Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate mifepristone, primarily focusing on reproductive health indications such as medical abortion, labor induction, and female contraception. Supported by academic institutions, foundation trusts, and pharmaceutical organizations, these studies also explore applications in central adrenal insufficiency, cocaine dependence, and BRCA1-associated malignancies including triple-negative breast and ovarian cancers. Trial statuses range across the development continuum, encompassing actively recruiting, completed, terminated, and withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07506512 NOT_YET_RECRUITING
Early Pregnancy Loss
University of Pennsylvania
 2026-07 PHASE3
NCT06733727 NOT_YET_RECRUITING
Silent Miscarriage
The University of Hong Kong
 2024-12-06
NCT06099769 RECRUITING
Metastatic Breast Cancer
Memorial Sloan Kettering Cancer Center
 2023-10-18 PHASE2
NCT06394999 ACTIVE_NOT_RECRUITING
Female Contraception
Leiden University Medical Center
 2025-05-02 PHASE3
NCT06502158 RECRUITING
Cervical Preparation
Montefiore Medical Center
 2024-10-31 PHASE1
NCT05177510 RECRUITING
Labor, Induced
Chelsea and Westminster NHS Foundation Trust
 2023-08-25 PHASE2
NCT07174856 NOT_YET_RECRUITING
Abortion, Medical
Ibis Reproductive Health
 2025-10-10 PHASE4
NCT07671989 RECRUITING
Menstrual Regulation; Menstrual Health Intervention
University of California, San Francisco
 2026-06-22 PHASE4
NCT06689254 RECRUITING
Treatment-resistant PTSD
Christiaan Vinkers
 2024-11-15 PHASE2
NCT07646275 COMPLETED
Early Pregnancy Loss; Abortion, Spontaneous; Miscarriage; Pregnancy, Unwanted
Harran University
 2025-04-01
NCT07604675 COMPLETED
Medication Abortion; Health Knowledge Attitudes and Practice; Pregnant People
University of California, San Francisco
 2025-01-15
NCT04254627 COMPLETED
Gulf War Illness
Nova Southeastern University
 2021-09-24 PHASE1
NCT03225547 TERMINATED
Triple Negative Breast Neoplasms; Breast Cancer
University of Chicago
 2018-02-12 PHASE2
NCT05341817 RECRUITING
Abortion in First Trimester
KK Women's and Children's Hospital
 2022-11-22 PHASE4
NCT06492889 UNKNOWN
Pregnancy Early; Pregnancy Related
Gynuity Health Projects
 2024-07-22 PHASE2; PHASE3
NCT05322252 COMPLETED
Abortion, Second Trimester; PPROM; Rupture, Spontaneous; Fetal Demise; Fetal Death; Fetal Demise From Miscarriage; Fetal Death Before 22 Weeks With Retention of Dead Fetus; Pregnancy Loss; Pregnancy Complications
Washington University School of Medicine
 2022-07-01 PHASE4
NCT05898321 UNKNOWN
Submucous Leiomyoma of Uterus
Women's Hospital School Of Medicine Zhejiang University
 2023-06-01
NCT05772169 COMPLETED
Hypercortisolism; Diabetes Mellitus, Type 2
Corcept Therapeutics
 2023-03-31 PHASE4
NCT06394999 Not yet recruiting
Female Contraception
Leiden University Medical Center|Karolinska Institutet|Women on Waves|Children''s Investment Fund Foundation
 2024-09 Phase 3
NCT05217758 COMPLETED
Major Depressive Disorder; Childhood Trauma
Amsterdam UMC, location VUmc
 2021-12-09 PHASE2
NCT05304273 COMPLETED
Miscarriage
Calcutta National Medical College and Hospital
