Mifepristone

Overview

Mifepristone is a progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary cushing syndrome. The two marketed forms of mifepristone are Mifeprex® (mifepristone 200mg) and Korlym™ (mifepristone 300mg). Currently under investigation for use in psychotic depression (phase 3 trials).

Indication

For the medical termination of intrauterine pregnancy through 49 days' pregnancy. Also 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 are not candidates for surgery or have had unsuccessful surgery.

Associated Conditions

Hyperglycemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage	2024/12/13	NCT06733727	Not Applicable	Not yet recruiting	The University of Hong Kong
REVERSE: Improving Treatment-resistant Post Traumatic Stress Disorder (PTSD) with Glucocorticoid Receptor (GR) Antagonism	2024/11/14	NCT06689254	Phase 2	Recruiting	Christiaan Vinkers
Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone	2024/09/27	NCT06616077	Early Phase 1	Completed	Reproductive Health Research Insritute, Chile
Mifepristone vs Misoprostol	2024/07/16	NCT06502158	Phase 1	Recruiting	Montefiore Medical Center
Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens	2024/07/09	NCT06492889	Phase 2	Not yet recruiting	Gynuity Health Projects
WOMEN&More: Efficacy, safety, and acceptability of mifepristone 50 mg once-weekly as a contraceptive	2025/02/28	2022-502694-41-00	Phase 3	Recruiting	Leiden University Medical Center
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer	2023/10/25	NCT06099769	Phase 2	Recruiting	Memorial Sloan Kettering Cancer Center
To Prevent Type I-II Myoma After TCRM Recurrence by Gonadotropin-releasing Hormone (GnRH )Analogues or Mifepristone	2023/06/12	NCT05898321	Not Applicable	Not yet recruiting	Women's Hospital School Of Medicine Zhejiang University
Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location	2023/05/03	NCT05839899	Phase 3	Recruiting	Planned Parenthood League of Massachusetts
Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)	2023/03/16	NCT05772169	Phase 4	Completed	Corcept Therapeutics

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Mifepristone	Actavis Pharma, Inc.	0591-4390	ORAL	300 mg in 1 1	2/1/2022
Mifepristone	GenBioPro, Inc.	43393-001	ORAL	200 mg in 1 1	3/30/2023
Korlym	Corcept Therapeutics Incorporated	76346-073	ORAL	300 mg in 1 1	12/20/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
MIFEGYNE TABLETS 200MG	Laboratoires MACORS	SIN15583P	TABLET	200mg	11/23/2018

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MIFEPRISTONE LINEPHARMA 200 MG TABLET	175671	MS Health Pty Ltd	Medicine	A	8/29/2012
MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 microgram tablet blister]	210574	MS Health Pty Ltd	Medicine	A	6/4/2014
MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 microgram tablet blister]	462239	MS Health Pty Ltd	Medicine	A	1/21/2025

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MIFEGYMISO	linepharma international limited	02444038	Tablet , Kit - Buccal , Oral	200 MG	1/10/2017
MIFISO	linepharma international limited	02533553	Tablet , Kit - Buccal , Oral	200 MG	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
MIFEGYNE 600 MG COMPRIMIDOS	Exelgyn	84219	COMPRIMIDO	Uso Hospitalario	Not Commercialized
MIFEPRISTONA LINEPHARMA 200 MG COMPRIMIDOS	Linepharma	77617	COMPRIMIDO	Uso Hospitalario	Commercialized
MIFEGYNE 200 mg COMPRIMIDOS	Exelgyn	62728	COMPRIMIDO	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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