Corcept reports survival benefit in ALS trial of dazucorilant despite missing primary endpoint
Ella Day | June 9, 2025 | News story | Research and Development | Corcept Therapeutics, European Network to Cure ALS (ENCALS), Neurology, amyotrophic lateral sclerosis, clinical trial
Corcept Therapeutics has announced results from its phase 2 DAZALS study investigating dazucorilant in patients with amyotrophic lateral sclerosis (ALS), presented at the European Network to Cure ALS (ENCALS) 2025 annual meeting.
Although the trial did not meet its primary endpoint of functional improvement, measured by the ALS functional rating scale-revised, dazucorilant showed a significant survival benefit. No deaths occurred among patients receiving the higher 300mg dose over 24 weeks, compared to five deaths in the placebo group. This trend was reinforced in a one-year exploratory analysis, where patients on the 300mg dose continued to show significantly improved overall survival.
“The improvement in overall survival, first noted in the DAZALS study at six months, continues to be seen at one year,” said Leonard van den Berg, principal investigator. “This finding deserves our full attention in service to patients with this tragic disease.”
Corcept is now engaging with regulatory authorities in the US and Europe to determine the best path forward for dazucorilant. The treatment, which modulates cortisol activity, has demonstrated a satisfactory safety profile, with most side effects being mild or moderate.
ALS is a degenerative neurological disease with limited treatment options. It causes muscles to weaken and, as the disease progresses, severely impairs patients’ ability to speak, eat, move and breathe. Patient life expectancy after diagnosis is two to five years.
Corcept is continuing to investigate dazucorilant in an ongoing extension study and hopes that the observed survival benefit could lead to a new therapeutic option for patients. The company develops therapeutics focused on cortisol modulation and is currently conducting trials in patients with hypercortisolism, solid tumors, ALS and liver disease.
Ella Day
9/6/25
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