Active Ingredient History
Mifepristone is a synthetic steroid with antiprogestational effects indicated for the medical termination of intrauterine pregnancy through 49 days' pregnancy. Doses of 1 mg/kg or greater of mifepristone have been shown to antagonize the endometrial and myometrial effects of progesterone in women. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins. Mifepristone also exhibits antiglucocorticoid and weak antiandrogenic activity. The activity of the glucocorticoid dexamethasone in rats was inhibited following doses of 10 to 25 mg/kg of mifepristone. Doses of 4.5 mg/kg or greater in human beings resulted in a compensatory elevation of adrenocorticotropic hormone (ACTH) and cortisol. The anti-progestational activity of mifepristone results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species (mouse, rat, rabbit and monkey), the compound inhibits the activity of endogenous or exogenous progesterone. The termination of pregnancy results. In the treatment of Cushing's syndrome, Mifepristone blocks the binding of cortisol to its receptor. It does not decrease cortisol production but reduces the effects of excess cortisol, such as high blood sugar levels. Mifepristone is used 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. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Pregnancy, Unwanted (approved 2000)
Abortion Applicants (Phase 4)
Abortion, Induced (Phase 4)
Abortion, Missed (Phase 4)
Abortion, Spontaneous (Phase 3)
Abortion, Therapeutic (Phase 4)
Adenomyosis (Phase 2/Phase 3)
Adrenal Insufficiency (Phase 2)
Adrenocorticotropic Hormone (Phase 2)
Adverse Childhood Experiences (Phase 2)
Affective Disorders, Psychotic (Phase 3)
Alcoholism (Phase 2)
Alzheimer Disease (Phase 2)
Anxiety Disorders (Phase 4)
Bipolar Disorder (Phase 2)
Body Weight (Phase 2)
Borderline Personality Disorder (Phase 2)
Breast Neoplasms (Phase 3)
Breast Neoplasms, Male (Phase 1)
Carcinoma, Intraductal, Noninfiltrating (Early Phase 1)
Carcinoma, Non-Small-Cell Lung (Phase 2)
Carcinoma, Transitional Cell (Phase 1)
Central Serous Chorioretinopathy (Phase 2)
Cervix Uteri (Phase 3)
Cocaine-Related Disorders (Phase 2/Phase 3)
Cortisone (Phase 4)
Cushing Syndrome (Phase 4)
Delivery, Obstetric (Phase 3)
Depression (Phase 3)
Depressive Disorder (Phase 3)
Depressive Disorder, Major (Phase 3)
Dermatology (Phase 3)
Diabetes Mellitus (Phase 1/Phase 2)
Diabetes Mellitus, Type 2 (Phase 4)
Drug Interactions (Phase 1)
Endocrine System Diseases (Phase 1/Phase 2)
Endometrial Neoplasms (Phase 2)
Endometriosis (Phase 2/Phase 3)
Fallopian Tube Neoplasms (Phase 2)
Fetal Death (Phase 4)
Gestational Age (Phase 4)
Glucocorticoids (Phase 2)
Gulf War (Phase 4)
Hamartoma (Phase 2)
Healthy Volunteers (Phase 2)
Hepatitis C, Chronic (Phase 2)
HIV Infections (Phase 2)
Insulin Resistance (Phase 2)
Labor, Induced (Phase 3)
Labor, Obstetric (Phase 1)
Leiomyoma (Phase 4)
Meningioma (Phase 3)
Menstrual Cycle (Phase 2)
Menstruation Disturbances (Phase 4)
Mifepristone (Phase 2)
Obstetric Labor, Premature (Phase 4)
Occupational Diseases (Phase 1)
Ovarian Neoplasms (Phase 2)
Persian Gulf Syndrome (Phase 1)
Pituitary ACTH Hypersecretion (Phase 3)
Pregnancy (Phase 4)
Pregnancy Complications (Phase 4)
Pregnancy, Unwanted (Phase 1/Phase 2)
Prostatic Neoplasms (Phase 2)
Psychotic Disorders (Phase 3)
Rupture, Spontaneous (Phase 4)
Sarcoma (Phase 1)
Steroids (Phase 2)
Stress Disorders, Post-Traumatic (Phase 4)
Tobacco Use Disorder (Early Phase 1)
Triple Negative Breast Neoplasms (Phase 2)
Uterine Diseases (Phase 4)
Uterine Hemorrhage (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
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