 2022-05-05 PHASE3
NCT05839899 UNKNOWN
Abortion
Planned Parenthood League of Massachusetts
 2023-08-30 PHASE3
NCT02989662 COMPLETED
Alcohol Use Disorder
Johns Hopkins University
 2017-09-26 PHASE1; PHASE2
NCT05151016 UNKNOWN
Adenomyosis; Mifepristone
Women's Hospital School Of Medicine Zhejiang University
 2021-12-01 EARLY_PHASE1
NCT05124314 UNKNOWN
Abortion, Missed
Clinical Hospital Merkur
 2021-10-27 PHASE4
NCT03194126 COMPLETED
Medical; Abortion, Fetus
Centre Hospitalier Universitaire de Nīmes
 2018-02-11
NCT05177510 Recruiting
Labor Induced
Chelsea and Westminster NHS Foundation Trust
 2023-08-25 Phase 3
NCT03913104 COMPLETED
Abortion Early; Pregnancy Related
Daniel Grossman, MD
 2020-01-05 PHASE4
NCT05119439 TERMINATED
Medical Abortion
Gynuity Health Projects
 2022-10-07 PHASE4
NCT05097326 COMPLETED
Induced Vaginal Delivery
Stanford University
 2022-06-27 PHASE3
NCT06616077 COMPLETED
Endometrial Endocrine Regulation; Progesterone Supplementation in Women After Mifepristone
Reproductive Health Research Insritute, Chile
 2022-06-07 EARLY_PHASE1
NCT04271722 COMPLETED
Labor; Forced or Induced, Affecting Fetus or Newborn; Labor Onset and Length Abnormalities
Centro Hospitalar Lisboa Norte
 2020-01-15
NCT02788981 ACTIVE_NOT_RECRUITING
Breast Cancer
University of Chicago
 2017-03-28 PHASE2
NCT02099825 TERMINATED
Anxiety Disorders
Washington University School of Medicine
 2014-01-13 PHASE1
NCT04905251 Recruiting
Medical Abortion
Linepharma International LTD
 2022-02-22 --
NCT01898312 COMPLETED
Women With Mutations in the Breast Cancer Susceptibility Genes BRCA1,2
Karolinska Institutet
 2013-09 PHASE2
NCT03972358 UNKNOWN
Menstrual Regulation
Gynuity Health Projects
 2020-02-12 PHASE2
NCT03440866 UNKNOWN
Early Pregnancy
HaEmek Medical Center, Israel
 2018-03-01
NCT02243709 COMPLETED
Alcohol Use Disorders (AUD)
Brown University
 2014-09 PHASE1; PHASE2
NCT04676776 UNKNOWN
Missed Menstrual Period
Gynuity Health Projects
 2021-01-25 PHASE2
NCT05062174 Withdrawn
BRCA1 Mutation|High-grade Serous Ovarian Cancer|TNBC - Triple-Negative Breast Cancer
Indiana University|Breast Cancer Research Foundation
 2021-11-01 --
NCT05016349 UNKNOWN
Breast Cancer Female
Mahmoud Ramadan mohamed Elkazzaz
 2021-08 PHASE3
NCT05046041 COMPLETED
Abortion in Second Trimester
Gynuity Health Projects
 2020-11-25 PHASE4
NCT04588688 TERMINATED
Central Adrenal Insufficiency; Mifepristone
Tobias Else
 2021-05-05 PHASE2
NCT04588688 Terminated
Central Adrenal Insufficiency|Mifepristone
Tobias Else|Corcept Therapeutics|University of Michigan
 2021-05-05 Phase 2
NCT04458558 UNKNOWN
Abortion Early; Pregnancy Related
Center for Information and Counseling on Reproductive Health - Tanadgoma
 2020-06-30 PHASE4
NCT03052400 TERMINATED
Type 2 Diabetes Mellitus; Insulin Resistance
Charles Drew University of Medicine and Science
 2017-02-03 PHASE2
NCT03714880 TERMINATED
Second Trimester Abortion
University of California, Davis
 2019-04-26 PHASE2
NCT03829696 WITHDRAWN
Early Abortion
University of California, San Francisco
 2020-01 PHASE4
NCT02642939 TERMINATED
Non-Small Cell Lung Cancer (NSCLC)
Check, Jerome H., M.D., Ph.D.
 2015-12 PHASE2
NCT03320057 COMPLETED
Pregnancy Related; Abortion Early
Daniel Grossman
 2018-06-01 PHASE4
NCT04063904 TERMINATED
Second Trimester Abortion
Gynuity Health Projects
 2019-10-16 PHASE4
NCT02679092 WITHDRAWN
Legally Induced Abortion Without Mention of Complication
Stanford University
 2016-04
NCT03212352 TERMINATED
Early Pregnancy Failure
Radboud University Medical Center
 2018-06-27 PHASE4
NCT03065660 COMPLETED
Missed Miscarriage
University of Birmingham
 2017-09-20 PHASE3
NCT03269279 UNKNOWN
Medical; Abortion, Fetus
Gynuity Health Projects
 2017-05-20 PHASE3
NCT02179749 COMPLETED
Alcohol Dependence; Alcohol Use Disorders; Alcohol Abuse; Alcoholism
The Scripps Research Institute
 2014-09 PHASE2
NCT02651844 COMPLETED
Breast Cancer
Hospital Provincial Magdalena V. de Martínez
 2016-04
NCT02620904 TERMINATED
Intrauterine Fetal Demise; Fetal Death
Montefiore Medical Center
 2016-07-14 PHASE4
NCT04255498 UNKNOWN
Gulf War Illness; Persian Gulf Syndrome; Occupational Diseases
South Florida Veterans Affairs Foundation for Research and Education
 2017-10-30 PHASE1
NCT03520439 COMPLETED
Adenomyosis
xinmei zhang
 2018-05-19 PHASE2; PHASE3
NCT03774745 TERMINATED
Pregnancy, Unwanted
University of California, Davis
 2019-02-11 PHASE1; PHASE2
NCT02012296 COMPLETED
Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer
University of Chicago
 2013-12-13 PHASE1; PHASE2
NCT03248713 TERMINATED
Nicotine Dependence
Yale University
 2017-11-29 EARLY_PHASE1
NCT02704481 TERMINATED
Abortion Failure
Gynuity Health Projects
 2016-06-01 PHASE4
NCT03210324 TERMINATED
Uterine Fibroid
China Resources Zizhu Pharmaceutical Co., Ltd.
 2017-06-01 PHASE4
NCT03044093 UNKNOWN
Second Trimester Abortion
Rambam Health Care Campus
 2017-01 PHASE4
NCT03659045 Completed
Abortion-Related Disorders
Assistance Publique Hopitaux De Marseille
 2019-01-15 Not Applicable
NCT03346629 COMPLETED
Abortion in Second Trimester
Gynuity Health Projects
 2017-12-01 PHASE4
NCT02342002 TERMINATED
Missed Abortion; Pregnancy
Gynuity Health Projects
 2015-01 PHASE4
NCT02633761 TERMINATED
Fetal Death
Gynuity Health Projects
 2015-04-01 PHASE3
NCT01493310 COMPLETED
Male Breast Cancer; Recurrent Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
University of Chicago
 2011-11 PHASE1
NCT02046421 COMPLETED
Male Breast Cancer; Recurrent Breast Cancer; Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
University of Chicago
 2013-11 PHASE1
NCT03259542 COMPLETED
Drug Interaction Potentiation; Healthy
Corcept Therapeutics
 2017-08-09 PHASE1
NCT02014337 COMPLETED
Breast Cancer; Ovarian Epithelial Cancer Recurrent; Sarcoma; Non-small Cell Lung Cancer; Carcinoma, Transitional Cell; Prostate Cancer; Prostatic Neoplasms
Corcept Therapeutics
 2014-01 PHASE1
NCT03258372 COMPLETED
Healthy
Corcept Therapeutics
 2017-08-16 PHASE1
NCT03134183 COMPLETED
Abortion, Second Trimester
Virginia Commonwealth University
 2016-11-19 PHASE4
NCT02985229 COMPLETED
Medical Abortion
Gynuity Health Projects
 2016-10 PHASE3
NCT02981030 COMPLETED
Abortion, Therapeutic
Gynuity Health Projects
 2016-11-23 PHASE4
NCT02012491 COMPLETED
Spontaneous Abortion
University of Pennsylvania
 2014-01 PHASE3
NCT02354170 COMPLETED
