A Phase 2 Study of Relacorilant in Combination With Nab-paclitaxel and Bevacizumab in Advanced, Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (BELLA)

This is a Phase 2, single-arm, open-label study to evaluate efficacy and safety of intermittent dosing of relacorilant in combination with nab-paclitaxel and bevacizumab in patients with ovarian cancer.

开始日期2025-04-11

申办/合作机构

Corcept Therapeutics, Inc.

NCT05726292

/ Recruiting临床2期IIT

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.

开始日期2025-01-06

申办/合作机构

The University of Chicago

NCT05257408

/ Active, not recruiting临床3期

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.

开始日期2022-06-29

申办/合作机构

Corcept Therapeutics, Inc.

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100 项与 Relacorilant 相关的临床结果

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100 项与 Relacorilant 相关的转化医学

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100 项与 Relacorilant 相关的专利（医药）

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项与 Relacorilant 相关的文献（医药）

2024-11-04·ONCOLOGIST

Relacorilant plus nab-paclitaxel for the treatment of metastatic pancreatic ductal adenocarcinoma: results from the open-label RELIANT study

Article

作者: Leal, Alexis D ; Skeel, Roland T ; Fountzilas, Christos ; Pashova, Hristina ; Mann, Grace ; Oberstein, Paul E ; Alese, Olatunji B ; Huyck, Timothy K ; Noonan, Anne M ; Kio, Ebenezer A ; Chiorean, Elena Gabriela ; Bahary, Nathan ; Borazanci, Erkut H ; Lee, Valerie ; Chung, Vincent ; Philip, Philip A ; Wainberg, Zev A ; Hanna, Wahid T ; Cardin, Dana B

Abstract:

Background:

Modulation of glucocorticoid receptor (GR) activity in tumor cells enhances chemotherapy efficacy. We evaluated the selective GR modulator relacorilant plus nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who had received at least 2 prior therapy lines.

Patients and Methods:

In this open-label, single-arm, phase III study, patients received once-daily oral relacorilant (100 mg, titrated to 150 mg in 25 mg increments/cycle) and nab-paclitaxel (80 mg/m2) on days 1, 8, and 15 of 28-day cycles. The primary efficacy endpoint was objective response rate (ORR) by blinded independent central review. Progression-free survival (PFS), overall survival (OS), target gene modulation, and safety were also assessed.

Results:

Of 43 patients enrolled, 31 were evaluable for ORR (12 did not reach first postbaseline radiographic assessment). An interim analysis to assess whether ORR was ≥10% showed no confirmed responses and the study was discontinued. Two (6.5%) patients attained unconfirmed partial responses and 15 (48.4%) had stable disease. Fourteen of 31 (45.2%) patients had reductions in target lesion size, despite prior nab-paclitaxel exposure in 12 of the 14. Median PFS and OS were 2.4 months (95% CI, 1.4-4.2) and 3.9 months (95% CI, 2.8-4.9), respectively. The most common adverse events were fatigue and nausea. RNA analysis confirmed that relacorilant plus nab-paclitaxel suppressed 8 cortisol target genes of interest.

Conclusion:

Relacorilant plus nab-paclitaxel showed modest antitumor activity in heavily pretreated patients with mPDAC, with no new safety signals. Studies of this combination in other indications with a high unmet medical need are ongoing.

2024-08-02·Expert Review of Anticancer Therapy

Relacorilant in recurrent ovarian cancer: clinical evidence and future perspectives

Review

作者: Marchetti, Claudia ; Ghizzoni, Viola ; Salutari, Vanda ; Scambia, Giovanni ; Vertechy, Laura ; Giudice, Elena ; Fagotti, Anna ; Sassu, Carolina Maria ; Carbone, Maria Vittoria

INTRODUCTION:

Relacorilant (CORT125134, Corcept Therapeutics) is a selective glucocorticoid receptor modulator, which reverses the glucocorticoid-mediated anti-apoptotic effects and restores the taxane chemosensitivity in epithelial ovarian cancer cells. Given those preclinical findings, relacorilant is currently under investigation in clinical trials in combination with nab-paclitaxel for the platinum-resistant ovarian cancer setting.

