Relacorilant Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Relacorilant comprises 8 peer-reviewed publications across 6 journals, 5 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Fallopian Tube Neoplasms, Cushing Syndrome, and Prostatic Neoplasms. Most recent publication: 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., Lancet Diabetes Endocrinol, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Relacorilant plus nab-paclitaxel for recurrent, platinum-resistant ovarian cancer: a cost-effectiveness study.
    Zhou Y, Tong F, Jin B, et al. · J Gynecol Oncol · 2025
    PubMed: PMID 40051286 · NCT03776812 · Fallopian Tube Neoplasms
  2. Phase I/II Trial of Enzalutamide and Mifepristone, a Glucocorticoid Receptor Antagonist, for Metastatic Castration-Resistant Prostate Cancer.
    Serritella AV, Shevrin D, Heath EI, et al. · Clin Cancer Res · 2022
    PubMed: PMID 35110415 · NCT03674814 · Prostatic Neoplasms
  3. Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant.
    Pivonello R, Munster PN, Terzolo M, et al. · Front Endocrinol (Lausanne) · 2022
    PubMed: PMID 35058882 · NCT03697109 (GRACE) · Cushing Syndrome
  4. 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.
    Pivonello R, Arnaldi G, Auchus RJ, et al. · Lancet Diabetes Endocrinol · 2026
    PubMed: PMID 41730814 · NCT03697109 (GRACE) · Cushing Syndrome
  5. 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.
    Olawaiye AB, Kim JW, Bagameri A, et al. · J Gynecol Oncol · 2024
    PubMed: PMID 39032926 · NCT05257408 · Fallopian Tube Neoplasms
  6. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial.
    Olawaiye AB, Gladieff L, O'Malley DM, et al. · Lancet · 2025
    PubMed: PMID 40473448 · NCT05257408 · Fallopian Tube Neoplasms
  7. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial.
    Lorusso D, Gladieff L, O'Malley DM, et al. · Lancet · 2026
    PubMed: PMID 41974149 · NCT05257408 · Fallopian Tube Neoplasms
  8. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study.
    Colombo N, Van Gorp T, Matulonis UA, et al. · J Clin Oncol · 2023
    PubMed: PMID 37364223 · NCT05257408 · Fallopian Tube Neoplasms

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT03697109
GRACE
Cushing SyndromeNumber of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.
OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase
Placebo (RW Phase)27 Participants
Relacorilant (OL Phase)147 Participants
Relacorilant (RW Phase)23 Participants
NCT03697109
GRACE
Cushing SyndromeNumber of Patients With Loss of Response With Respect to Hypertension During the RW Phase.
Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Placebo (RW Phase)3 Participants
Placebo (RW Phase)1 Participants
Placebo (RW Phase)7 Participants
Placebo (RW Phase)1 Participants
Placebo (RW Phase)3 Participants
Placebo (RW Phase)4 Participants
Relacorilant (RW Phase)3 Participants
Relacorilant (RW Phase)1 Participants
Relacorilant (RW Phase)2 Participants
Relacorilant (RW Phase)3 Participants
Relacorilant (RW Phase)0 Participants
Relacorilant (RW Phase)2 Participants
NCT04308590
GRADIENT
Cushing SyndromeChange in Average 24-hour SBP
Baseline and Week 22
Placebo-2.89 mm Hg
Relacorilant-5.56 mm Hg
NCT04308590
GRADIENT
Cushing SyndromeNumber of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.
Baseline and up to Week 26
Placebo60 Participants
Relacorilant67 Participants
NCT04329949
RELIANT
Pancreatic NeoplasmsObjective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Baseline and up to 32 weeks
Relacorilant With Nab-paclitaxel0 Participants
Relacorilant With Nab-paclitaxel0 Participants
Relacorilant With Nab-paclitaxel43 Participants

Publications by year

2022–2026: 8 publications.

2022
2
2023
1
2024
1
2025
2
2026
2

Publications by indication

Fallopian Tube Neoplasms (5)

  • Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial.
    Lancet · 2026 · PMID 41974149 · NCT05257408
  • Relacorilant plus nab-paclitaxel for recurrent, platinum-resistant ovarian cancer: a cost-effectiveness study.
    J Gynecol Oncol · 2025 · PMID 40051286 · NCT03776812
  • Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial.
    Lancet · 2025 · PMID 40473448 · NCT05257408
  • 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.
    J Gynecol Oncol · 2024 · PMID 39032926 · NCT05257408
  • Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study.
    J Clin Oncol · 2023 · PMID 37364223 · NCT05257408

Cushing Syndrome (2)

  • 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.
    Lancet Diabetes Endocrinol · 2026 · PMID 41730814 · NCT03697109
  • Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant.
    Front Endocrinol (Lausanne) · 2022 · PMID 35058882 · NCT03697109

Prostatic Neoplasms (1)

  • Phase I/II Trial of Enzalutamide and Mifepristone, a Glucocorticoid Receptor Antagonist, for Metastatic Castration-Resistant Prostate Cancer.
    Clin Cancer Res · 2022 · PMID 35110415 · NCT03674814

Publications by journal

  • J Gynecol Oncol2 papers
  • Lancet2 papers
  • Clin Cancer Res1 paper
  • Front Endocrinol (Lausanne)1 paper
  • Lancet Diabetes Endocrinol1 paper
  • J Clin Oncol1 paper

Trial-results highlights

In studies of Relacorilant for Cushing Syndrome, treatment-emergent adverse events (TEAEs) were reported. In the open-label (OL) phase of the GRACE study (NCT03697109), TEAEs were observed in 147 participants in the Relacorilant arm. During the randomized withdrawal (RW) phase of the same study, TEAEs were reported in 27 participants in the placebo arm and 23 participants in the Relacorilant arm. For the GRADIENT study (NCT04308590), TEAEs were observed in 67 participants in the Relacorilant arm and 60 participants in the placebo arm. Regarding blood pressure, NCT04308590 (GRADIENT) reported a change in average 24-hour systolic blood pressure (SBP) from baseline to Week 22 of -5.56 mm Hg for the Relacorilant arm and -2.89 mm Hg for the placebo arm.

Also in the randomized withdrawal phase of NCT03697109 (GRACE), the number of participants with loss of response with respect to hypertension was assessed at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase). For the placebo arm, the reported numbers of participants with loss of response were:

  • 3 participants
  • 1 participant
  • 7 participants
  • 1 participant
  • 3 participants
  • 4 participants

For pancreatic neoplasms, the objective response rate (ORR) per blinded independent central review (BICR) was assessed in the RELIANT study (NCT04329949) from baseline and up to 32 weeks for the Relacorilant with nab-paclitaxel arm. The number of participants with an objective response was reported as:

  • 0 participants
  • 0 participants
  • 43 participants

All values presented are sourced from primary registry reporting, and individual papers should be consulted for clinical decisions.

All Relacorilant publications (8)

2026 (2 papers)

  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.
    Pivonello R, Arnaldi G, Auchus RJ, et al. · Lancet Diabetes Endocrinol · 2026 · Derived
    PubMed: PMID 41730814 · NCT03697109 (GRACE) · Cushing Syndrome
  2. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial.
    Lorusso D, Gladieff L, O'Malley DM, et al. · Lancet · 2026 · Derived
    PubMed: PMID 41974149 · NCT05257408 · Fallopian Tube Neoplasms

2025 (2 papers)

  1. Relacorilant plus nab-paclitaxel for recurrent, platinum-resistant ovarian cancer: a cost-effectiveness study.
    Zhou Y, Tong F, Jin B, et al. · J Gynecol Oncol · 2025 · Derived
    PubMed: PMID 40051286 · NCT03776812 · Fallopian Tube Neoplasms
  2. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial.
    Olawaiye AB, Gladieff L, O'Malley DM, et al. · Lancet · 2025 · Derived
    PubMed: PMID 40473448 · NCT05257408 · Fallopian Tube Neoplasms

2024 (1 paper)

  1. 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.
    Olawaiye AB, Kim JW, Bagameri A, et al. · J Gynecol Oncol · 2024 · Derived
    PubMed: PMID 39032926 · NCT05257408 · Fallopian Tube Neoplasms

2023 (1 paper)

  1. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study.
    Colombo N, Van Gorp T, Matulonis UA, et al. · J Clin Oncol · 2023 · Derived
    PubMed: PMID 37364223 · NCT05257408 · Fallopian Tube Neoplasms

2022 (2 papers)

  1. Phase I/II Trial of Enzalutamide and Mifepristone, a Glucocorticoid Receptor Antagonist, for Metastatic Castration-Resistant Prostate Cancer.
    Serritella AV, Shevrin D, Heath EI, et al. · Clin Cancer Res · 2022 · Derived
    PubMed: PMID 35110415 · NCT03674814 · Prostatic Neoplasms
  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.
    Pivonello R, Munster PN, Terzolo M, et al. · Front Endocrinol (Lausanne) · 2022 · Derived
    PubMed: PMID 35058882 · NCT03697109 (GRACE) · Cushing Syndrome

Sources and methodology

  • Publications: ctgov.study_references (PubMed PMIDs auto-attached by ClinicalTrials.gov to each trial), reference types RESULT, DERIVED, and BACKGROUND.
  • Per-arm outcome values: ctgov.outcome_measurements joined to ctgov.design_outcomes where outcome_type = 'PRIMARY', restricted to phase PHASE3 and PHASE2/PHASE3.
  • Publication metadata (title, journal, year, authors): PubMed E-utilities efetch.fcgi
  • Data freshness: Fri, 17 Jul 2026 03:59:51 GMT.
This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).