA1/2 and Effect of Mifepristone on the Breast |
| NCT02704481 | 1035 | Ph 4 | terminated | Non-surgical Alternatives to Treatment of Failed Medical Abortion |
| NCT04063904 | 1044 | Ph 4 | terminated | Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia |
| NCT03320057 results posted | A128753 | Ph 4 | completed | Medication Abortion Via Pharmacy Dispensing |
| NCT01419535 results posted | 110208 11-CH-0208, ZIADK075121 | Ph 1, Ph 2 | completed | Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults |
| NCT02620904 MIFD results posted | 2015-5689 | Ph 4 | terminated | Mifepristone Induction for Fetal Demise |
| NCT00721201 | STH14791 | Ph 1, Ph 2 | completed | Glucocorticoid Receptor Antagonism in Subclinical Cushings |
| NCT02642939 | MIF-01-2014 | Ph 2 | terminated | Study of Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer |
| NCT01333098 Mifepristone results posted | 201011836 | Ph 1, Ph 2 | completed | Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders |
| NCT03212352 Triple M | 62449 | Ph 4 | terminated | Comparing Two Medical Treatments for Early Pregnancy Failure. |
| NCT03520439 ETESRTA | MF2018 | Ph 2, Ph 3 | completed | Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis |
| NCT03508635 | CORT125134-120 2014-001951-21 | Ph 1 | completed | CORT125134 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) |
| NCT02012491 PreFaiR results posted | 818434 1R01HD071920-01A1 | Ph 3 | completed | Comparative Effectiveness of Pregnancy Failure Management Regimens |
| NCT01212588 results posted | 1011002977 | Ph 2 | terminated | Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD) |
| NCT02633761 | 1019 | Ph 3 | terminated | Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death |
| NCT02342002 | 1015 | Ph 4 | terminated | Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial |
| NCT01134198 results posted | 6013 RU486 for Cocaine Dependence | Ph 2, Ph 3 | completed | Investigation of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients |
| NCT01493310 | 11-0546 NCI-2011-03525 | Ph 1 | completed | Nab-paclitaxel (Abraxane) With or Without Mifepristone in Patients With Advanced Breast Cancer |
| NCT02046421 | IRB13-1000 NCI-2014-00107, IRB13-1000 | Ph 1 | completed | Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer |
| NCT02981030 | 1037 | Ph 4 | completed | Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine |
| NCT02985229 | 1028 | Ph 3 | completed | Acceptability and Feasibility of Medical Abortion in Singapore |
| NCT01990560 results posted | GCO 13-1061 | Ph 4 | completed | Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism |
| NCT03258372 | C1073-37 | Ph 1 | completed | Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites |
| NCT02354170 STOMP-CSC | STOMP-CSC | Ph 2 | completed | Short-Term Oral Mifepristone for Central Serous Chorioretinopathy |
| NCT01490697 results posted | 2009P000647 | Ph 4 | completed | Developing Memory Reconsolidation Blockers as Novel Posttraumatic Stress Disorder (PTSD) Treatments |
| NCT01436279 SaMi2 results posted | H-31032 AU 6003109 | Ph 3 | completed | Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks |
| NCT00637494 results posted | C-1073-14 | Ph 3 | terminated | A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features |
| NCT01631682 results posted | W81XWH-11-2-0092 | Ph 4 | completed | Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders |
| NCT00691067 | GW060048 | Ph 4 | completed | A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness |
| NCT02720991 | 1014 | Ph 4 | completed | A Pilot of an Outpatient Regimen of Medical Abortion With Mifepristone and Sublingual Misoprostol in the 11 and 12 Weeks |
| NCT01920022 | QW2013 | Ph 4 | completed | Quickstart of Nexplanon® at Medical Abortion |
Showing 50 of 57 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MIFEPREX FDA Label Details
Indications & Usage
FDA Label (PDF)MIFEPREX is indicated for the treatment of Hyperglycemia; Hypercortisolism; Cushing's Syndrome; Type 2 Diabetes; Glucose Intolerance.
WARNING: TERMINATION OF PREGNANCY Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the init...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.