Drugs / Mifepristone
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Mifepristone

also known as RU-486 · Corlux · Mifegyne · Korlym · Mifeprex · VGX-410 · C-1073 · Medicane · +4 more

Small molecule

Developed for
major depressive disorder · post-traumatic stress disorder · pregnancy disorder · pregnancy disorder with abortive outcome · psychotic disorder · breast cancer · Cushing syndrome · leiomyoma
+50 more · menstrual disorder · persian gulf syndrome · uterine benign neoplasm · adenomyosis · anxiety disorder · Cushing disease due to pituitary adenoma · depressive disorder · female breast carcinoma · male breast carcinoma · malignant epithelial tumor of ovary · non-small cell lung carcinoma · primary peritoneal carcinoma · type 2 diabetes mellitus · adrenal gland hyperfunction · Alzheimer disease · bipolar disorder · borderline personality disorder · cancer · central serous chorioretinopathy · diabetes mellitus · ductal breast carcinoma in situ · ectopic Cushing syndrome · endometrial cancer · endometriosis · fallopian tube cancer · fallopian tube carcinoma · hereditary breast ovarian cancer syndrome · HIV infectious disease · hormone-resistant prostate carcinoma · invasive breast carcinoma · meningioma · occupational disorder · ovarian cancer · pregnancy loss, recurrent, 4 · preterm premature rupture of the membranes · prostate adenocarcinoma · prostate cancer · sarcoma · submucous uterine fibroid · transitional cell carcinoma · triple-negative breast carcinoma · vaginal disorder · alcohol abuse · alcohol dependence · alcohol-related disorders · benign neoplasm of corpus uteri · bipolar depression · cocaine dependence · habitual spontaneous abortion · nicotine dependence
Investigated by
Gynuity Health Projects · Corcept Therapeutics · Stanford University · Boston University · Society of Family Planning · University of Chicago
+133 more · Mediterranea Medica S. L. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Karolinska Institutet · National Cancer Institute (NCI) · University of Pittsburgh · Washington University School of Medicine · Assistance Publique Hopitaux De Marseille · Cuidado Integral de la Mujer, Gineclinic, S.C. · HRA Pharma · Jiaxing Maternity and Child Health Care Hospital · Massachusetts General Hospital · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Nova Southeastern University · Santa Clara Valley Medical Center · University of California, Davis · University of California, San Diego · University of California, San Francisco · Women's Hospital School Of Medicine Zhejiang University · Amsterdam UMC, location VUmc · Anhui Province Cancer Hospital · Anhui Provincial Hospital · Antonia New · Assistance Publique - Hôpitaux de Paris · Astellas Pharma US, Inc. · Beth Israel Deaconess Medical Center · Bharatpur Eye Hospital · BioPro Medical Ltd · Breast Cancer Research Foundation · Brigham and Women's Hospital · Bronx Veterans Medical Research Foundation, Inc · CREHPA · Canisius-Wilhelmina Hospital · Center for Information and Counseling on Reproductive Health - Tanadgoma · Center for Research on Environment, Health and Population Activities · Centre de Formation et de la Recherche, Tunisia · Charitable Foundation Women Health & Family Planning · Charles Drew University of Medicine and Science · Check, Jerome H., M.D., Ph.D. · Chelsea and Westminster NHS Foundation Trust · Children's Investment Fund Foundation · China Resources Zizhu Pharmaceutical Co., Ltd. · Christiaan Vinkers · Clinical Hospital Merkur · Dana-Farber Cancer Institute · Daniel Grossman · Daniel Grossman, MD · Dartmouth-Hitchcock Medical Center · Eli Lilly and Company · First Affiliated Hospital of Wenzhou Medical University · Georgetown University · Grand Challenges Canada · Gynecologic Oncology Group · HaEmek Medical Center, Israel · Hadassah Medical Organization · Healthy Life · Hopital La Rabta · Hospital Provincial Magdalena V. de Martínez · Huzhou Maternity and Child Care Hospital · Ibis Reproductive Health · Icahn School of Medicine at Mount Sinai · Indiana University · Innovatiefonds Zorgverzekeraars · Institute for the Study of Aging (ISOA) · Instituto de Biología y Medicina Experimental (IBYME-CONICET) · James J. Peters Veterans Affairs Medical Center · Jinhua Municipal Central Hospital · Johns Hopkins University · KIST Medical College · KIST Medical College and Teaching Hospital · Kaiser Permanente · Kathmandu Medical College and Teaching Hospital · Kathmandu Model Hospital · Leiden University Medical Center · Lumbini Provincial Hospital · all 139 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) MIFEPREX — 2016-03-29 fda.gov ↗
Approved US (FDA) MIFEPREX — 2000-09-28 fda.gov ↗

Trials 141 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT06616077 Jun 2022 → Apr 2023 endometrial disorder, progesterone resistance Reproductive Health Research Insritute, Chile Completed No outcome recorded
Phase 0 NCT05151016 Dec 2021 → Dec 2023 adenomyosis Women's Hospital School Of Medicine Zhejiang University Unknown No outcome recorded
Phase 0 NCT01138553 Jun 2010 → Jun 2014 ductal breast carcinoma in situ, invasive breast carcinoma University of California, San Diego Terminated No outcome recorded Stop: Enrollment
Phase 115 trials
Phase 1 NCT06502158 Oct 2024 → Oct 2026 expected — Montefiore Medical Center Recruiting No outcome recorded
Phase 1 NCT04254627 Sep 2021 → Sep 2025 persian gulf syndrome Nova Southeastern University Completed No outcome recorded
Phase 1 NCT04255498 Oct 2017 → Aug 2019 occupational disorder, persian gulf syndrome South Florida Veterans Affairs Foundation for Research and Education Unknown No outcome recorded
Phase 1 NCT03258372 Aug → Nov 2017 — Corcept Therapeutics Completed No outcome recorded
Phase 1 NCT03259542 Aug → Dec 2017 — Corcept Therapeutics Completed No outcome recorded
Phase 1 NCT03508635 Sep 2014 → Dec 2015 — Corcept Therapeutics Completed No outcome recorded
Phase 1 NCT02099825 Jan 2014 → Oct 2022 anxiety disorder Washington University School of Medicine Terminated No outcome recorded
Phase 1 NCT02014337 Jan 2014 → Dec 2017 breast cancer, malignant epithelial tumor of ovary, non-small cell lung carcinoma, prostate cancer +2 Corcept Therapeutics Completed No outcome recorded
Phase 1 NCT02046421 Nov 2013 → May 2018 fallopian tube carcinoma, male breast carcinoma, malignant epithelial tumor of ovary, primary peritoneal carcinoma University of Chicago Completed No outcome recorded
Phase 1 NCT01988610 Oct 2013 → Feb 2017 depressive disorder Stanford University Completed No outcome recorded
Phase 1/25 trials · 3 missed
Phase 1/2 NCT02012296 Dec 2013 → Jun 2019 hormone-resistant prostate carcinoma University of Chicago Completed Missed primary
Phase 1/2 NCT01333098 Sep 2012 → Apr 2013 anxiety disorder Washington University School of Medicine Completed No outcome recorded
Phase 1/2 NCT01419535 Nov 2011 → Nov 2015 diabetes mellitus Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Completed Missed primary
Phase 1/2 NCT00721201 Nov 2008 → Mar 2010 Cushing syndrome Sheffield Teaching Hospitals NHS Foundation Trust Completed No outcome recorded
Phase 1/2 NCT00099645 ? → Aug 2005 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 229 trials · 2 missed
Phase 2 NCT06689254 Nov 2024 → Sep 2026 overdue post-traumatic stress disorder Christiaan Vinkers Recruiting No outcome recorded
Phase 2 NCT06099769 Oct 2023 → Oct 2027 expected breast cancer Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT05177510 Aug 2023 → Dec 2026 expected — Chelsea and Westminster NHS Foundation Trust Recruiting No outcome recorded
Phase 2 NCT05217758 Dec 2021 → Aug 2024 major depressive disorder Amsterdam UMC, location VUmc Completed No outcome recorded
Phase 2 NCT04588688 May → Aug 2021 secondary adrenal insufficiency Tobias Else Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT04676776 Jan → Dec 2021 — Gynuity Health Projects Unknown No outcome recorded
Phase 2 NCT03972358 Feb 2020 → Dec 2021 menstrual disorder Gynuity Health Projects Unknown No outcome recorded
Phase 2 NCT03714880 Apr 2019 → Feb 2021 — University of California, Davis Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03225547 Feb 2018 → Sep 2025 triple-negative breast carcinoma University of Chicago Terminated No outcome recorded
Phase 2 NCT02788981 Mar 2017 → Dec 2022 overdue breast cancer University of Chicago Active not recruiting No outcome recorded
Phase 2/37 trials · 1 met primary · 1 missed
Phase 2/3 NCT06492889 Jul 2024 → Jun 2025 overdue pregnancy disorder Gynuity Health Projects Not yet recruiting No outcome recorded
Phase 2/3 NCT03520439 May 2018 → Jul 2019 adenomyosis xinmei zhang Completed Met primary
Phase 2/3 NCT02271958 Nov 2010 → Oct 2013 endometriosis Mediterranea Medica S. L. Completed No outcome recorded
Phase 2/3 NCT01786226 Mar 2010 → Mar 2012 uterine benign neoplasm Mediterranea Medica S. L. Terminated No outcome recorded
Phase 2/3 NCT00886873 May 2008 → Apr 2009 uterine benign neoplasm Mediterranea Medica S. L. Completed No outcome recorded
Phase 2/3 NCT00712595 Jan 2007 leiomyoma Mediterranea Medica S. L. Completed No outcome recorded
