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Placebo-matching Mifepristone
Mifepristone is a glucocorticoid receptor antagonist that blocks cortisol signaling to modulate stress-related memory and emotional processing.
Mifepristone is a glucocorticoid receptor antagonist that blocks cortisol signaling to modulate stress-related memory and emotional processing. Used for Prevention of post-traumatic stress disorder (PTSD) in acute trauma survivors (investigational).
At a glance
| Generic name | Placebo-matching Mifepristone |
|---|---|
| Sponsor | Roger K. Pitman, MD |
| Drug class | Glucocorticoid receptor antagonist |
| Target | Glucocorticoid receptor (GR) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | FDA-approved |
Mechanism of action
Mifepristone competitively antagonizes glucocorticoid receptors, preventing cortisol from exerting its downstream effects on the hypothalamic-pituitary-adrenal (HPA) axis and brain regions involved in fear conditioning and trauma memory consolidation. By blocking glucocorticoid signaling during or shortly after trauma exposure, it may reduce the formation or consolidation of traumatic memories and associated emotional responses. This mechanism has been investigated for prevention of post-traumatic stress disorder (PTSD) when administered in the acute post-trauma period.
Approved indications
- Prevention of post-traumatic stress disorder (PTSD) in acute trauma survivors (investigational)
Common side effects
- Nausea
- Fatigue
- Dizziness
- Adrenal insufficiency risk
Key clinical trials
- Mifepristone for the Prevention of Relapses of Alcohol Drinking (PHASE1, PHASE2)
- Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus (PHASE2)
- Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation (PHASE4)
- A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers (PHASE1)
- Non-surgical Alternatives to Treatment of Failed Medical Abortion (PHASE4)
- Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults (PHASE1, PHASE2)
- S9005 Mifepristone in Meningioma (PHASE3)
- CORT125134 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo-matching Mifepristone CI brief — competitive landscape report
- Placebo-matching Mifepristone updates RSS · CI watch RSS
- Roger K. Pitman, MD portfolio CI