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 the treatment of Amyotrophic Lateral Sclerosis (ALS). It is also being evaluated in clinical trials involving healthy adults and participants with hepatic impairment to assess its pharmacokinetics and safety.
Dazucorilant is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CORT.
Dazucorilant is in Phase 2 clinical development for Amyotrophic Lateral Sclerosis. It is also being studied in Phase 1 trials for healthy adults and hepatic impairment. The drug is investigational and has not been approved by regulatory authorities.
Dazucorilant is being studied in a Phase 2 trial (NCT05407324) for Amyotrophic Lateral Sclerosis with 279 participants across multiple countries. Two Phase 1 trials have been completed: NCT06495944 in healthy adults and NCT06928779 in participants with hepatic impairment.
Yes, Dazucorilant is also known as Dazucorilant 300 mg. This alternative name refers to the same investigational drug being developed by Corcept Therapeutics for Amyotrophic Lateral Sclerosis.
Dazucorilant is not FDA approved. It is an investigational drug currently in clinical development, with a Phase 2 trial for Amyotrophic Lateral Sclerosis that is still recruiting participants.