Asset profile

relacorilant · Corcept (CORT)

Indication: platinum-resistant ovarian cancer
Also known as: relacorilant, relacorilant plus nab-paclitaxel, Lifyorli

Company

Corcept Therapeutics Inc is a commercial-stage pharmaceutical company engaged in the discovery and development of medications that treat severe metabolic, oncologic, and neuropsychiatric disorders by modulating the effect of the cortisol hormone. The company m…

Start live analysis of CORT Run 8-agent AI analysis

On the calendar

29

May 2026

May 29, 2026

155 days ago

Corcept to present ROSELLA Phase 3 data at ASCO 2026

Conference presentationOutcome not recordedCompany press release

~

Dec 2026

~ Dec 2026

relacorilant: Phase 2 trial NCT03604198 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

17

Dec 2026

Dec 17, 2026

in 47 days

Corcept resubmits relacorilant NDA for Cushing’s syndrome; PDUFA Dec 17, 2026

Rescheduled — was Jul 11, 2026

FDA decision (PDUFA)SEC 8-K

~

Sep 2027

~ Sep 2027

relacorilant: Phase 2 trial NCT07259317 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

01

Oct 2027

Oct 1, 2027

in 335 days

relacorilant: Phase 2 trial NCT05726292 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

~

Dec 2030

~ Dec 2030

relacorilant: Phase 2 trial NCT07763496 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Timeline

Newest first.

Oct 9, 2026

03:25 PM

relacorilant · NCT03604198 registry update

Trial registry changeClinicalTrials.gov

Sep 25, 2026

03:20 PM

relacorilant · NCT05257408 registry update

Trial registry changeClinicalTrials.gov1 update

Sep 18, 2026

12:00 PM

Corcept Receives Positive CHMP Opinion for Relacorilant + Nab-Paclitaxel in Platinum-Resistant Ovarian Cancer

EMA opinionCompany press release Open record

Jul 29, 2026

08:07 PM

Corcept resubmits relacorilant NDA for Cushing’s syndrome; PDUFA Dec 17, 2026

PDUFA date extendedSEC 8-K Open record

Jun 17, 2026

08:36 PM

Corcept resubmits NDA for relacorilant in Cushing’s syndrome

Application submittedSEC 8-K Open record1 update

May 27, 2026

12:00 PM

Corcept to resubmit relacorilant NDA for Cushing’s syndrome

PDUFA date setCompany press release Open record

Apr 30, 2026

08:11 PM

Corcept: FDA approves Lifyorli (relacorilant) for platinum-resistant ovarian cancer

FDA approvalSEC 8-K Open record1 update

Apr 21, 2026

05:09 PM

Corcept to present ROSELLA Phase 3 data at ASCO 2026

Conference presentationCompany press release

Mar 25, 2026

12:00 AM

Corcept Therapeutics Inc. · FDA approves Lifyorli (relacorilant)

FDA approvalFDA Novel Drug Approvals Open record

Feb 24, 2026

09:10 PM

Corcept: relacorilant NDA in PROC has July 11, 2026 PDUFA

PDUFA date extendedSEC 8-K Open record

Jan 22, 2026

01:10 PM

Corcept: ROSELLA Phase 3 meets OS endpoint for relacorilant in platinum-resistant ovarian cancer

Topline resultsSEC 8-K Open record1 update

Dec 31, 2025

07:51 PM

Corcept receives CRL for relacorilant in hypercortisolism

Complete response letterSEC 8-K Open record

Nov 4, 2025

09:08 PM

Corcept: relacorilant NDA PDUFA set for Dec 30, 2025

PDUFA date setSEC 8-K Open record

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Oct 26, 2026

Primary endpoint metFavourable

Corcept: ROSELLA Phase 3 meets OS endpoint for relacorilant in platinum-resistant ovarian cancer

Overall survival significant or trendingMixed

88% vs 82% vs 77%; 91%

US / Western patient shareFavourable

197 of 394 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedConcern

Corcept resubmits relacorilant NDA for Cushing’s syndrome; PDUFA Dec 17, 2026

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentConcern

Corcept receives CRL for relacorilant in hypercortisolism

Related companies

Each relationship is backed by the filing that stated it.

The GOG Foundation, Inc. (GOG-F) Not US-listedPartner

European Network of Gynaecological Oncological Trial groups (ENGOT) Not US-listedPartner

Asia-Pacific Gynecologic Oncology Trials Group (APGOT) Not US-listedPartner

Latin American Cooperative Oncology Group (LACOG) Not US-listedPartner

Australia New Zealand Gynaecological Oncology Group (ANZGOG) Not US-listedPartner

CORTCorceptOwner

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT03604198	Phase 2	Active, not recruiting	Dec 1, 2026	125	25 of 48 sites in the United States
NCT04329949	Phase 3	Terminated	Aug 23, 2021	43	18 of 18 sites in the United States
NCT04308590	Phase 3	Completed	Sep 19, 2024	137	22 of 45 sites in the United States
NCT03776812	Phase 2	Completed	Mar 16, 2021	178	12 of 24 sites in the United States
NCT05257408	Phase 3	Active, not recruiting	Mar 31, 2025	381	44 of 116 sites in the United States
NCT07763496	Phase 2	Not yet recruiting	Dec 1, 2030	63	0 of 2 sites in the United States
NCT02762981	Phase 1/2	Completed	May 12, 2020	85	4 of 4 sites in the United States
NCT07259317	Phase 2	Recruiting	Sep 1, 2027	80	20 of 20 sites in the United States
NCT05726292	Phase 2	Recruiting	Oct 1, 2027	90	4 of 4 sites in the United States
NCT03697109	Phase 3	Completed	Apr 8, 2024	152	32 of 64 sites in the United States
NCT06906341	Phase 2	Recruiting	Aug 1, 2026	270	16 of 49 sites in the United States

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relacorilant · Corcept (CORT) — FDA Timeline & Readiness Checklist | SimianX AI