relacorilant (CORT125134) / Corcept Therap - LARVOL DELTA

Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Corcept Therapeutics

New P2 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CA 19-9

PHASE 3 ROSELLA (GOG-3073, ENGOT-OV72) TRIAL OF RELACORILANT + NAB-PACLITAXEL VS NAB-PACLITAXEL IN PLATINUM-RESISTANT OVARIAN CANCER: PRIMARY RESULTS AND OUTCOMES IN OLDER PATIENTS (IGCS 2025) - "The addition of relacorilant to nab-paclitaxel showed a statistically significant improvement in PFS by BICR and a clinically meaningful benefit in OS at the interim analysis (Table). Patients aged ≥65 were heavily pretreated, had advanced disease, and were similarly distributed between treatment arms (38.3% vs 41.5%). The addition of relacorilant was associated with a 39% reduction in the risk of progression in this subgroup (PFS by BICR: HR 0.61 [95% CI 0.40-0.94] P=0.0247)."

Clinical • Late-breaking abstract • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Clinical Development (Businesswire) - "(i) Cervical cancer - Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy) to begin in coming weeks, conducted in collaboration with ARCAGY-GINECO, an academic clinical research group specializing in gynecologic cancers; (ii) Pancreatic cancer - Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 50 patients with pancreatic cancer to begin in coming weeks."

New P2 trial • Cervical Cancer • Pancreatic Cancer

Marketing Authorization Application (MAA) (Businesswire) - "European Medicines Agency reviewing MAA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer – Approval expected by the end of next year."

EMA approval • Platinum resistant • Ovarian Cancer

Relacorilant in Combination with Chemotherapy (Businesswire) - "(i) BELLA Part A - Enrollment nearly complete in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-resistant ovarian cancer – Results expected by the end of next year; (ii) BELLA Part B - Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARP inhibitor to begin in coming weeks; (iii) BELLA Part C - Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy) to begin in coming weeks."

P2 data • Platinum resistant • Platinum sensitive • Trial status • Endometrial Cancer • Ovarian Cancer

ROSELLA…pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer (Businesswire) - "Final overall survival results expected by early next year."

P3 data • Platinum resistant • Ovarian Cancer

BELLA: A phase II study of relacorilant plus nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer (ESMO 2025) - P2 | "Legal entity responsible for the study Corcept Therapeutics Incorporated. Funding Corcept Therapeutics Incorporated."

Clinical • P2 data • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

BELLA: Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Corcept Therapeutics | N=90 ➔ 270

Enrollment change • Platinum resistant • Platinum sensitive • Endometrial Cancer • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

ROSELLA (GOG3073, ENGOTov72, APGOT-OV10): Relacorilant + nab-paclitaxel in the subgroup of patients with platinum-resistant ovarian cancer (PROC) previously exposed to a PARP inhibitor (ESMO 2025) - P3 | "Table: LBA45 Efficacy summary ITT Prior PARPi Relacorilant + nab-paclitaxel N=188 Nab-paclitaxel N=193 Relacorilant + nab-paclitaxel n=114 Nab-paclitaxel n=120 PFS (BICR) Events , n (%) 113 (60.1) 121 (62.7) 66 (57.9) 72 (60.0) Median , months 6.54 5.52 7.36 4.63 HR (95% CI) 0.70 (0.54-0.91) 0.60 (0.42-0.85) P-value (Log-rank) P=0.0076 Nominal P=0.0035 OS (Interim) Events , n (%) 82 (43.6) 110 (57.0) 51 (44.7) 65 (54.2) Median , months 15.97 11.50 15.61 12.58 HR (95% CI) 0.69 (0.52-0.92) 0.77 (0.53-1.13) P-value (Log-rank) P=0.0121 Nominal P=0.1834 Conclusions In patients with PROC previously exposed to a PARPi, relacorilant + nab-paclitaxel showed clinically meaningful improvements in PFS and OS. The median PFS of 7.36 months compares favorably to the median time from first to second subsequent therapy in patients who progressed while receiving a PARPi in the PAOLA1 trial (Ann Oncol 2025; 36:185) and supports further exploration of relacorilant to improve outcomes..."

