An Open-label, Global, Multi-Arm Study to Evaluate the Efficacy and Safety of Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (BELLA)

This is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments in patients with gynecological cancers.

Start Date11 Apr 2025

Sponsor / Collaborator

Corcept Therapeutics, Inc.

NCT05726292

/ RecruitingPhase 2IIT

A Randomized Phase II Trial of Neoadjuvant Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer

Researchers conducting this study hope to learn about the safety and effectiveness of combining two study drugs, relacorilant and enzalutamide, plus androgen deprivation therapy (ADT), also known as hormone therapy. This study is for individuals who have been diagnosed with advanced, high-risk prostate cancer and standard therapies available to treat your disease have not been effective. Participation in this research will last about 3 years and 9 months.

Start Date06 Jan 2025

Sponsor / Collaborator

The University of Chicago

NCT05257408

/ Active, not recruitingPhase 3

A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of Relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.

Start Date29 Jun 2022

Sponsor / Collaborator

Corcept Therapeutics, Inc.

[+1]

100 Clinical Results associated with Relacorilant

100 Translational Medicine associated with Relacorilant

100 Patents (Medical) associated with Relacorilant

Literatures (Medical) associated with Relacorilant

01 Oct 2025·Med

Targeting the glucocorticoid receptor as a therapeutic strategy for ovarian cancer: The ROSELLA study

Article

Author: Matulonis, Ursula A ; Lantsman, Taliya

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.

01 Aug 2025·PHYTOMEDICINE

Tanshinone IIA improved psychological stress-induced embryo implantation disorders by inhibiting GC/GR signaling and promoting angiogenesis

Article

Author: Fang, Qunying ; Zong, Lu ; Wang, Jiawei ; Han, Hui ; Zhao, Shiyu ; Shui, Lijun ; Chen, Shengyuan ; Li, Fangfang ; Meng, Ye ; Jin, Qi ; Wu, Limin ; Qiao, Zonghui

BACKGROUND:

The exact mechanism by which psychological stress leads to embryo implantation disorders remains unclear. Studies have shown that psychological stress is associated with elevated levels of glucocorticoids (GC). Successful embryo implantation is closely related to normal endometrial angiogenesis, a key process in the creation of a conducive environment for embryo implantation. Tanshinone IIA (Tan IIA), a compound derived from traditional Chinese medicine, promotes angiogenesis. This study aimed to elucidate how psychological stress impairs embryo implantation and explore the potential therapeutic effects of Tan IIA.

METHODS:

Female mice were randomly divided into seven groups: control, restraint stress, CORT125134 antagonizing glucocorticoid receptor (GR), 7.5, 15, 30 mg/kg Tan IIA, and aspirin. Open-field and elevated plus maze tests were employed to evaluate behavioral changes. The embryo implantation sites were quantified using trypan blue injection. Endometrial GC levels by ELISA, GR expression by RT-qPCR and WB, angiogenesis by HE and IHC, and angiogenic factors (VEGF, ANG2) by IF were measured. JC-1, ATP, p-DRP1^S616, and transmission electron microscopy were used to detect endometrial mitochondrial damage. Oxidative stress was determined through ROS, MDA, catalase, and GPX4 assays, and IF co-staining of CD31 with 4-HNE examined vascular oxidative injury. Endometrial receptivity was evaluated by LIF and integrin αvβ3 expression.

RESULTS:

Psychological stress significantly induced anxiety-like behavior, reduced implantation sites, impaired endometrial angiogenesis, triggered mitochondrial dysfunction and oxidative stress, and compromised endometrial receptivity via GC/GR signaling activation. Administration of Tan IIA effectively alleviated these stress-induced impairments in a dose-dependent manner, primarily by inhibiting GC/GR activation and GR nuclear translocation. Specifically, Tan IIA alleviated anxiety-like behavior, reduced the p-DRP1^S616/DRP1 ratio, restored MMP and ATP production, and attenuated mitochondrial vacuolization and crista disruption. In addition, Tan IIA markedly decreased the levels of ROS, MDA, and CAT, while enhancing the expression of GPX4, VEGF, ANG2, LIF, and integrin αvβ3.

CONCLUSION:

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.

