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Relacorilant

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Lifyorli

CORCEPT THERAPEUTICS INC CORT · Cushing Syndrome; Fallopian Tube Neoplasms; Hypercortisolism; Metastatic Pancreatic Ductal Adenocarcinoma; Ovarian Neoplasm

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Key figures

  • Next catalyst

    45

    days to go. PDUFA date,

  • Phase

    Approved

    Not recorded

  • Linked trials

    4

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    NDA220641,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
CORCEPT THERAPEUTICS INC CORT Source: Company record for CORCEPT THERAPEUTICS INC (opens in a new tab)
Indications
Cushing Syndrome; Fallopian Tube Neoplasms; Hypercortisolism; Metastatic Pancreatic Ductal Adenocarcinoma; Ovarian Neoplasm Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Applications
NDA 220641 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 220641 (opens in a new tab)
NDA 219398 Source: openFDA complete response letters (opens in a new tab) · Action letter for NDA 219398 (opens in a new tab)
Designations
None recorded
Next catalyst
PDUFA date, Source: 0001628280-26-050607 (opens in a new tab)

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 CompletedFirst trial start 15 Nov 20184 linked trials
  5. Filed Completed
  6. Approved Current stageFirst approval 25 Mar 2026

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

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  1. RelacorilantPDUFA

    · PDUFA date · CORCEPT THERAPEUTICS INC CORT

    CORCEPT THERAPEUTICS INC: PDUFA date in EX-99.1 (8-K) filed 29 July 2026

    Belanoff. Hypercortisolism (Cushing’s Syndrome) •Relacorilant for patients with Cushing’s syndrome – New Drug Application for relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026 •GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with Cushing’s syndrome – Results published in The Lancet Diabetes & Endocrinology (Pivonello et al, February 2026) •CATALYST and MOMENTUM – New data presented at American Diabetes Association’s (ADA) 86th Scientific Sessions in June “Our studies have shown that patients with hypercortisolism who receive relacorilant experience clinically and statistically significant improvements in the multiple signs and symptoms of the disease.

    Source: 0001628280-26-050607 (opens in a new tab)

    45days to go

FDA designations

No FDA designations are on record for Relacorilant. Editors add each one with its source.

Filed application

No filed application is on record for Relacorilant. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Relacorilant.

Clinical trials

Trials linked to Relacorilant
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT05257408ClinicalTrials.gov record for NCT05257408 (opens in a new tab)Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube CancerPhase 3Active, not recruiting381 (actual)31 Mar 2025 (actual) Yes First posted Results on ClinicalTrials.gov for NCT05257408 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT05257408

  • Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) (months)
    • Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 vs Nab-paclitaxel 100 mg/m^2: Hazard Ratio (HR) 0.70 (95% CI 0.54 to 0.91), p-value 0.0076, Log Rank, superiority
  • Overall Survival (months)
    • Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 vs Nab-paclitaxel 100 mg/m^2: Hazard Ratio (HR) 0.65 (95% CI 0.51 to 0.83), p-value 0.0004, Log Rank, superiority

Serious adverse events (All-cause Mortality: up to 32 months; Adverse Events: up to 25 months): Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 66 of 188; Nab-paclitaxel 100 mg/m^2 45 of 190

Source: ClinicalTrials.gov results for NCT05257408 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing NCT05257408 (4), newest first

  1. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial.

    Lancet (London, England) · 2026 Apr 18

    PubMed 41974149 (opens in a new tab)DOI 10.1016/S0140-6736(26)00462-9 (opens in a new tab)

  2. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial.

    Lancet (London, England) · 2025 Jun 21

    PubMed 40473448 (opens in a new tab)DOI 10.1016/S0140-6736(25)01040-2 (opens in a new tab)

  3. Clinical Trial Protocol for ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer.

    Journal of gynecologic oncology · 2024 Jul

    PubMed 39032926 (opens in a new tab)DOI 10.3802/jgo.2024.35.e111 (opens in a new tab)

  4. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 Oct 20

    PubMed 37364223 (opens in a new tab)DOI 10.1200/JCO.22.02624 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT04308590ClinicalTrials.gov record for NCT04308590 (opens in a new tab)GRADIENTA Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal AdenomasPhase 3Completed137 (actual)19 Sep 2024 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04308590 (opens in a new tab)

Posted results on ClinicalTrials.gov for GRADIENT

  • Change in Average 24-hour SBP (mm Hg)
    • Relacorilant vs Placebo: Least squares mean difference -2.67 (95% CI -9.096 to 3.766), p-value 0.4160, Mixed Models Analysis, equivalence

Serious adverse events (Up to Week 26): Relacorilant 15 of 68; Placebo 4 of 69

Source: ClinicalTrials.gov results for NCT04308590 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

NCT04329949ClinicalTrials.gov record for NCT04329949 (opens in a new tab)RELIANTStudy of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal AdenocarcinomaPhase 3Terminated43 (actual)23 Aug 2021 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04329949 (opens in a new tab)

Posted results on ClinicalTrials.gov for RELIANT

Serious adverse events (Up to 30 days after the last dose of study treatment (up to 73 weeks)): Relacorilant With Nab-paclitaxel 23 of 43

Source: ClinicalTrials.gov results for NCT04329949 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

NCT03697109ClinicalTrials.gov record for NCT03697109 (opens in a new tab)GRACEA Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing SyndromePhase 3Completed152 (actual)8 Apr 2024 (actual) Yes First posted Results on ClinicalTrials.gov for NCT03697109 (opens in a new tab)

Posted results on ClinicalTrials.gov for GRACE

  • Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. (Participants)
    • Relacorilant (RW Phase) vs Placebo (RW Phase): Odds Ratio (OR) 0.17 (95% CI 0.04 to 0.77), p-value 0.0215, Chi-squared, equivalence

Serious adverse events (OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase.): Relacorilant (OL Phase) 29 of 152; Relacorilant (RW Phase) 5 of 30; Placebo (RW Phase) 1 of 32

Source: ClinicalTrials.gov results for NCT03697109 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing GRACE (2), newest first

  1. Efficacy and safety of relacorilant for the treatment of patients with Cushing's syndrome (GRACE): a multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study.

    The lancet. Diabetes & endocrinology · 2026 Apr

    PubMed 41730814 (opens in a new tab)DOI 10.1016/S2213-8587(25)00362-6 (opens in a new tab)

  2. Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant.

    Frontiers in endocrinology · 2021

    PubMed 35058882 (opens in a new tab)DOI 10.3389/fendo.2021.793262 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Relacorilant, newest first
ApplicationActionDateOutcomeReviewSource
NDA220641Action letter for NDA220641 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
NDA219398Action letter for NDA219398 (opens in a new tab) Original 20260128 Complete Response letterComplete response letterNot givenopenFDA complete response letters (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

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EU status (EMA)

OpinionOrphan medicine

Lifyorli (EMEA/H/C/006731)

Authorised
Not given
Therapeutic area
Fallopian Tube Neoplasms;Peritoneal Neoplasms;Carcinoma, Ovarian Epithelial
Marketing authorisation holder
Corcept Therapeutics Netherlands B.V.
Active substance (INN)
relacorilant

Matched by active substance: EMA's INN or active substance equals this drug's name.

EMA page for Lifyorli (opens in a new tab)EMA medicine data (opens in a new tab)

Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.

Related news

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Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.