Clinical • Late-breaking abstract • Platinum resistant • Gynecologic Cancers • Oncology • Ovarian Cancer

Targeting the glucocorticoid receptor as a therapeutic strategy for ovarian cancer: The ROSELLA study. (PubMed, Med) - "The ROSELLA trial tested the combination of intermittently dosed relacorilant, a novel glucocorticoid receptor antagonist, plus nab-paclitaxel versus nab-paclitaxel alone in recurrent platinum-resistant ovarian cancer (PROC).1 Interim results showed, for the combination, a 1-month improvement in median progression-free survival (PFS) and overall survival improvement versus single-agent nab-paclitaxel. Toxicities were higher in the combination arm versus single-agent nab-paclitaxel."

Clinical • Journal • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Corcept also announced the expansion of the recently initiated Phase 2 BELLA trial (Businesswire) - "...to three study arms to evaluate the efficacy and safety of: (i) relacorilant plus nab-paclitaxel and bevacizumab to treat patients with platinum-resistant ovarian cancer; (ii) relacorilant plus nab-paclitaxel and bevacizumab to treat patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARPi and (iii) relacorilant plus nab-paclitaxel to treat patients with endometrial cancer who had received one or two prior lines of therapy. Initial results are expected in late 2026."

P2 data • Platinum resistant • Platinum sensitive • Trial status • Endometrial Cancer • Ovarian Cancer

Corcept Submits Marketing Authorization Application to European Medicines Agency for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer (Businesswire) - "Corcept’s MAA submission is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials."

EMA filing • Platinum resistant • Ovarian Cancer

Corcept Presents ESMO 2025 Late-Breaker: Relacorilant Demonstrates Benefit in Patients with Platinum-Resistant Ovarian Cancer with Prior PARP Inhibitor Treatment (Businesswire) - "Relacorilant plus nab-paclitaxel showed a PFS benefit in patients with prior PARPi treatment (hazard ratio: 0.60; p-value: 0.0035) and in patients whose disease progressed while on a PARPi (hazard ratio: 0.56; p-value: 0.0046), with a median PFS of 7.36 months for both subgroups. Relacorilant plus nab-paclitaxel was well-tolerated in the PARPi subgroups, consistent with its known safety profile."

P3 data • Platinum resistant • Ovarian Cancer

Steroid receptors modulate oncogenic signaling and drive cell migration in pancreatic ductal adenocarcinoma Free (AACRPanCa 2025) - "Treatment with SR antagonists (mifepristone, relacorilant) attenuated cytokine- and serum-induced migration. Future studies will include invasion and sphere-forming assays, rigorous interrogation of stress-activated signaling pathways, SR-KRAS and SR-SR interactions, and transcriptional studies that define SR-dependent gene signatures in PDA. Our long term goal is to elucidate novel paths to improved PDA screening and treatment."

Breast Cancer • Hematological Malignancies • Hormone Receptor Breast Cancer • Leukemia • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer • IL1B • KRAS • PGR • TGFB1

Corcept to Present New Late-Breaking Data From Pivotal ROSELLA Trial of Relacorilant in Platinum-Resistant Ovarian Cancer at ESMO 2025 (Businesswire) - "The data, which will be presented in a late-breaking oral presentation on Sunday, October 19, 2025, focuses on trial participants who were previously treated with a PARP inhibitor, a patient population with particularly poor prognosis."

Late-breaking abstract • P3 data • Platinum resistant • Ovarian Cancer

The Effect of Glucocorticoid and Mineralocorticoid Receptor Antagonists in the Skin of Aged Female Mice. (PubMed, Int J Mol Sci) - "Mice were treated with selective GR (relacorilant), selective MR (eplerenone), or dual GR/MR (miricorilant) antagonists for 8 weeks. The results contrast with data from GR/MR knockout studies, highlighting the likely significance of receptor dynamics. Further studies of antagonist effects on receptor interactions with co-regulators appear warranted."

Journal • Preclinical • Dermatology • Inflammation • COL3A1

FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer (Businesswire) - "The FDA has assigned a PDUFA date of July 11, 2026 for the application....Corcept’s NDA is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials."

