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 an investigational small molecule being studied for use in breast cancer, weight-gain prevention, Cushing's disease, Cushing's syndrome, and major depressive disorder. It is in Phase 3 clinical development for Cushing's syndrome, with additional trials exploring its use in other conditions.
Mifepristone works by blocking the effects of cortisol and other glucocorticoids at the receptor level. It is a glucocorticoid receptor antagonist, which means it binds to the receptor and prevents cortisol from activating it, potentially reducing the harmful effects of excess cortisol in conditions like Cushing's syndrome.
Mifepristone is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CORT. The company is focused on therapies that modulate the effects of cortisol and other steroid hormones.
Mifepristone is in Phase 3 clinical development for Cushing's syndrome, based on a completed Phase 3 trial. It remains investigational and has not been approved by the FDA for any indication. Other trials for different conditions are in Phase 1.
Mifepristone has been studied in five completed clinical trials. Notable trials include NCT00936741, a Phase 3 extension study in Cushing's syndrome, and NCT02014337, a Phase 1 study in metastatic triple negative breast cancer and other solid tumors. Other trials include NCT00698022 and NCT03258372 in healthy volunteers.
Yes, Mifepristone is also known as CORLUX. The Phase 3 extension study NCT00936741 is titled 'An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome,' confirming that CORLUX is an alternative name for Mifepristone.