AREAS COVERED:

Already published preclinical and clinical evidence of relacorilant antitumor activity was analyzed and discussed. Ongoing clinical trials registered on clincaltrials.gov were also reported. The review aimed to summarize the status of relacorilant, the mechanism of action, the published and ongoing trials, and its safety and efficacy.

EXPERT OPINION:

Relacorilant combined with nab-paclitaxel, may represent a promising strategy for the treatment of platinum-resistant ovarian cancer patients. After preliminary positive results in terms of clinical efficacy, a randomized phase III trial is ongoing to confirm the findings from the published phase II study.

2024-06-03·Clinical cancer research : an official journal of the American Association for Cancer Research

A Phase I Trial of Enzalutamide Plus Selective Glucocorticoid Receptor Modulator Relacorilant in Patients with Metastatic Castration-Resistant Prostate Cancer

Article

作者: O'Donnell, Peter H. ; Szmulewitz, Russell Z. ; Serritella, Anthony V. ; Stadler, Walter M. ; Sweis, Randy F. ; Desai, Kunal B.

Abstract:

Purpose::

The majority of patients with metastatic prostate cancer who receive androgen-deprivation therapy and androgen receptor (AR) signaling inhibitors (ARSI) progress. Activation of the glucocorticoid receptor (GR) is associated with ARSI resistance. This single-arm phase I trial assessed safety and pharmacokinetic (PK) feasibility of a combined AR antagonist (enzalutamide) and selective GR modulator (relacorilant) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Patients and Methods::

This was a phase I trial (NCT03674814) of relacorilant and enzalutamide in patients with refractory mCRPC enrolled using a 6+3 design. The enzalutamide dose was kept constant at 120 mg/d with escalating doses of relacorilant based on safety and PK measures in cohorts of ≥6 patients. The primary objective was safety and establishment of pharmacologically active doses. Secondary objectives were related to antitumor activity.

Results::

Thirty-five patients with mCRPC were enrolled. Twenty-three were accrued across three dose cohorts in the dose-escalation phase, and 12 enrolled at the recommended phase II dose. The combination was generally well tolerated, safe, and achieved desirable enzalutamide PK. RP2D of 120 + 150 mg/d, respectively, was established. Median time on study was 2.2 months with four patients remaining on study for longer than 11 months. Four of 12 evaluable patients had a prostate-specific antigen (PSA) partial response.

Conclusions::

This is the first prospective trial combining an AR antagonist and a nonsteroidal selective GR modulator. The combination was safe and well tolerated with PSA response and prolonged disease control observed in a limited subset of patients. Further prospective trials are justified to evaluate efficacy and identify predictive biomarkers of response.

项与 Relacorilant 相关的新闻（医药）

2025-05-15

·PRNewswire

Cushing's Disease Market Poised for Significant Growth Across the 7MM During the Study Period (2020-2034) with Rising Awareness and Diagnostic Improvements | DelveInsight

