Page updated ·next FDA decision on the calendar·Data as of Oct 13, 2026 8:08 PM ET
What the FDA said the last time · this application (NDA 219398) received a Complete Response Letter with an action date of December 30, 2025 (the FDA's letter, PDF, released under FDA's CRL transparency program). The letter's own section headings, read against the PDF:
Clinical and statistical: substantial evidence of effectiveness. The two phase 3 trials do not demonstrate effectiveness for the proposed indication. CORT125134-455 met its primary endpoint but in a highly enriched population: of 102 subjects with baseline hypertension, 40 (39%) discontinued during the open-label phase and only 46 (45%) entered the randomized-withdrawal phase, so the observed effect 'likely overestimates the treatment effect'. CORT125134-456 did not meet its primary endpoint (between-arm difference in 24-hour systolic blood pressure -0.85 mmHg, 95% CI -6.7 to 4.9, p = 0.77); a post-hoc subgroup analysis was not pre-specified, was small, had substantial missing data, and did not reach nominal significance under FDA's own imputation. FDA states it had told the sponsor at pre-submission meetings to expect significant review issues.
Benefit-risk assessment: drug-induced liver injury. With effectiveness not demonstrated, no final benefit-risk assessment could be made. FDA's safety review concluded relacorilant is associated with drug-induced liver injury: four cases assessed as probable DILI, one with an ALT of 1,952 U/L (more than 50 times the upper limit of normal), with no alternative etiology identified.
The application under review is Corcept's resubmission of this NDA, with a PDUFA goal date of December 17, 2026. The letter is the FDA's statement of what the resubmission has to answer.
This states what the FDA wrote; it is not a view on the resubmission's outcome.