Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CORT113176
Dazucorilant · 4 trials · 4 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. |
| Study Participants | EXPERIMENTAL | On Day 1, participants will receive a single oral dose of \[14C\]-CORT113176 450 mg (3 X 150 mg lipid formulation capsules) in the fed state. |
| Cohort 1: CORT113176 150 mg | EXPERIMENTAL | Participants will receive CORT113176 150 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. |
| Cohort 1: Placebo matching CORT113176 | PLACEBO_COMPARATOR | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
| Cohort 2: CORT113176 300 mg | EXPERIMENTAL | Participants will receive CORT113176 300 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Progression from Cohort 1 to 2 will be done based on safety and tolerability outcome from Cohort 1 and only after Cohort 1 has received study drug for ≥7 days. |
| Cohort 2: Placebo matching CORT113176 | PLACEBO_COMPARATOR | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
| Cohort 3: CORT113176 ≥300 mg | EXPERIMENTAL | Participants will receive CORT113176 ≥300 mg not to exceed 450 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Cohort 3 is optional, and progression from Cohort 2 to 3 be done based on safety and tolerability outcome from Cohort 2 and only after Cohort 2 has received study drug for ≥7 days. |
| Cohort 3: Placebo matching CORT113176 | PLACEBO_COMPARATOR | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
| 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. |
| [14C]-CORT113176 | DRUG | \[14C\]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C. |
| CORT113176 | DRUG | CORT113176 lipid capsule formulation for oral administration |
| Placebo matching CORT113176 | DRUG | Placebo matching CORT113176 lipid capsule formulation 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 being studied as a treatment for amyotrophic lateral sclerosis (ALS), a progressive neurological disease. It is also being evaluated in hepatic impairment to understand how liver function affects the drug's pharmacokinetics. It is an investigational therapy and has not been approved for any indication.
Dazucorilant targets the glucocorticoid receptor (GR). By modulating GR activity, it is designed to influence pathways associated with neurodegeneration and stress responses. This mechanism is being explored in ALS, where glucocorticoid receptor signaling may contribute to disease progression.
Dazucorilant is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded on the Nasdaq under the ticker CORT. Corcept specializes in drugs that modulate the glucocorticoid receptor.
Dazucorilant is in Phase 2 clinical development for amyotrophic lateral sclerosis. A Phase 1 trial in hepatic impairment has been completed. The drug remains investigational and has not received FDA approval for any indication.
Dazucorilant has been studied in two clinical trials. The Phase 2 trial NCT05407324 evaluates Dazucorilant in patients with ALS and is active but not recruiting, with 279 participants across multiple countries. The completed Phase 1 trial NCT06928779 assessed the effects of hepatic impairment on the drug's pharmacokinetics in 19 participants.