FDA filing • PDUFA • Platinum resistant • Ovarian Cancer

Effects of Relacorilant on Body Weight and Body Composition in Patients With Endogenous Hypercortisolism in the Phase 3 GRACE and GRADIENT Studies (ENDO 2025) - P3 | "These improvements may occur as early as after 6-10 weeks of treatment. Importantly, lean mass was preserved in both studies, in contrast to the reductions in lean mass reported with the most common classes of weight-loss agents."

Clinical • P3 data • Cushing’s Disease • Endocrine Disorders

Effects Of Relacorilant On Pituitary Tumor Volume In Patients With Cushing Disease: Results From The Phase 3 Grace Study (ENDO 2025) - P3 | "Previous case reports suggested that the pituitary tumor effects of relacorilant in patients with Cushing Disease (CD) are distinct from those of the FDA-approved GR antagonist mifepristone (Pivonello Front Endocrinol 2022)...In summary, pituitary tumor volume decreased or remained unchanged following treatment with relacorilant for the majority of patients with CD in the GRACE study. Relacorilant was also well-tolerated and led to significant improvements in HC-related signs and symptoms."

Clinical • Late-breaking abstract • P3 data • Cardiovascular • Cushing’s Disease • Diabetes • Endocrine Cancer • Hypertension • Oncology • Pituitary Gland Carcinoma • SSTR • SSTR2

Efficacy and Safety of Relacorilant in Individuals With Adrenal Hypercortisolism: Results From the Phase 3 GRACE and GRADIENT Studies (ENDO 2025) - P3 | "The safety profile in these studies was consistent with relacorilant's GR specificity and mechanism of action. There were no cases of adrenal insufficiency or vaginal bleeding associated with endometrial hypertrophy, and no cases of drug-induced hypokalemia or QT interval prolongation.In summary, relacorilant was well-tolerated and resulted in clinically and statistically significant treatment benefits in participants with adrenal hypercortisolism in the phase 3 GRACE and GRADIENT studies."

Clinical • P3 data • Cardiovascular • Diabetes • Endocrine Disorders • Hypertension • Nephrology • Renal Disease

Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update (Businesswire) - "Oncology:...Relacorilant to treat patients with platinum-resistant ovarian cancer - Submission of European Marketing Authorization Application (MAA) expected this quarter....'We expect that relacorilant can help treat earlier stages of ovarian cancer and other solid tumors and will soon initiate additional clinical trials'."

EMA filing • New trial • Platinum resistant • Ovarian Cancer

Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer (Businesswire) - "Corcept Therapeutics Incorporated...has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer...Corcept’s filing is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection."

FDA filing • Platinum resistant • Ovarian Cancer

Phase III results of relacorilant + nab-paclitaxel vs nab-paclitaxel in platinum-resistant ovarian cancer (PROC) (ROSELLA, GOG-3073, ENGOT-ov72): Secondary endpoints (ESMO-GC 2025) - P3 | "Key eligibility criteria included 1–3 prior lines of anticancer therapy and prior bevacizumab. Editorial acknowledgement Medical writing support was provided by Farida Khan, PhD, CMPP, an employee of Corcept Therapeutics Incorporated. Legal entity responsible for the study Corcept Therapeutics."

P3 data • Platinum resistant • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Tanshinone IIA improved psychological stress-induced embryo implantation disorders by inhibiting GC/GR signaling and promoting angiogenesis. (PubMed, Phytomedicine) - "Psychological stress disrupted embryo implantation by activating the GC/GR signaling. Tan IIA effectively alleviated stress-induced implantation disorders by inhibiting the GC/GR signaling. This study highlights the therapeutic potential of Tan IIA as a promising candidate for stress-related implantation disorders."

Journal • CNS Disorders • Metabolic Disorders • Psychiatry • CAT • CD31 • GPX4 • NR3C1 • PECAM1

Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. (PubMed, Lancet) - P3 | "The addition of relacorilant to nab-paclitaxel prolonged progression-free survival and interim results also showed an improvement in overall survival. Together, the results position the combination of relacorilant and nab-paclitaxel as a potential new standard treatment for patients with platinum-resistant ovarian cancer."

Journal • P3 data • Platinum resistant • Carcinosarcoma • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor