Corcept's Phase 2 DAZALS Study Shows Dazucorilant Provides 87% Reduction in Mortality Risk Over Two Years in ALS Patients
Phase 2 DAZALS study enrolled 249 ALS patients randomized to 150 mg dazucorilant, 300 mg dazucorilant, or placebo for 24 weeks, followed by open-label extension with 300 mg.
Did not meet primary endpoint of slowing ALSFRS-R decline, but showed improved survival.
Two-year data:
87% reduction in risk of death (HR 0.13, p<0.0001) for 300 mg dazucorilant vs. placebo (no extension).
One-year:
84% reduction (HR 0.16, p=0.0009).
For patients on 300 mg >24 weeks:
61% reduction at two years (HR 0.39, p=0.02) vs. placebo/150 mg.
Acceptable safety profile; 92% adverse events mild/moderate, mainly GI issues.
Corcept plans Phase 3 study later this year after regulator discussions.
Data announced April 30, 2026, building on ENCALS 2025 presentation.