relacorilant (CORT125134) / Corcept Therap - LARVOL DELTA

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

BELLA: A Phase 2 Study of Relacorilant Plus Nab-Paclitaxel and Bevacizumab in Patients with Platinum-Resistant Ovarian Cancer (ESMO 2025) - No abstract available

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

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

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

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 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

ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). (ASCO 2025) - P3 | "Key eligibility criteria included 1–3 prior lines of anticancer therapy and prior bevacizumab. Relacorilant + nab-paclitaxel is the first treatment regimen to demonstrate a PFS and OS benefit in patients with PROC compared to a weekly taxane, the most efficacious comparator. These positive efficacy data and a favorable safety profile position relacorilant + nab-paclitaxel as a new standard for patients with PROC, without the need for biomarker selection."

Clinical • Combination therapy • Late-breaking abstract • Monotherapy • P3 data • Platinum resistant • Anemia • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor

Corcept Presents Pivotal Clinical Data in ASCO Late-Breaker with Simultaneous Publication in The Lancet: Relacorilant Improves Progression-Free and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer (Corcept Therapeutics Press Release) - P3 | N=381 | ROSELLA (NCT05257408) | Sponsor: Corcept Therapeutics | "ROSELLA met its primary endpoint of improved progression-free survival as assessed by blinded independent central review (PFS-BICR). Patients who received relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients who received nab-paclitaxel monotherapy (hazard ratio: 0.70; p-value: 0.0076). Median PFS-BICR was extended to 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. In addition, PFS assessed by investigators was consistent with PFS-BICR, with a hazard ratio of 0.71 (p-value: 0.0030). An interim analysis of overall survival (OS), showed that the addition of relacorilant reduced the risk of death by 31 percent, substantially lengthening patients’ lives."

P3 data • Platinum resistant • Ovarian Cancer

Relacorilant in Combination With Nab-paclitaxel and Bevacizumab in Advanced, Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Corcept Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

Is adrenalectomy still required as a treatment in Cushing disease? (ESPE-ESE 2025) - "In March 2020, the tumor relapse required Pasireotide 1.8 mg/day and cabergoline 1.5 mg/week increased at 8 mg/week with no biochemical or morphological response...Due to local and systemic progression of the disease, she started Temozolomide with in 2022 with no results. Since 2022 she was enrolled on Relacorilant in GRACE clinical trial (CORT125134-455) with clinical response, until June 2024. Afterwards she was treated with Metyrapone 750 mg/day, followed by Ketoconazole 800mg/day without significant improvement...Nevertheless, after the adrenalectomy, there was a noticeable improvement in biological markers. The surgery continues to represent a vital stage in the treatment journey."

Cardiovascular • Cushing’s Disease • Dermatology • Diabetes • Dyslipidemia • Growth Hormone Deficiency • Hypertension • Metabolic Disorders • Oncology • Osteoporosis • Rheumatology

Medical Treatment of Hypercortisolism with Relacorilant: Final Results of the Phase 3 GRACE Study (ESPE-ESE 2025) - P3 | "Significant and sustained improvements in hypertension, hyperglycemia, and other manifestations of cortisol excess were observed during relacorilant treatment. Treatment with relacorilant was well tolerated in both the OL and RW phases of GRACE."

Clinical • P3 data • Back Pain • Cardiovascular • CNS Disorders • Diabetes • Endocrine Disorders • Hypertension • Insomnia • Metabolic Disorders • Musculoskeletal Pain • Nephrology • Pain • Renal Disease • Sleep Disorder

Relacorilant Improved Blood Pressure and Maintained Other Cardiometabolic Improvements in Long-term Study in Patients With Endogenous Hypercortisolism (Cushing Syndrome) (ESPE-ESE 2025) - P2, P3 | "No new safety signals were identified during up to 6 years of treatment. Long-term treatment with relacorilant led to significant and durable cardiometabolic improvements in patients with hypercortisolism and was well-tolerated."

Clinical • Cushing’s Disease • Endocrine Disorders

CORCEPT THERAPEUTICS ANNOUNCES FIRST QUARTER FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE (Businesswire) - "Clinical Development:...Hypercortisolism (Cushing’s Syndrome) - (i) GRACE - Pivotal Phase 3 trial of relacorilant in 152 patients with all etiologies of hypercortisolism - Results presented at Endocrine Society (ENDO) annual meeting and Heart in Diabetes (HiD) conference in June 2024; (ii) GRADIENT - Randomized, double-blind, placebo-controlled, Phase 3 trial of relacorilant in 137 patients with hypercortisolism caused by adrenal gland pathology – Results will be presented at American Association of Clinical Endocrinology (AACE) annual meeting in May 2025...; (iii) CATALYST Part 2 - Randomized, double-blind, placebo-controlled study of Korlym in 136 patients with hypercortisolism - Results to be presented at the American Diabetes Association’s 85th Scientific Sessions (ADA) in June 2025; (iv) MOMENTUM - Enrollment continues in 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension - Results expected by year-end."

Clinical data • Cushing’s Disease

CORCEPT THERAPEUTICS ANNOUNCES FIRST QUARTER FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE (Businesswire) - "Clinical Development:...Oncology - Relacorilant for patients with platinum-resistant ovarian cancer - NDA submission expected in the third quarter with submission of Marketing Authorization Application (MAA) in Europe shortly thereafter."

EMA filing • FDA filing • Platinum resistant • Ovarian Cancer

Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2 | N=178 | Completed | Sponsor: Corcept Therapeutics | Active, not recruiting ➔ Completed

Platinum resistant • Trial completion • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • MUC16

CORCEPT TO PRESENT LATE-BREAKING DATA FROM PIVOTAL PHASE 3 ROSELLA TRIAL OF RELACORILANT IN PLATINUM-RESISTANT OVARIAN CANCER AT ASCO 2025 (Businesswire) - "Corcept Therapeutics Incorporated...will present data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The data will be presented in a late-breaking oral presentation on Monday, June 2, 2025."

P3 data • Platinum resistant • Ovarian Cancer

Corcept Initiates Trial of Relacorilant Plus Nab-Paclitaxel and Bevacizumab in Patients With Platinum-Resistant Ovarian Cancer (Businesswire) - "Corcept Therapeutics Incorporated...announced the start of BELLA, a Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab evaluating efficacy and safety in patients with platinum-resistant ovarian cancer. BELLA is a single-arm, open-label trial with a planned enrollment of 90 women with recurrent, platinum-resistant ovarian cancer at approximately 50 sites in North America, Europe and Asia-Pacific. Patients will receive relacorilant in combination with nab-paclitaxel and bevacizumab."

Platinum resistant • Trial status • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

Relacorilant in Combination With Nab-paclitaxel and Bevacizumab in Advanced, Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Corcept Therapeutics

New P2 trial • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

Corcept Therapeutics shares surge on positive late-stage ovarian cancer trial results (Proactiveinvestors) - "Corcept Therapeutics...shares surged more than 85% after the company announced positive results from its Phase 3 ROSELLA trial, evaluating relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer, that will support regulatory applications in the US and Europe. The trial met its primary endpoint, demonstrating a 30% reduction in the risk of disease progression compared to nab-paclitaxel alone."

P3 data • Platinum resistant • Stock price • Ovarian Cancer

Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer (Businesswire) - P3 | N=381 | ROSELLA (NCT05257408) | Sponsor: Corcept Therapeutics | "Results will support a New Drug Application (NDA) in the United States and a Marketing Authorization Application (MAA) in Europe....In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). Their median PFS-BICR was 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. At an interim evaluation of overall survival (OS), patients treated with relacorilant plus nab-paclitaxel had a significant improvement in OS, with a median OS of 16.0 months, compared to 11.5 months for patients receiving nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.012). Relacorilant was well-tolerated and no new safety signals were observed."

P3 data • Platinum resistant • Ovarian Cancer

Relacorilant plus nab-paclitaxel for recurrent, platinum-resistant ovarian cancer: a cost-effectiveness study. (PubMed, J Gynecol Oncol) - P2 | "From a US health care system perspective, IN may be cost-effective compared to CN for patients with recurrent platinum-resistant ovarian cancer, and IN is also better than CN and N in terms of efficacy. Therefore, IN is a high-quality regimen for clinicians to treat patients with recurrent platinum-resistant ovarian cancer."

HEOR • Journal • Oncology • Ovarian Cancer • Solid Tumor

ROSELLA: Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (clinicaltrials.gov) - P3 | N=381 | Active, not recruiting | Sponsor: Corcept Therapeutics | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2024 ➔ Mar 2026

Monotherapy • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor