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pdufa.bio

Relacorilant

Updated ยทnext FDA decision on the calendar

Relacorilant is a Corcept Therapeutics Inc program in Cushing's syndrome (hypercortisolism). Its next catalyst is a Readout in Dec 2026. 2 FDA decisions on record below. Every date links its source.

CORT catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Relacorilant is marketed as Lifyorli (relacorilant); the events below include those tracked under the brand name. Indications under review: Cushing's syndrome (hypercortisolism); Platinum-resistant ovarian cancer. Sponsor: Corcept Therapeutics Inc (CORT). Review status: Corcept resubmitted the NDA for relacorilant in Cushing's syndrome in June 2026, after a December 2025 CRL, and states a PDUFA date of December 17, 2026 in its second-quarter release. Market-cap tier at the time we tracked it: Large. We track 5 catalyst events for this program: 2 upcoming and 3 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Dec 31, 2025 CRLCORTPDUFA · Mar 25, 2026 ✓ ApprovedCORTPDUFA · Jul 11, 2026CORTReadout · Dec 2026CORTPDUFA · Dec 17, 2026CORT

Questions

When is Relacorilant's next FDA decision or readout?

The next tracked catalyst for Relacorilant is a Readout in Dec 2026.

What happened at Relacorilant's most recent FDA decision?

On Mar 25, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is Relacorilant used for?

In our records Relacorilant is under review or in development for Cushing's syndrome (hypercortisolism); Platinum-resistant ovarian cancer.

Who makes Relacorilant?

Corcept Therapeutics Inc (CORT).

Has Relacorilant been approved by the FDA?

Yes. The FDA approved an application for Relacorilant on Mar 25, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.