The Cushing's disease pipeline possesses some drugs in mid and late-stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including relacorilant, clofutriben, atumelnant, and others. The expected launch of these therapies shall further create a positive impact on the Cushing's disease market. LAS VEGAS, May 15, 2025 /PRNewswire/ -- DelveInsight's Cushing's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Cushing's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Cushing's Disease Market Report According to DelveInsight's analysis, the market size for Cushing's disease was found to be USD 1 billion in the 7MM in 2024. In 2024, among all the current therapies for Cushing's disease, the highest revenue was generated by Mifepristone (KORLYM and generics) in the US. Based on DelveInsight's assessment in 2024, the 7MM had approximately 37K diagnosed prevalent cases of Cushing's disease. These cases are expected to rise due to advancements in diagnostic capabilities and increased awareness about the disease during the forecast period (2025–2034). Leading Cushing's disease companies developing emerging therapies, such as Corcept Therapeutics, Sparrow Pharmaceuticals, Crinetics Pharmaceuticals, H. Lundbeck, Stero Therapeutics, and others, are developing novel Cushing's disease drugs that can be available in the Cushing's disease market in the coming years. The promising Cushing's disease therapies in the pipeline include DUPIXENT (dupilumab), Linerixibat (GSK2330672), NEMLUVIO/MITCHGA (nemolizumab), Volixibat, and others. In March 2025, Corcept Therapeutics announced that the FDA had assigned a PDUFA target action date of December 30, 2025, for relacorilant to treat patients with endogenous hypercortisolism. In February 2025, Crinetics Pharmaceuticals mentioned that the company anticipates beginning enrollment for Atumelnant (CRN04894) in Phase Ib/IIa trials for Cushing's disease in late 2025 or early 2026. In October 2024, Sparrow Pharmaceuticals announced that clofutriben had been granted Orphan Drug Designation (ODD) by the US FDA for the treatment of endogenous Cushing's syndrome. Discover which therapies are expected to grab the major Cushing's disease market share @ Cushing's Disease Market Report Cushing's Disease Overview Cushing's disease is a rare but serious endocrine disorder caused by a pituitary tumor that triggers excessive cortisol production. It presents with a variety of symptoms such as weight gain, fatigue, mood disturbances, high blood pressure, and impaired glucose tolerance. Cushing's syndrome is responsible for 80–85% of hypercortisolism cases, with 75–80% of those linked to ACTH-producing pituitary adenomas. Without treatment, the 5-year survival rate is only about 50%, emphasizing the urgent need for effective therapies. Diagnosing Cushing's disease is especially difficult because it is rare, shares symptoms with other disorders, and presents in various ways. Only 40–60% of patients have a detectable tumor on standard Magnetic Resonance Imaging (MRI), and the diagnosis is often delayed by an average of 7 years. Cushing's Disease Epidemiology Segmentation The Cushing's disease epidemiology section provides insights into the historical and current Cushing's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Cushing's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Cushing's Disease Total Diagnosed Prevalent Cases of Cushing's Disease Gender-Specific Diagnosed Prevalent Cases of Cushing's Disease Age-Specific Diagnosed Prevalent Cases of Cushing's Disease Cushing's Disease Treatment Market The primary treatment for Cushing's disease is usually transsphenoidal surgery to remove the pituitary tumor, which often leads to remission. However, some patients may experience a recurrence. When surgery is unsuccessful or not an option, medical therapies are used to control cortisol levels. Various medications are available for managing Cushing's disease, especially in cases where surgery is ineffective or not feasible. One such drug is KORLYM, developed by Corcept Therapeutics, approved for treating hyperglycemia in patients with Cushing's syndrome who also have Type 2 diabetes or glucose intolerance. In 2024, a generic version by Teva Pharmaceuticals entered the market, adding competition, and Corcept itself has released a generic version as well. Other approved options include S IGNIFOR and SIGNIFOR LAR, ISTURISA, and RECORLEV. In addition, off-label drugs like ketoconazole, metyrapone, cabergoline, mitotane, and etomidate are also used in the U.S., with some marketed in Europe by HRA Pharma. SIGNIFOR (pasireotide), developed by Recordati, was the first drug specifically approved for Cushing's disease by the FDA in 2012, and also gained EU approval. Recordati also markets SIGNIFOR LAR, a long-acting injectable version approved by the FDA and Japan's PMDA