01 Jun 2025·LANCET

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

Article

Author: Colombo, Nicoletta ; Diakos, Connie ; Artioli, Grazia ; McCollum, Michael E ; Hopp, Elizabeth ; Garbaos, Gabriel ; Van Gorp, Toon ; De La Cueva, Helena ; Mileshkin, Linda ; Oaknin, Ana ; Monk, Bradley J ; Scandurra, Giuseppa ; Balázs, Boglárka ; Salutari, Vanda ; Kang, Sokbom ; Leiser, Aliza L ; Scaranti, Mariana ; Pai, Sachin G ; Slomovitz, Brian ; Devaux, Alix ; Cassani, Chiara ; Gladieff, Laurence ; Lee, Yong Jae ; O'Malley, David M ; Bagaméri, Andrea ; Vergote, Ignace ; Kaczmarek, Emilie ; Bodnar, Lubomir ; Kesner-Hays, Amanda ; You, Benoit ; Caruso, Giuseppe ; Churruca, Cristina ; de Carvalho Calabrich, Aknar Freire ; Jubb, Adrian M ; Lorusso, Domenica ; Kim, Jae-Weon ; Nicum, Shibani ; McClung, Emily ; Clamp, Andrew ; Olawaiye, Alexander B ; Gilbert, Lucy ; Pashova, Hristina I ; Tudor, Iulia Cristina ; Kim, Byoung-Gie

BACKGROUND:

Relacorilant, a first-in-class selective glucocorticoid receptor antagonist, increases a tumour's sensitivity to chemotherapy by reducing cortisol signalling. This study aimed to show whether the addition of relacorilant to nab-paclitaxel improves progression-free and overall survival in females with platinum-resistant ovarian cancer.

METHODS:

This randomised, controlled, open-label phase 3 trial (ROSELLA [GOG-3073/ENGOT-ov72]) was done at 117 hospitals and community oncology treatment centres in 14 countries across Australia, Europe, Latin America, North America, and South Korea. Patients had to be aged 18 years or older and had to have a confirmed diagnosis of platinum-resistant, epithelial (ie, high-grade serous, endometrioid, or carcinosarcoma with a ≥30% epithelial component) ovarian, primary peritoneal, or fallopian tube cancer; up to three previous lines of anticancer therapy and previous bevacizumab and disease progression or intolerance to the most recent therapy; measurable disease according to the Response Evaluation Criteria in Solid Tumours (RECIST; version 1.1); an Eastern Cooperative Oncology Group performance status of 0 or 1; and adequate organ function. Patients were assigned (1:1) to relacorilant (150 mg orally the day before, of, and after nab-paclitaxel infusion) plus nab-paclitaxel (80 mg/m² intravenously on days 1, 8, and 15 of each 28-day cycle) or nab-paclitaxel monotherapy (100 mg/m² intravenously on the aforementioned schedule). The dual primary endpoints were progression-free survival assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumours (version 1.1) and overall survival, and were assessed in all randomly assigned patients by intention to treat. The safety population included all randomly assigned patients who received at least one dose of the assigned treatment. This trial was registered at ClinicalTrials.gov, NCT05257408, and is ongoing.

FINDINGS:

Between Jan 5, 2023, and April 8, 2024, 381 patients were randomly assigned to the combination group (n=188) or to the nab-paclitaxel monotherapy group (n=193). Patients receiving relacorilant plus nab-paclitaxel had a statistically significant improvement in progression-free survival assessed by blinded independent central review compared with those receiving nab-paclitaxel monotherapy (hazard ratio 0·70 [95% CI 0·54-0·91]; median 6·54 months [95% CI 5·55-7·43] vs 5·52 months [3·94-5·88]; stratified log-rank p=0·0076). At the planned interim analysis, there was a clinically meaningful difference in overall survival with the addition of relacorilant to nab-paclitaxel (0·69 [95% CI 0·52-0·92]; 15·97 months [95% CI 13·47-not reached] vs 11·50 months [10·02-13·57]; log-rank p=0·0121). Adverse events were similar across study groups when adjusted for nab-paclitaxel exposure; no new safety signals were observed.

INTERPRETATION:

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.

FUNDING:

Corcept Therapeutics.