Central Serous Chorioretinopathy
Roger Goldberg, M.D., MBA
 2015-01 PHASE2
NCT01988610 COMPLETED
Depression
Stanford University
 2013-10 PHASE1
NCT02745093 UNKNOWN
Medical Abortion
Ibis Reproductive Health
 2016-09 PHASE4
NCT02708446 UNKNOWN
Legally Induced Abortion Without Mention of Complication
Gynuity Health Projects
 2014-05 PHASE4
NCT01925092 WITHDRAWN
Cushing's Disease
Corcept Therapeutics
 2013-08 PHASE3
NCT01739335 COMPLETED
Stress Disorders, Post-Traumatic
VA Office of Research and Development
 2012-11-19 PHASE2
NCT01134198 COMPLETED
Cocaine Dependence
New York State Psychiatric Institute
 2010-05 PHASE2; PHASE3
NCT01212588 TERMINATED
Borderline Personality Disorder
Indiana University
 2010-09 PHASE2
NCT01990560 COMPLETED
Mild Hypercortisolism
Icahn School of Medicine at Mount Sinai
 2013-11 PHASE4
NCT01294319 COMPLETED
Cortisol Resistance; Negative Feedback; ACTH; Mineralcorticoid; Glucocorticoid
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2011-01-24 PHASE2
NCT01862991 COMPLETED
Legally Induced Abortion Without Mention of Complication
Stanford University
 2013-07
NCT02314754 COMPLETED
Medical Abortion
Gynuity Health Projects
 2014-12 PHASE4
NCT01931657 COMPLETED
Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena
Karolinska Institutet
 2013-08 PHASE2
NCT00832871 TERMINATED
Cancer
New Mexico Cancer Research Alliance
 2008-11
NCT03508635 COMPLETED
Healthy
Corcept Therapeutics
 2014-09 PHASE1
NCT01419535 COMPLETED
Endocrine Disease; Diabetes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2011-11-29 PHASE1; PHASE2
NCT01920022 COMPLETED
Early Pregnancy Termination; Medical Abortion; Postabortion Contraception
Karolinska Institutet
 2013-10 PHASE4
NCT00833339 UNKNOWN
Posttraumatic Stress Disorder
James J. Peters Veterans Affairs Medical Center
 2008-05 PHASE2
NCT01490697 COMPLETED
Post-traumatic Stress Disorder
Roger K. Pitman, MD
 2009-03 PHASE4
NCT01548417 COMPLETED
Alcoholism
The Scripps Research Institute
 2012-03 PHASE2
NCT01798017 COMPLETED
Menstrual Regulation
Gynuity Health Projects
 2012-11 PHASE4
NCT02720991 COMPLETED
Abortion, 3 Months
Gynuity Health Projects
 2014-07 PHASE4
NCT01795599 UNKNOWN
Surgical Abortion
Assistance Publique Hopitaux De Marseille
 2013-05 PHASE3
NCT01631682 COMPLETED
Posttraumatic Stress Disorder; Anxiety Disorder
Massachusetts General Hospital
 2010-11 PHASE4
NCT01811056 COMPLETED
Termination of Pregnancy
Gynuity Health Projects
 2013-04
NCT01138553 TERMINATED
Invasive Breast Cancer; Ductal Carcinoma in Situ
University of California, San Diego
 2010-06 EARLY_PHASE1
NCT00637494 TERMINATED
Psychotic Depression; Severe Major Depression With Psychotic Features; Psychosis
Corcept Therapeutics
 2008-03 PHASE3
NCT01768299 COMPLETED
Complete Uterine Evacuation After Use of Study Drugs
Gynuity Health Projects
 2013-02 PHASE4
NCT01636063 TERMINATED
Induced Abortion; Abortion Techniques; Mifepristone; Misoprostol
Boston University
 2012-06
NCT01751087 COMPLETED
Abortion, Induced
Planned Parenthood League of Massachusetts
 2013-01
NCT02412618 COMPLETED
Induced Abortion
Medstar Health Research Institute
 2012-09 PHASE4
NCT02271958 COMPLETED
Endometriosis
Mediterranea Medica S. L.