Phase 2/3 NCT00725270 Apr 1998 → May 2009 major depressive disorder, psychotic disorder Stanford University Terminated Missed primary Stop: Business
Phase 321 trials
Phase 3 NCT07506512 Jul 2027 → Jul 2031 expected pregnancy loss, recurrent, 4 University of Pennsylvania Not yet recruiting No outcome recorded
Phase 3 NCT06394999 May 2025 → Jun 2027 expected — Leiden University Medical Center Active not recruiting No outcome recorded
Phase 3 NCT05016349 Aug → Oct 2021 female breast carcinoma Mahmoud Ramadan mohamed Elkazzaz Unknown No outcome recorded
Phase 3 NCT03269279 May 2017 → Dec 2019 — Gynuity Health Projects Unknown No outcome recorded
Phase 3 NCT02985229 Oct 2016 → Jul 2017 — Gynuity Health Projects Completed No outcome recorded
Phase 3 NCT01925092 Aug 2013 → Dec 2016 Cushing disease due to pituitary adenoma Corcept Therapeutics Withdrawn No outcome recorded Stop: Enrollment
Phase 3 NCT01795599 May 2013 → Feb 2015 — Assistance Publique Hopitaux De Marseille Unknown No outcome recorded
Phase 3 NCT01436279 Jul 2011 → Aug 2013 — Boston University Completed No outcome recorded
Phase 3 NCT00957346 Feb 2011 → Jan 2012 — Gynuity Health Projects Terminated No outcome recorded
Phase 3 NCT01371565 Nov 2010 → Jun 2012 Cushing disease due to pituitary adenoma Corcept Therapeutics Completed No outcome recorded
Phase 434 trials · 3 met primary · 2 missed
Phase 4 NCT07671989 Jun → Dec 2026 expected menstrual disorder University of California, San Francisco Recruiting No outcome recorded
Phase 4 NCT05772169 Mar 2023 → Nov 2024 Cushing syndrome, type 2 diabetes mellitus Corcept Therapeutics Completed Met primary
Phase 4 NCT05119439 Oct 2022 → Jun 2023 — Gynuity Health Projects Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT05322252 Jul 2022 → Jun 2025 pregnancy disorder with abortive outcome, preterm premature rupture of the membranes Washington University School of Medicine Completed No outcome recorded
Phase 4 NCT05124314 Oct 2021 → Oct 2023 — Clinical Hospital Merkur Unknown No outcome recorded
Phase 4 NCT05046041 Nov 2020 → Aug 2021 — Gynuity Health Projects Completed No outcome recorded
Phase 4 NCT04458558 Jun 2020 → Apr 2021 pregnancy disorder Center for Information and Counseling on Reproductive Health - Tanadgoma Unknown No outcome recorded
Phase 4 NCT03913104 Jan 2020 → Jul 2023 pregnancy disorder Daniel Grossman, MD Completed No outcome recorded
Phase 4 NCT03829696 Jan 2020 → Jan 2021 — University of California, San Francisco Withdrawn No outcome recorded
Phase 4 NCT04063904 Oct 2019 → Apr 2020 — Gynuity Health Projects Terminated No outcome recorded Stop: Enrollment
Phase not applicable27 trials · 8 met primary · 1 missed
— NCT05898321 Jun 2023 → Dec 2024 submucous uterine fibroid Women's Hospital School Of Medicine Zhejiang University Unknown No outcome recorded
— NCT05049980 Nov 2021 → Feb 2022 — University Hospital, Toulouse Completed No outcome recorded
— NCT03440866 Mar 2018 → Dec 2021 — HaEmek Medical Center, Israel Unknown Missed primary
— NCT03043014 Jun 2017 → Mar 2019 — Assistance Publique Hopitaux De Marseille Completed Met primary
— NCT02679092 Apr 2016 → Feb 2020 — Stanford University Withdrawn No outcome recorded Stop: Business
— NCT02651844 Apr 2016 → Oct 2019 breast cancer Hospital Provincial Magdalena V. de Martínez Completed Met primary
— NCT01862991 Jul 2013 → Jun 2016 — Stanford University Completed No outcome recorded
— NCT01811056 Apr 2013 → Jul 2014 — Gynuity Health Projects Completed No outcome recorded
— NCT01636063 Jun 2012 → May 2014 — Boston University Terminated No outcome recorded Stop: Enrollment
— NCT01615731 May 2012 → Jun 2013 — Stanford University Completed No outcome recorded
Comparator or background therapy32 trials
Phase 0 NCT03248713 Comparator Nov 2017 → May 2019 nicotine dependence Yale University Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT00579475 Comparator Nov 2004 → Jun 2007 benign neoplasm of corpus uteri Karolinska Institutet Completed No outcome recorded
Phase 1/2 NCT03774745 Background Feb → Jul 2019 — University of California, Davis Terminated No outcome recorded
Phase 1/2 NCT02989662 Comparator Sep 2017 → Jan 2024 alcohol-related disorders Johns Hopkins University Completed No outcome recorded
Phase 1/2 NCT02243709 Comparator Sep 2014 → Dec 2021 alcohol-related disorders Brown University Completed No outcome recorded