News (Medical) associated with Relacorilant

19 Oct 2025

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Corcept Presents ESMO 2025 Late-Breaker: Relacorilant Demonstrates Benefit in Patients with Platinum-Resistant Ovarian Cancer with Prior PARP Inhibitor Treatment

New data from pivotal Phase 3 ROSELLA trial reinforce relacorilant plus nab-paclitaxel improves progression-free and overall survival in patients with platinum-resistant ovarian cancer, with no need for biomarker selection – including in people who progressed while on or after taking a PARP inhibitor, a patient population with particularly poor prognosis Corcept expands BELLA trial to three study arms: (i) platinum-resistant ovarian cancer, (ii) platinum-sensitive ovarian cancer and (iii) endometrial cancer REDWOOD CITY, Calif.--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today shared new late-breaking data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the European Society for Medical Oncology (ESMO) 2025 Annual Meeting. The data demonstrated a progression-free survival (PFS) benefit for patients who experienced disease progression while on or after taking a PARP inhibitor (PARPi), a patient population with particularly poor prognosis. The presentation slides can be found here. The company also announced expansion of the Phase 2 BELLA trial in a poster session at ESMO, found here. New relacorilant data presented at ESMO demonstrated a consistent benefit in PARPi subgroups to overcome chemotherapy resistance. 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. Importantly, the type, frequency and severity of adverse events in the combination arms were comparable to those in the nab-paclitaxel monotherapy arms. Relacorilant conferred its benefit without increasing the safety burden of the patients who received it. “These new ROSELLA data substantiate the significant benefit of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer, an extremely difficult-to-treat cancer,” said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas University, Rozzano, European Network of Gynaecological Oncological Trial groups Principal Investigator in the ROSELLA trial and ESMO presenter. “These findings are especially promising for patients with an exceptionally poor prognosis and necessitate further research of relacorilant and its potential benefit in earlier treatment lines of gynecological cancers.” Corcept also announced the expansion of the recently initiated Phase 2 BELLA trial 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. “The ROSELLA data give us confidence to expand the BELLA trial to include patients with ovarian cancer whose disease is platinum sensitive (an earlier stage of tumor progression), as well as patients with endometrial cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “With the FDA's recent acceptance of our New Drug Application for relacorilant in platinum-resistant ovarian cancer and the expansion of our BELLA trial, we are closer than ever to bringing new and vital treatment to patients in need. We are grateful to all the patients and investigators for participating in our ongoing trials.” Corcept previously announced that ROSELLA met its primary endpoint of improved PFS, with no need for biomarker selection. Patients who received relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in the risk of disease progression compared to patients who received nab-paclitaxel monotherapy (hazard ratio: 0.70; p-value: 0.0076). 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 (hazard ratio: 0.69; p-value: 0.0121). The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG). About Relacorilant Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism, and a PDUFA date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. Corcept also recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer. About Cortisol’s Role in Oncology Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer. About Ovarian Cancer Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns six months after receiving platinum-containing therapy have “platinum-sensitive” disease and those with disease progression of less than six months have “platinum-resistant” disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease and 13,000 women with platinum-sensitive disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com. Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC’s website. In this press release, forward-looking statements include statements concerning the potential of relacorilant combined with nab-paclitaxel to benefit patients, including its potential benefit in earlier treatment lines of gynecological cancers, the expectation of initial results from the Phase 2 BELLA trial, including the expansion thereof and expected timing of initial results, and Corcept’s ability to bring new and vital treatment to patients. We disclaim any intention or duty to update forward-looking statements made in this press release.

Clinical ResultPhase 2Orphan DrugPhase 3Drug Approval

18 Oct 2025

·www.prnewswire.com

Florida Cancer Specialists & Research Institute Shaping the Future of Cancer Care at Global Congress

Oral Presentation to be Featured on Initial Results of a First-in-Human Study for a Promising Targeted Therapy for Advanced/Metastatic Solid Tumors. ESMO 2025 abstracts featuring FCS research: 965P, 967P, 981P, 1014eP, 1031eTiP, 1068P, 1070P, 1073P, 1073P, 1113P, 1153P, 1166P, 1172P, 1196P, 1221TiP, 1239eTiP, 1349P, 158P, 2604P FORT MYERS, Fla., Oct. 18, 2025 /PRNewswire/ -- Breakthrough clinical research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) will be in the spotlight this week in Berlin at the European Society of Medical Oncology (ESMO) Congress 2025. Among the 23 studies co-authored by FCS physician investigators selected for presentation to oncology experts worldwide, one has earned the distinction of being featured as an oral presentation and four as poster presentations by FCS first authors. Continue Reading 23 Florida Cancer Specialists & Research Institute abstracts are being presented at the European Society of Medical Oncology Congress 2025 in Berlin, Germany including one oral presentation by FCS Director of Drug Development Manish R. Patel, MD, and four additional poster presentations by FCS first-authors. "FCS is engaged in significant and transformative scientific discoveries that are driving new possibilities and better outcomes for patients everywhere," said Lucio N. Gordan, MD, FCS president & managing physician. The following physician leader is first author of an oral presentation at the ESMO Congress: Manish R. Patel, MD, FCS director of drug development, will participate in an oral presentation followed by expert discussion and perspectives of initial results of a first-in human study: A tumor-associated Mucin 1 (TA-MUC1)–directed Antibody–drug Conjugate (ADC), in Patients (pts) with Advanced/Metastatic (adv/met) Solid Tumors. The following physician leaders are first authors of poster presentations at the ESMO Congress: Bradley Monk, MD, FCS medical director of late-phase clinical research, will present the following abstracts: Post hoc survival outcomes based on initial and subsequent treatment in patients (pts) with mismatch repair proficient/microsatellite stable (MMRp/MSS) primary advanced or recurrent endometrial cancer (pA/R EC) in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial. Tisotumab Vedotin Plus Carboplatin or Pembrolizumab in Recurrent or Metastatic Cervical Cancer: 5-Year Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study. Cesar Augusto Perez, MD, FCS, director of drug development, Sarah Cannon Research Institute (SCRI) at FCS, will review and discuss in a poster presentation, Phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumours. Judy S. Wang, MD, FCS associate director of drug development will present and discuss the findings of the following abstract: Histological biomarker analysis of nonclinical and baseline tumor samples from the phase 1 dose escalation study assessing micvotabart peliodotin (MICVO) in advanced solid tumors. Dr. Patel, who oversees early phase research at FCS' three drug development units, said, "Our team is proud to be at the forefront of oncology research, leading first-in-human studies and advancing cutting-edge targeted therapies." Dr. Monk leads initiatives to expand and deploy late-phase clinical trials. He noted, "By pushing the boundaries of what's possible, we're helping bring the next generation of treatments to patients who need them most and are dedicated to increasing clinical trial accessibility to patients worldwide." FCS researchers have also co-authored numerous abstracts that will also be featured in poster presentations throughout the annual international symposium: Barry Berman, MD, MS: Clinical and biomarker results from E7386 study 102: Global dose-expansion cohort of E7386 + envatinib in patients with advanced/recurrent endometrial cancer that progressed on platinum-based chemotherapy and an anti−PD-(L)1 immunotherapy Bradley Monk, MD: Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. (Simultaneous publication in the Annals of Oncology.) Human papillomavirus integration site mapping in advanced cervical cancer: The NRG Oncology/GOG-0240 NIH Cancer Moonshot. Second progression-free survival (PFS2) and subsequent treatment in patients (pts) with folate receptor alpha (FR⍺)-positive platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator's choice chemotherapy (ICC): Phase III MIRASOL trial. 5-year progression-free survival (PFS) with rucaparib (RUCA) maintenance in patients with newly diagnosed advanced ovarian cancer in ATHENA-MONO (GOG-3020/ENGOT-ov45). (Simultaneous publication in the Annals of Oncology.) The relationship between patient-reported outcomes and clinician-rated toxicity in participants with locally advanced cervix cancer in the OUTBACK trial. GOG-3119/ENGOT-en29/TroFuse-033: A Phase 3, Randomized Study of Sacituzumab Tirumotecan Plus Pembrolizumab vs Pembrolizumab Alone as First-Line Maintenance Therapy for Mismatch Repair-Proficient Endometrial Cancer. BELLA: A Phase 2 Study of Relacorilant Plus Nab-Paclitaxel +/- Bevacizumab in Patients with Gynecologic Cancers. Manish R. Patel, MD: A phase 1 study of the next-generation farnesyltransferase inhibitor (FTI) KO-2806 as monotherapy in advanced solid tumors. COM701 in ovarian cancer: A pooled analysis of 3 phase I clinical trials. Farnesyltransferase inhibitor (FTI) KO-2806 in combination with cabozantinib (cabo) in renal cell carcinoma (RCC): Preliminary results from FIT-001 Phase 1 trial. Single-agent divarasib experience in patients with KRAS G12C-positive pancreatic adenocarcinoma (panc), cholangiocarcinoma (cholangio), and other solid tumors. Cesar Augusto Perez, MD: Tipifarnib (TIP) and alpelisib (ALP) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Phase 1 results from KURRENT-HN. Phase 1 global study of Iza-Bren (BL-B01D1), an EGFR × HER3 bispecific antibody–drug conjugate (ADC), in patients with metastatic or unresectable NSCLC and other solid tumours. Judy S. Wang, MD: First- in- Human Study of the First-in-class Non-cellular Targeting Antibody-Drug Conjugate (ADC), MICVO, in Patients with Select Solid Tumors. Phase 1 Expansion Study of the First-in-class Non-cellular Targeting Antibody-Drug Conjugate (ADC), Micvotabart Pelidotin (MICVO), in Patients with Select Advanced Solid Tumors. FCS provides access to advanced clinical trial options across 29 locations in Florida, bringing promising therapies closer to home for cancer patients. Over 110 new early-phase and 40 late-phase studies are launched annually. FCS has played a vital role in the development of numerous cancer drugs approved by the U.S. Food and Drug Administration (FDA). A longstanding partnership with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, provides patients with access to a comprehensive listing of clinical trials available in the U.S. Additionally, a partnership with Paradigm Health, Inc. helps streamline and accelerate matching patients to available clinical trials. Representing more than 45,000 members globally, ESMO is a reference for oncology education and information. The ESMO Congress is a globally influential oncology platform for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. All of the accepted abstracts will be published online at ESMO. About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. In fact, before receiving FDA approval, the majority of new cancer drugs in the U.S. were first made available to patients through participation in clinical trials at FCS. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. SOURCE Florida Cancer Specialists & Research Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultASCOImmunotherapyPhase 3

14 Oct 2025

·www.businesswire.com

Corcept Submits Marketing Authorization Application to European Medicines Agency for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer. Corcept’s MAA submission 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. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arms were comparable to those in the nab-paclitaxel monotherapy arms. Relacorilant conferred its benefit without increasing the safety burden of the patients who received it. The U.S. Food and Drug Administration (FDA) is reviewing Corcept’s application to market relacorilant in the United States to treat patients with platinum-resistant ovarian cancer. The FDA’s Prescription Drug User Fee Act (PDUFA) target action date is July 11, 2026. “Our MAA submission brings us a step closer to our goal of delivering relacorilant to patients with platinum-resistant ovarian cancer,” said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. “Better treatment options are urgently needed. Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated.” About Relacorilant Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism, and a PDUFA date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. About Cortisol’s Role in Oncology Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer. About Platinum-Resistant Ovarian Cancer Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have “platinum-resistant” disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com. Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC’s website. In this press release, forward-looking statements include statements concerning: relacorilant’s potential to receive regulatory approval either as a treatment for patients with platinum-resistant ovarian cancer, or as a treatment for patients with hypercortisolism; the anticipated timing of FDA review of relacorilant as a treatment for patients with hypercortisolism and for patients with platinum-resistant ovarian cancer; Corcept’s intent to deliver relacorilant to patients with platinum-resistant ovarian cancer; relacorilant’s potential to redefine how platinum-resistant ovarian cancer is treated; and Corcept’s ability to develop relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. We disclaim any intention or duty to update forward-looking statements made in this press release.

Clinical ResultOrphan DrugDrug ApprovalPhase 3NDA

100 Deals associated with Relacorilant

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KEGG	Wiki	ATC	Drug Bank
D11336	Relacorilant	-	DB14976

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Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Resistant Ovarian Carcinoma	NDA/BLA	United States	Corcept Therapeutics, Inc.	14 Jul 2025
Cushing Syndrome	NDA/BLA	United States	Corcept Therapeutics, Inc.	30 Dec 2024
Peritoneal Neoplasms	Phase 3	United States	Corcept Therapeutics, Inc.	29 Jun 2022
Peritoneal Neoplasms	Phase 3	Argentina	Corcept Therapeutics, Inc.	29 Jun 2022
Peritoneal Neoplasms	Phase 3	Australia	Corcept Therapeutics, Inc.	29 Jun 2022
Peritoneal Neoplasms	Phase 3	Belgium	Corcept Therapeutics, Inc.	29 Jun 2022
Peritoneal Neoplasms	Phase 3	Brazil	Corcept Therapeutics, Inc.	29 Jun 2022
Peritoneal Neoplasms	Phase 3	Canada	Corcept Therapeutics, Inc.	29 Jun 2022
Peritoneal Neoplasms	Phase 3	France	Corcept Therapeutics, Inc.	29 Jun 2022
Peritoneal Neoplasms	Phase 3	Hungary	Corcept Therapeutics, Inc.	29 Jun 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04308590 (GRADIENT, CTgov)	Phase 3	Cushing Syndrome \| Adrenocortical Adenoma	137	Placebo+Relacorilant (Relacorilant)	siuccwukdr(vvncrjnzvu) = bbmvbeyibh cgnzqnrorh (djchsehnee, eutrieetwz - njumzaaoet) View more	-	03 Aug 2025
				Placebo (Placebo)	siuccwukdr(vvncrjnzvu) = pbxrwesswn cgnzqnrorh (djchsehnee, blisiphhrs - smyscwtpfs) View more
NCT05257408 (ROSELLA \| GOG-3073 \| ENGOT-ov72, ESMO_GCC2025)	Phase 3	Platinum-Resistant Ovarian Carcinoma	381	Relacorilant + nab-paclitaxel	yjdyylncrs(xftzdbgxzk) = hipbmpiclw xzglcrhhvb (bunkvzwmxc ) View more	Positive	19 Jun 2025
				nab-paclitaxel	yjdyylncrs(xftzdbgxzk) = vxhuhrdiwy xzglcrhhvb (bunkvzwmxc ) View more
NCT03776812 (CTgov)	Phase 2	Recurrent Platinum-Resistant Primary Peritoneal Carcinoma \| Recurrent ovarian cancer \| Recurrent Primary Peritoneal Carcinoma ... View more	178	Nab-paclitaxel+Relacorilant (Arm A: Continuous Relacorilant Dosing)	jqzxfhjwii(frkcpovnxm) = femjwnrfip cbubeaobmv (esrkmujvqp, cyhpacthbb - ahfoxrrwvy) View more	-	30 Apr 2025
				Nab-paclitaxel+Relacorilant (Arm B: Intermittent Relacorilant Dosing)	jqzxfhjwii(frkcpovnxm) = vqkrnxalri cbubeaobmv (esrkmujvqp, mgeyylhquu - skwngghwsy) View more
NCT03697109 (GRACE, CTgov)	Phase 3	Endogenous Cushing Syndrome	152	Relacorilant (Relacorilant (RW Phase))	fozpzhuhyj = czhwajzlps vqhcotzydx (gxleqphiuk, jvpzidiuzj - ggcjmlcknp) View more	-	24 Apr 2025
				Placebo (Placebo (RW Phase))	fozpzhuhyj = sqajtrtgse vqhcotzydx (gxleqphiuk, yeierwudbe - vjclgpnngo) View more
NCT05257408 (ROSELLA, Company_Website \| NEWS) Manual	Phase 3	Platinum-Resistant Ovarian Carcinoma	381	Relacorilant + nab-paclitaxel	zpibvrgkce(etrxrvxcpu) = ybzrrmyylr hdxuwxbowe (bfjgbphklo, 5.55 - 7.43) Met View more	Positive	31 Mar 2025
				Nab-paclitaxel	zpibvrgkce(etrxrvxcpu) = tkeqcpgswo hdxuwxbowe (bfjgbphklo, 3.94 - 5.88) Met View more
NCT03604198 (BusinessWire) Manual	Phase 3	Cushing Syndrome	116	Relacorilant	roewdcvhbj(opvlliiyrg) = At month 24 of the study, patients exhibited clinically meaningful and statistically significant reductions in mean systolic blood pressure (10.0 mm Hg; p-value: 0.012) and mean diastolic blood pressure (7.3 mm Hg; p-value: 0.016), compared to their measurement at entry into the long-term extension study. ihlcbtbuld (ocdrbmmxib ) View more	Positive	16 Dec 2024
NCT03604198 (Company_Website) Manual	Phase 2	Cushing Syndrome	53	Relacorilant	qonelmkyeu(jgnpozzcip) = otyrgioktd nblqrkkpke (yivwccopol ) View more	Positive	25 Nov 2024
NCT04308590 (GRADIENT, Biospace) Manual	Phase 3	Cushing Syndrome	137	relacorilant	ltcbehvvlh(nzblvykrhp) = lkkcmqnpqz boxvynhtdv (wrswcrhpnq ) Met	Positive	30 Oct 2024
				Placebo	ltcbehvvlh(nzblvykrhp) = zpfpkrgcmb boxvynhtdv (wrswcrhpnq ) Met
NCT02804750 \| NCT00280475 (Pubmed \| J Endocrinol Invest)	Phase 2	Cushing Syndrome factor VIII \| activated partial thromboplastin time \| platelet count ... View more	34	Relacorilant (Surgery)	wgodmytpbu(yjulmnfakv) = oudvoqleyq gayvznsmzb (qmuyujeuzv )	Positive	21 Sep 2024
NCT03697109 (GRACE, ENDO2024)	Phase 3	Cushing Syndrome	152	Relacorilant 100 mg QD	kmscidgnpk(ensrikriej) = qjnlzgckmr nocehkbyqm (mrdsvyguix, 6.7) View more	Positive	01 Jun 2024

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