MedPath

Mifepristone

Generic Name
Mifepristone
Brand Names
Korlym, Mifegymiso
Drug Type
Small Molecule
Chemical Formula
C29H35NO2
CAS Number
84371-65-3
Unique Ingredient Identifier
320T6RNW1F

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).

Background

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

Early Phase 1
Completed
Posted: 2024/09/27
Sponsor:
Reproductive Health ...
Phase 1
Recruiting
Posted: 2024/07/16
Phase 2
Not yet recruiting
Posted: 2024/07/09
Sponsor:
Gynuity Health Proje...

FDA Approved Products

Mifepristone
Manufacturer:Actavis Pharma, Inc.
Route:ORAL
Strength:300 mg in 1 1
Approved: 2022/02/01
NDC:0591-4390
Korlym
Manufacturer:Corcept Therapeutics Incorporated
Route:ORAL
Strength:300 mg in 1 1
Approved: 2023/12/20
NDC:76346-073
Mifepristone
Manufacturer:GenBioPro, Inc.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/03/30
NDC:43393-001

Singapore Approved Products

MIFEGYNE TABLETS 200MG
Manufacturer:Laboratoires MACORS
Form:TABLET
Strength:200mg
Online:Yes
Approved: 2018/11/23
Approval:SIN15583P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath