FDA Approved Drugs » 2012
Medical Areas: Endocrinology | Family Medicine

View By:Year | Company | Conditions | Therapeutic Areas | Drug Names

Korlym (mifepristone)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Corcept Therapeutics
Approval Status: Approved February 2012
Treatment Area: hyperglycemia in adults with endogenous Cushing’s syndrome

General Information

Korlym (mifepristone) is a small-molecule progesterone and glucocorticoid antagonist. It 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.

Korlym was specifically approved to control hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing's syndrome who have type II diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.

Korlym is supplied as a tablet for oral administration. The recommended initial dose is a single dose of 300 mg orally once daily. The daily dose of Korlym may be increased in 300 mg increments. The dose of Korlym may be increased to a maximum of 1200 mg once daily but should not exceed 20 mg/kg per day. Increases in dose should not occur more frequently than once every 2-4 weeks.

Clinical Results

FDA Approval
The FDA approval of Korlym was based on an uncontrolled, open-label, 24-week, multicenter clinical study. The study enrolled 50 subjects with clinical and biochemical evidence of hypercortisolemia despite prior surgical treatment and radiotherapy. The subjects were placed in one of two cohorts: a diabetes cohort and a hypertension cohort and were evaluated separately. Korlym treatment was started at a dose of 300 mg once a day. The study protocol allowed an increase in dose to 600 mg after two weeks, and then by additional 300 mg increments every four weeks to a maximum of 900 mg per day for patients <60 kg, or 1200 mg per day for patients >60 kg.
Diabetes Cohort
The primary efficacy analysis for the diabetes cohort was an analysis of responders. A responder was defined as a subject who had a ≥25% reduction from baseline in glucose AUC. Fifteen of 25 subjects (60%) were treatment responders.
Hypertension Cohort
There were no changes in mean systolic and diastolic blood pressures at the end of the trial relative to baseline.

Side Effects

Adverse events associated with the use of Korlym may include, but are not limited to, the following:

  • nausea
  • fatigue
  • headache
  • decreased blood potassium
  • arthralgia
  • vomiting
  • peripheral edema
  • hypertension
  • dizziness
  • decreased appetite
  • endometrial hypertrophy

Mechanism of Action

Korlym (mifepristone) is a small-molecule progesterone and glucocorticoid antagonist. It is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor. In addition, mifepristone appears to have little or no affinity for estrogen, muscarinic, histaminic, or monoamine receptors.

Additional Information

For additional information regarding Korlym or hyperglycemia in adults with endogenous Cushing’s syndrome, please visit the Corcept web page.

 

 

 

 

Bipolar World   1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010
Owners:  Allie Bloom, David Schafer, M.Ed. (Blackdog)

Partners:  John Haeckel, Judith (Duff)
Founder:  Colleen Sullivan
Email Us at Bipolar World


About Us  Add a Link  Advance Directives  Alternative Treatments  Ask the Doctor   Ask Dr. Plyler about Bipolar Disorder   Ask The Doctor/Topic Archives  Awards  Benny the Bipolar Puppy  Bipolar Chat  Bipolar Children  Bipolar Disorder News  Bipolar Help Contract  Bipolar World Forums  Book Reviews  Bookstore  BP & Other mental Illness   Clinical Research Trials & FDA Drug Approval   Community Support   Contact Us  The Continuum of Mania and Depression   Coping   Criteria    Criteria and Diagnosis  Criteria-World Health Disabilities,  DSMV-IV   Dual Diagnosis  eGroups  Expressions (Poetry, Inspiration, Humor, Art Gallery, Memorials  Family Members   Getting Help for a Loved One who Refuses Treatment  Greeting Cards  History of Mental Illness  Indigo  Job and School  Links    Medications   Medication and Weight Gain    News of the Day  Parent Chat  Pay for Meds  Personal Stories  Self Help  Self Injury  Significant Others  Stigma and Mental Health Law  Storm's Column  Suicide!!!  The Suicide Wall  Table of Contents  Treatments  Treatment Compliance  US Disability  Veteran's Chat  What's New?