 2010-11 PHASE2; PHASE3
NCT01856985 COMPLETED
Medical Abortion
Gynuity Health Projects
 2013-04 PHASE4
NCT01436279 COMPLETED
Cervical Preparation
Boston University
 2011-07 PHASE3
NCT00969982 COMPLETED
Abortion, Induced
Gynuity Health Projects
 2009-06
NCT01615731 COMPLETED
Abortion, Induced
Stanford University
 2012-05
NCT01333098 COMPLETED
Anxiety Disorders
Washington University School of Medicine
 2012-09 PHASE1; PHASE2
NCT00864799 COMPLETED
Pregnancy
King Edward Memorial Hospital
 2009-04
NCT00936741 COMPLETED
Cushing's Syndrome
Corcept Therapeutics
 2009-07 PHASE3
NCT00691067 COMPLETED
Chronic Multisymptom Illness in Gulf War Veterans
Bronx Veterans Medical Research Foundation, Inc
 2008-05 PHASE4
NCT01475318 UNKNOWN
Complete Abortion
The University of Hong Kong
 2011-10
NCT00784797 COMPLETED
Abortion, Missed
Hadassah Medical Organization
 2009-01 PHASE4
NCT01371565 COMPLETED
Cushing's Disease; Cushing's Syndrome
Corcept Therapeutics
 2010-11 PHASE3
NCT00881140 COMPLETED
Uterine Fibroid; Vaginal Bleeding.
BioPro Medical Ltd
 2009-04 PHASE2
NCT00422201 TERMINATED
Cushing's Syndrome
HRA Pharma
 2007-05-15 PHASE2
NCT02398838 COMPLETED
Abortion, First Trimester
Gynuity Health Projects
 2009-12
NCT01786226 TERMINATED
Uterine Fibroids
Mediterranea Medica S. L.
 2010-03 PHASE2; PHASE3
NCT00997347 COMPLETED
Medical Abortion
Gynuity Health Projects
 2009-07 PHASE4
NCT00957346 TERMINATED
Abortion, Induced
Gynuity Health Projects
 2011-02 PHASE3
NCT01173003 COMPLETED
Induced Abortion
Gynuity Health Projects
 2009-06
NCT02219100 COMPLETED
Abortion, First Trimester
Gynuity Health Projects
 2010-11
NCT01156688 COMPLETED
Abortion, Legal
The University of Hong Kong
 2010-08 PHASE4
NCT00986921 COMPLETED
Abortion
Boston University
 2009-10
NCT00386282 COMPLETED
Abortion, First Trimester
Gynuity Health Projects
 2006-09
NCT00994734 COMPLETED
Termination of Pregnancy
Gynuity Health Projects
 2009-05
NCT00569582 COMPLETED
Cushing's Syndrome
Corcept Therapeutics
 2007-12 PHASE3
NCT00359125 WITHDRAWN
Bipolar Depression
University of British Columbia
 2006-07 PHASE2
NCT00459290 COMPLETED
Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
Gynecologic Oncology Group
 2007-05 PHASE2
NCT01387256 COMPLETED
Complete Abortion
Gynuity Health Projects
 2009-05 PHASE4
NCT00133705 COMPLETED
Leiomyoma
University of Rochester
 2003-07 PHASE3
NCT00592215 WITHDRAWN
Second Trimester Labor Induction
Johns Hopkins University
 2008-03 PHASE1
NCT00721201 COMPLETED
Subclinical Cushing's
Sheffield Teaching Hospitals NHS Foundation Trust
 2008-11 PHASE1; PHASE2
NCT00482209 COMPLETED
Induced Abortion
Gynuity Health Projects
 2007-05
NCT00784186 COMPLETED
Abortion, Induced
Gynuity Health Projects
 2008-08
NCT00725270 TERMINATED
Psychotic Disorders; Depressive Disorder, Major; Depressive Disorder
Stanford University
 1998-04 PHASE2; PHASE3
NCT00867360 TERMINATED
Affective Disorders, Psychotic; Depressive Disorder
Stanford University
 2005-08 PHASE3
NCT00886873 COMPLETED
Uterine Fibroids
Mediterranea Medica S. L.
 2008-05 PHASE2; PHASE3
NCT00870272 COMPLETED
Abortion, Induced
Gynuity Health Projects
 2007-07
NCT00698022 COMPLETED
Healthy
Corcept Therapeutics
 2008-11 PHASE1
NCT00285818 COMPLETED
Depression
Stanford University
 2003-01
NCT00468299 TERMINATED
Early Pregnancy Failure; Miscarriage; Fetal Demise; Anembryonic Pregnancy
Boston University
 2007-04
NCT00752843 COMPLETED
Healthy Subjects
Corcept Therapeutics
 2008-09 PHASE1
NCT00554177 COMPLETED
Post Traumatic Stress Disorder (PTSD)
Antonia New
 2007-09 PHASE1
NCT00410345 COMPLETED
Abortion, Missed
Hadassah Medical Organization
 2004-08 PHASE4
NCT00680394 COMPLETED
Pregnancy Termination
Gynuity Health Projects
 2007-07
NCT00286208 COMPLETED
Induced Abortion
Gynuity Health Projects
 2005-08
NCT00505739 COMPLETED
Endometrial Cancer
M.D. Anderson Cancer Center
 2001-09 PHASE2
NCT00255177 COMPLETED
Hepatitis C Virus Infection
VGX Pharmaceuticals, LLC
 2005-11 PHASE2
NCT00677755 COMPLETED
Emergency Contraception; Abortion, Induced
Taizhou Hospital
 2004-10
NCT00579475 COMPLETED
Uterine Fibroids
Karolinska Institutet
 2004-11 PHASE1
NCT00352911 COMPLETED
HIV Infections
VGX Pharmaceuticals, LLC
 2006-07 PHASE2
NCT00186056 COMPLETED
Depression
Stanford University
 2003-01
NCT00128479 COMPLETED
Major Depressive Disorder; Psychotic Disorders
Corcept Therapeutics
 2004-09 PHASE3
NCT00712595 COMPLETED
Uterine Fibroids
Mediterranea Medica S. L.
 2007-01 PHASE2; PHASE3
NCT00208156 COMPLETED
Depressive Disorder, Major
Corcept Therapeutics
 2005-05 PHASE3
NCT00382538 COMPLETED
Abortion, Induced; Abortion, Second Trimester
Boston University
 2005-03
NCT00128505 COMPLETED
Major Depressive Disorder; Psychotic Disorders
Corcept Therapeutics
 2005-08 PHASE3
NCT00190294 COMPLETED
Pregnancy Complications
Assistance Publique - Hôpitaux de Paris
 2003-04 PHASE4
NCT00146523 COMPLETED
Major Depressive Disorder
Corcept Therapeutics
 2005-05 PHASE3
NCT00130676 COMPLETED
Major Depressive Disorder; Psychotic Disorders
Corcept Therapeutics
 2004-09 PHASE3
NCT00140478 COMPLETED
Prostate Cancer; Adenocarcinoma of Prostate
Dana-Farber Cancer Institute
 2005-02 PHASE2
NCT00269568 COMPLETED
Abortion Seekers
University of Pittsburgh
 2004-06 PHASE4
NCT00105105 TERMINATED
Alzheimer's Disease
Corcept Therapeutics
 2003-04 PHASE2
NCT00177372 COMPLETED
Anembryonic Pregnancy; Gestation Abnormality; Intrauterine Fetal Demise Term
University of Pittsburgh
 2005-01 PHASE4
NCT00945997 COMPLETED
Termination of Pregnancy Second Trimester
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2000-10
NCT03015701 COMPLETED
Meningioma
SWOG Cancer Research Network
 1992-08 PHASE3
NCT00383032 COMPLETED
Abortion, Induced
Dartmouth-Hitchcock Medical Center
 2004-01
NCT00099645 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1; PHASE2
NCT00455442 COMPLETED
Weight-Gain Prevention
Corcept Therapeutics
 2007-03 PHASE2
NCT01224509 TERMINATED
Cervical Prostaglandin EP3 Receptors; Pregnancy
University of Southern California
 2004-09
NCT00043654 COMPLETED
Bipolar Disorder
National Institute of Mental Health (NIMH)
 2002-08-07 PHASE2
NCT00219778 TERMINATED
Leiomyoma
Poitiers University Hospital
 2004-12 PHASE2
NCT00386867 COMPLETED
Abortion, Induced
Gynuity Health Projects
 2006-10
NCT00330993 COMPLETED
Abortion, Induced
University of Pittsburgh
 2006-03 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-01)

Check the Mifepristone (RU-486) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mifepristone functions as a potent, competitive antagonist of both progesterone and glucocorticoid receptors, thereby inhibiting hormone-driven signal transduction, downregulating Bcl-2 expression, and promoting cellular autophagy and apoptosis. Consequently, this target blockade destabilizes progesterone-dependent uterine tissues and suppresses cell survival signaling, providing the mechanistic basis for its clinical utility in medical abortion, labor induction, and hormone-sensitive oncological conditions.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.