News releases announcing trial results or a regulatory action · 11

DateIssuerRelease
2026-06-06 Corcept Therapeutics Results Corcept Presents New Data at ADA: Improved Outcomes in Patients Receiving a GLP-1 with Difficult-to-Control Type 2 Diabetes and Hypercortisolism Treated with Korlym® corcept.com ↗
2025-06-23 Corcept Therapeutics Results Corcept Presents Data from Treatment Phase of CATALYST Trial at American Diabetes Association’s 85th Scientific Sessions with Simultaneous Publication in Diabetes Care corcept.com ↗
Patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c (HbA1c), which decreased 1.47 percent from baseline, compared to a 0.15 percent decrease in patients who received placebo (p-value: < 0.001).
2024-12-12 Corcept Therapeutics Results Corcept Announces Positive Results in Treatment Phase of CATALYST Trial in Patients With Hypercortisolism (Cushing’s Syndrome) and Difficult-to-Control Diabetes corcept.com ↗
CATALYST met its primary endpoint.
2019-04-18 Corcept Therapeutics Results Corcept Therapeutics to Present Data at the 2019 American Association of Clinical Endocrinologists’ 28th Annual Congress corcept.com ↗
Mifepristone Provides Beneficial Clinical Improvement in Two Cushing Disease Cases in a Community Endocrinology Practice
2019-03-20 Corcept Therapeutics Results Corcept Therapeutics Announces Poster Presentations at the 2019 Annual Meeting of the Endocrine Society Meeting corcept.com ↗
Sustained Clinical Improvement after Discontinuation of Mifepristone: Unexpected Remission of Hypercortisolism
2016-12-10 Corcept Therapeutics Results Corcept Therapeutics Announces Encouraging Results of Phase 1/2 Trial of Mifepristone Plus Eribulin in Triple-Negative Breast Cancer corcept.com ↗
Four patients exhibited a partial response, defined as a 30 percent or greater reduction in tumor size, eight had stable disease and 11 had progressive disease.
2016-06-02 Corcept Therapeutics Results Corcept Therapeutics Provides Update of Progress in Cortisol Modulation Oncology Program corcept.com ↗
Preliminary efficacy results in Phase 1/2 trial of mifepristone plus eribulin (Eisai’s Halaven®) to treat triple-negative breast cancer (TNBC) indicate combination is active; final results expected in mid-2016
2015-12-14 Corcept Therapeutics Results Corcept Therapeutics Announces Initial Efficacy Results in Phase 1/2 Trial of Mifepristone in Combination With Eribulin for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer corcept.com ↗
At SABCS, the trial's investigators presented efficacy data from the 15 patients enrolled to-date with GR-positive TNBC who have been treated with the recommended dose (two patients from the trial's first phase and 13 from its second).
2015-05-14 Corcept Therapeutics Results Corcept Therapeutics Announces Poster Presentations on Mifepristone for the Treatment of Patients with Cushing’s Syndrome at the 27th Annual American Association of Clinical Endocrinologists corcept.com ↗
Mifepristone re-established glycemic control in a Cushing’s syndrome patient that relapsed after a 21 month interruption
2015-05-13 Corcept Therapeutics Results Corcept Therapeutics' Mifepristone Combined with Eribulin to Improve Antitumor Activity in Patients with Triple-Negative Breast Cancer corcept.com ↗
today announced results of a multi-center Phase 1/2 dose-escalation study of mifepristone and chemotherapy drug eribulin (Halaven®) that show it is well tolerated and clinically active in patients with triple-negative breast cancer.
2014-05-07 Corcept Therapeutics Results Corcept Therapeutics Announces First Quarter 2014 Financial Results corcept.com ↗
The company also reported that it is discontinuing its Phase 3 psychotic depression study (Study 14) based on the recommendation of the study's data monitoring committee that the study was unlikely to meet its primary endpoint with statistical significance.

All press releases naming this drug 16 releases

DateIssuerRelease

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 174 sources stand behind the page.

FieldValueCited text
Known as Mifépristone “Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E” NCT03134183 ↗
172

“This mixed-methods study follows a prospective cohort of participants receiving Mifeprex® (mifepristone) by a clinician in advance of a potential unintended pregnancy.” NCT03829696 ↗

“Participants were randomized to receive cervical priming with 200 mg of oral mifepristone 36 hours or 400 micrograms buccal misoprostol 3 hours before surgery.” PMID 33957651 ↗ Jun 2021

“the recommended use of mifepristone or misoprostol as cervical preparation for the abortions after 12 weeks” NCT01795599 ↗

“The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol.” NCT01387256 ↗

“The antiprogesterone, mifepristone, is one of the most promising drugs that have been tested.” NCT00579475 ↗

“Administration of oral Mifepristone 600 mg and oral Misoprostol 400 mcg concomitantly.” NCT03440866 ↗

“mifepristone (200mg orally) followed 24-48 hours later by misoprostol” NCT07174856 ↗

“oral administration of mifepristone 200 mg” NCT00945997 ↗

“Mifépristone versus Misoprostol” NCT03043014 ↗

“Mifepristone” NCT00359125 ↗

Show 162 more sources

Known as C-1073 “The purpose of this study is to evaluate the effects of C-1073 (Mifepristone) on cognition in patients with Alzheimer's disease (AD) who are also taking an acetylcholinesterase...” NCT00105105 ↗
Known as Corlux “Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol.” NCT00146523 ↗
4

“Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol.” NCT00208156 ↗

“Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol.” NCT00128479 ↗

“Corlux (mifepristone) is a new medication” NCT00128505 ↗

“CORLUX (TM) (Mifepristone)” NCT00752843 ↗

Known as Korlym “Mifepristone 300 MG [Korlym]” NCT05772169 ↗
1

“Korlym (mifepristone)” NCT01548417 ↗

Known as Medicane “Medicane (mifepristone)” NCT00554177 ↗
Known as MFP “Mifepristone (MFP) is currently used for medical abortion and for the treatment of Cushing disease.” NCT02651844 ↗
Known as Mifegyne “Mifepristone (Mifegyne) 50 mg every other day for 3 months” NCT00579475 ↗
3

“mifepristone, 50 mg (Mifegyne, Exelgyn, Paris, France)” NCT01898312 ↗

NCT05049980 ↗

NCT00920465 ↗

Known as Mifeprex “Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit” NCT03320057 ↗
1

NCT03829696 ↗

Known as MifeprexⓇ “Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.” NCT03913104 ↗
Known as Mifepristone tablets “Mifepristone tablets is developed by the China Resources Zizhu Pharmaceutical Co., Ltd.” NCT03210324 ↗
Known as Mifepristone, RU486 “Mifepristone, RU486” NCT06733727 ↗
Known as RU-486 “the purpose of this study is to determine the anti-HIV activity and safety of 3 different doses of mifepristone (also known as VGX-410 and RU486) in HIV infected people.” NCT00099645 ↗
6

“evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder.” NCT00725270 ↗

“Mifepristone, also known as RU-486, is a well-tolerated competitive progesterone receptor antagonist.” NCT05322252 ↗

“Mifepristone (RU-486) in Androgen Independent Prostate Cancer” NCT00140478 ↗

“mifepristone (RU-486), a glucocorticoid receptor antagonist” NCT00043654 ↗

“mifepristone (RU-486)” NCT00359125 ↗

“Mifepristone (RU-486)” NCT00867360 ↗

Known as VGX-410 “the purpose of this study is to determine the anti-HIV activity and safety of 3 different doses of mifepristone (also known as VGX-410 and RU486) in HIV infected people.” NCT00099645 ↗
1

“two doses of orally administered mifepristone (VGX-410) (300 and 600 mg)” NCT00352911 ↗

Action Inhibit “a glucocorticoid receptor antagonist” NCT00043654 ↗
Modality Small molecule “a 19 norsteroid with anti-progesterone and anti glucocorticoid activity” NCT03015701 ↗
Route Oral “Mifepristone 5 MG capsule taken once daily by mouth” NCT00133705 ↗