Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dazucorilant · 3 trials · 3 indications
This outcome measure is assessed in study Part 1.
This outcome measure is assessed in study Part 1.
This outcome measure is assessed in study Part 2.
This outcome measure is assessed in study Part 2.
| Arm | Type | Description |
|---|---|---|
| Part 1: CORT113176 (Dazucorilant) 300 mg | EXPERIMENTAL | 300 mg of dazucorilant will be administered once daily. |
| Part 1: CORT113176 (Dazucorilant) 150 mg | EXPERIMENTAL | 150 mg of dazucorilant will be administered once daily. |
| Part 1: Placebo (matched to study drug) | PLACEBO_COMPARATOR | Placebo will be administered once daily. |
| Part 2: CORT113176 (Dazucorilant) 75 - 300 mg Dose-titration | EXPERIMENTAL | 75 mg of dazucorilant will be administered once daily for 1 week, and increased weekly in 75 mg increments up to 300 mg once daily. |
| Moderate Hepatic Impairment | EXPERIMENTAL | On Day 1, each participant with moderate hepatic impairment will receive a single oral dose of dazucorilant 300 mg. |
| Matched Healthy Participants | EXPERIMENTAL | Healthy participants will be matched to those with moderate hepatic impairment as to gender, age (± 10 years of the mean), and weight (± 20% of the mean). On Day 1, each healthy participant will receive a single oral dose of dazucorilant 300 mg. |
| Mild Hepatic Impairment | EXPERIMENTAL | On Day 1, each participant with mild hepatic impairment will receive a single oral dose of dazucorilant 300 mg. This arm may be enrolled after review of interim PK evaluation of the effects of moderate hepatic impairment. |
| Dazucorilant (300 mg) and itraconazole (200 mg) | EXPERIMENTAL | On Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, in a fed state. On Days 5-11, all participants will be administered once daily, oral doses of itraconazole 200 mg, in a fed state. |
| Name | Type | Description |
|---|---|---|
| Dazucorilant 300 mg | DRUG | 300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule. |
| Dazucorilant 150 mg | DRUG | Dazucorilant and placebo will be administered once daily in 4 capsules, 2 capsules with 75 mg dazucorilant/capsule, and 2 capsules of placebo equivalent. |
| Placebo | OTHER | Placebo will be administered once daily in capsules of placebo equivalent. |
| Dazucorilant | DRUG | Dazucorilant will be administered once daily in 75-mg capsules. |
| Itraconazole | DRUG | 100 mg capsules for oral administration |
Inclusion Criteria: * Male and female patients ≥18 years of age with sporadic or familial ALS. In Part 1, patients must have a risk of ALS progression characterized by a European Network for the Cure of ALS (ENCALS) risk profile score ≥ -6 and ≤ -3. In Part 2 patients must have a risk of ALS progre...
Dazucorilant is an investigational small molecule being studied for amyotrophic lateral sclerosis (ALS). It is also being evaluated in healthy adults and in people with hepatic impairment for pharmacokinetic studies. The drug is in clinical development and is not approved by the FDA.
Dazucorilant targets the glucocorticoid receptor (GR). It is being developed by Corcept Therapeutics as a potential treatment for amyotrophic lateral sclerosis. The drug's mechanism involves modulating GR activity, though the specific effects in ALS are still under investigation.
Dazucorilant is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker CORT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in amyotrophic lateral sclerosis and other conditions.
Dazucorilant is in Phase 2 clinical development for amyotrophic lateral sclerosis. The Phase 2 trial is currently recruiting participants. The drug is also being studied in Phase 1 trials for hepatic impairment and healthy adults, which have been completed. Dazucorilant is not FDA approved.
Dazucorilant is being studied in a Phase 2 trial (NCT05407324) for amyotrophic lateral sclerosis, which is recruiting 279 participants across multiple countries. Two Phase 1 trials have been completed: NCT06928779 in hepatic impairment and NCT06495944 in healthy adults.