Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mifepristone · 13 trials · 9 indications
Safety was assessed at all visits and adverse events were recorded.
Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.
Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit.
Depressive symptom severity in patients with CT-related depression, measured with the Inventory of Depressive Symptomatology - Self Report (IDS-SR, with a total score ranging from 0 to 84, where higher scores indicate higher severity of depressive symptoms)
Maximum (peak) plasma drug concentration (Cmax)
Area under the concentration-time curve from zero up to the last concentration above the lower limit of quantification of the assay (AUC0-tz)
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Maximum (peak) plasma drug concentration (Cmax)
Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)
| Arm | Type | Description |
|---|---|---|
| mifepristone | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| mifepristone 600 mg | EXPERIMENTAL | - |
| matching placebo | PLACEBO_COMPARATOR | - |
| mifepristone 300 mg | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| mifepristone 1200 mg | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | Mifepristone 300 MG, 1 tablet |
| Cohort 2 | EXPERIMENTAL | Mifepristone 1500 MG, 5 tablets |
| Arm 1 | EXPERIMENTAL | Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered. |
| Risperidone plus mifepristone | EXPERIMENTAL | risperidone plus mifepristone daily for 28 days |
| Risperidone plus mifepristone-matched placebo | PLACEBO_COMPARATOR | risperidone plus mifepristone-matched placebo daily for 28 days |
| Risperidone-matched placebo plus mifepristone | PLACEBO_COMPARATOR | risperidone-matched placebo plus mifepristone daily for 28 days |
| Name | Type | Description |
|---|---|---|
| Mifepristone | DRUG | mifepristone at doses from 300mg/day up to 1200mg/day |
| placebo | DRUG | - |
| mifepristone matched placebo | DRUG | daily for 7 days |
| mifepristone 600 mg | DRUG | mifepristone 600 mg daily for 7 days |
| mifepristone 1200 mg | DRUG | mifepristone 1200 mg daily for 7 days |
| matching placebo | DRUG | daily for 7 days |
| Mifepristone 300 MG | DRUG | mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days |
| Itraconazole 100 MG | DRUG | itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing |
| Risperidone | DRUG | risperidone daily for 28 days |
| Risperidone-matched placebo | DRUG | risperidone-matched placebo daily for 28 days |
| Mifepristone-matched placebo | DRUG | mifepristone-matched placebo daily for 28 days |
Inclusion Criteria: 1. Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies including: * Cushing's Disease that (more than one may apply) * has recurred after primary pituitary surgery * has persisted despite pituitary sur...
Mifepristone is being developed by Corcept Therapeutics for Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. It is a small molecule in Phase 3 clinical development for these endocrine and psychiatric conditions. The drug is investigational and has not been approved for these indications.
Corcept Therapeutics Incorporated (NASDAQ: CORT) is developing Mifepristone. The company is conducting clinical trials for the drug in indications including Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. Corcept Therapeutics is the developer of this investigational small molecule.
Mifepristone is in Phase 3 clinical development for Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. The drug is investigational and has not been approved by regulatory authorities for these indications. Corcept Therapeutics is conducting the clinical development program.
Mifepristone has completed five clinical trials. These include NCT00455442, a Phase 2 study in weight-gain prevention; NCT00698022, a Phase 1 study in healthy volunteers; NCT03258372 and NCT03259542, Phase 1 drug-drug interaction studies; and one additional completed trial. All trials are completed with no active studies ongoing.
Mifepristone is a small molecule that acts as a glucocorticoid receptor antagonist. By blocking the glucocorticoid receptor, it is being studied for its effects in Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. This mechanism is relevant to conditions involving cortisol dysregulation.
Mifepristone is the active ingredient in Korlym, a medication approved for Cushing's syndrome. However, the data provided does not specify whether the Mifepristone in development by Corcept Therapeutics is the same product as Korlym. The drug is being studied in Phase 3 trials for related indications.