in 2018. This formulation, administered intramuscularly once every four weeks, shares the same mechanism as SIGNIFOR but offers a different delivery route. Recordati is recognized as a leading player in this therapeutic area. Another key product from the company is ISTURISA (osilodrostat), the first FDA-approved oral drug that inhibits cortisol production by targeting the enzyme 11β-hydroxylase (CYP11B1), which is involved in the final step of cortisol synthesis. Its oral administration makes it more convenient for patients compared to injectable therapies. ISTURISA is also being studied for pediatric use in an ongoing Phase II trial (NCT03708900). RECORLEV, originally developed by Strongbridge Biopharma and later acquired by Xeris Pharmaceuticals, was approved by the FDA in 2021. It is indicated for adults with endogenous Cushing's syndrome who are not surgical candidates or did not achieve a cure through surgery. Unlike ISTURISA, RECORLEV works by inhibiting cortisol production at multiple points in the steroidogenesis pathway, offering a distinct mechanism of action. To know more about Cushing's disease treatment guidelines, visit @ Cushing's Disease Management Cushing's Disease Pipeline Therapies and Key Companies Relacorilant (CORT125134): Corcept Therapeutics Clofutriben (SPI-62): Sparrow Pharmaceuticals Atumelnant (CRN04894): Crinetics Pharmaceuticals Lu AG13909: H. Lundbeck ST-002: Stero Therapeutics Discover more about Cushing's disease drugs in development @ Cushing's Disease Clinical Trials Cushing's Disease Market Dynamics The Cushing's disease market dynamics are expected to change in the coming years. Although Cushing's disease is generally considered a rare condition, growing awareness and recent advances in research suggest that diagnoses may rise in the future; despite a seemingly crowded market, many current hypercortisolism treatments fail to normalize cortisol levels effectively and pose significant side effects highlighting a substantial opportunity for innovation, especially given the limited therapies specifically targeting Cushing's disease and the potential of newer oral alternatives like ISTURISA and RECORLEV to offer greater flexibility compared to SC and intramuscular options such as SIGNIFOR and SIGNIFOR LAR. Furthermore, potential therapies are being investigated for the treatment of Cushing's disease, and it is safe to predict that the treatment space will significantly impact the Cushing's disease market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the Cushing's disease market in the 7MM. However, several factors may impede the growth of the Cushing's disease market. Due to non-specific guidelines and recommendations, patients with Cushing's disease often face suboptimal care, delayed diagnosis, and inconsistent treatment approaches, further compounded by the diagnostic complexity, frequent misdiagnosis, and symptom overlap with more common conditions, which leave many undiagnosed or untreated; while existing therapies such as ketoconazole and metyrapone approved in Europe based on limited retrospective data and used off-label in the US despite high costs are widely trusted and entrenched in clinical practice, posing a significant barrier to the adoption of emerging therapies. Moreover, Cushing's disease treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Cushing's disease market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Cushing's disease market growth. Scope of the Cushing's Disease Market Report Therapeutic Assessment: Cushing's Disease current marketed and emerging therapies Cushing's Disease Market Dynamics: Key Market Forecast Assumptions of Emerging Cushing's Disease Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Cushing's Disease Market Access and Reimbursement Download the report to understand which factors are driving Cushing's disease market trends @ Cushing's Disease Market Trends Table of Contents Related Reports Cushing's Syndrome Market Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Cushing's syndrome companies including Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others. Cushing's Syndrome Pipeline Cushing's Syndrome Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Cushing's syndrome companies, including Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others. Endogenous Cushing's Syndrome Market Endogenous Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endogenous Cushing's syndrome companies including Corcept Therapeutics, Crinetics Pharmaceuticals, Sparrow Pharmaceuticals, among others. Endogenous Cushing's Syndrome Pipeline Endogenous Cushing's Syndrome Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endogenous Cushing's syndrome companies, including Corcept Therapeutics, Crinetics Pharmaceuticals, Sparrow Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准孤儿药临床2期

2025-05-05

·Business Wire

CORCEPT THERAPEUTICS ANNOUNCES FIRST QUARTER FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat serious endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today reported its results for the quarter ended March 31, 2025. Financial Results “In the first quarter, we had another record number of prescriptions from new and existing prescribers, broadly distributed throughout the country. Growing physician awareness of hypercortisolism has resulted in increased screening and treatment of patients with this devastating disease. Our specialty pharmacy vendor began the quarter unable to fulfill this surge in demand, which negatively affected our first quarter financial results. Pharmacy operations improved substantially in March and April, with each month setting a record for tablets dispensed. We are reiterating our 2025 revenue guidance of $900 – $950 million,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. Corcept’s first quarter 2025 revenue was $157.2 million, compared to $146.8 million in the first quarter of 2024. First quarter 2025 operating expenses were $153.8 million, compared to $117.3 million in the same period last year. Net income was $20.5 million in the first quarter of 2025, compared to $27.8 million in the first quarter of 2024. Cash and investments were $570.8 million at March 31, 2025, compared to $603.2 million at December 31, 2024. The balance at March 31, 2025 reflects the acquisition of $43.3 million of common stock in the first quarter pursuant to the company’s stock repurchase program, net exercise of employee stock options and net vesting of restricted stock grants. Clinical Development “Our New Drug Application (NDA) for relacorilant in hypercortisolism is progressing towards approval by the end of this year. We will submit our NDA next quarter for relacorilant in platinum-resistant ovarian cancer. We expect that relacorilant will have a role in helping treat earlier stages of ovarian cancer and other tumors that express the glucocorticoid receptor and have already begun our next clinical trial, BELLA. Meanwhile, we are making progress in understanding the role of cortisol modulation to treat a broad range of other serious disorders, including ALS and Metabolic Dysfunction-Associated Steatohepatitis (MASH),” added Dr. Belanoff. Hypercortisolism (Cushing’s Syndrome) “The positive results from our pivotal GRACE, GRADIENT, long-term extension and Phase 2 studies provide powerful support for the NDA for relacorilant in hypercortisolism. Patients in these studies experienced clinically significant improvements in a wide array of the signs and symptoms of hypercortisolism, without the off-target effects and toxicities that accompany currently available treatments. Relacorilant has the potential to become the new standard of care for patients with hypercortisolism,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “CATALYST is a landmark study that will change the way physicians treat some of their sickest patients. Its findings are striking: One in four patients whose diabetes resists treatment with the best available medications have hypercortisolism; hyperglycemia in these patients responds powerfully to treatment with a cortisol modulator. We reached an important milestone with the publication of CATALYST’s prevalence phase results in Diabetes Care and look forward to presenting the full results of the study’s treatment phase at ADA next month,” added Dr. Guyer. “Building on the insights from CATALYST, our MOMENTUM study will deepen physicians' understanding of hypercortisolism as a cause of resistant hypertension.” Oncology “The ROSELLA results are an important advance for patients with platinum-resistant ovarian cancer, a disease with few treatment options. The PFS and OS improvements demonstrated in ROSELLA, with no increase in safety burden, bring us closer to delivering a new standard of care for these patients. We look forward to presenting the full results from ROSELLA in a late-breaker session at ASCO and submitting our NDA next quarter,” said Dr. Guyer. “We are building on the findings from ROSELLA with our BELLA study, which will examine whether combining relacorilant with two medications – nab-paclitaxel and bevacizumab – will offer patients with platinum-resistant ovarian cancer another potent treatment option.” Amyotrophic Lateral Sclerosis (ALS) “ALS is a devastating disease. Patients who received dazucorilant did not show improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R), which was DAZALS’ primary endpoint. An improvement in overall survival, first seen at the six-month mark, was also observed at year one of the study. An exploratory analysis determined that patients who received 300 mg of dazucorilant at the start of the study lived significantly longer than patients who received placebo and did not switch to dazucorilant in the long-term extension study, with a hazard ratio of 0.16 (p-value: 0.0009). This long-term extension study is on-going. We will immediately seek input from U.S. and European regulatory authorities on the next steps with dazucorilant,” said Dr. Guyer. Metabolic Dysfunction-Associated Steatohepatitis (MASH) “In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures and was well-tolerated. We look forward to building on these promising results in our MONARCH study. First results are expected by the end of next year,” said Dr. Guyer. Conference Call We will hold a conference call on May 5, 2025, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com. 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 include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym, relacorilant, miricorilant, dazucorilant and our other product candidates; our investigational compounds’ clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. 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 those concerning: trends in medical practice, including trends regarding the identification and treatment of patients with hypercortisolism; our 2025 revenue guidance and factors that may affect our revenue and continued revenue growth, such as increased uptake or price reductions in competing medications, including generic versions of Korlym, and the performance of our third-party pharmacy and other vendors; relacorilant as a treatment for patients with hypercortisolism and ovarian and other cancers, dazucorilant as a treatment for patients with ALS, miricorilant as a treatment for patients with MASH; the timing and outcome of relacorilant’s NDAs and planned MAA in hypercortisolism and ovarian cancer; the timing and outcome of our CATALYST, MOMENTUM, ROSELLA, BELLA, DAZALS and MONARCH trials and their impact on patient care and Corcept’s commercial prospects; and the accrual and attributes of our clinical data. We disclaim any intention or duty to update forward-looking statements made in this press release. CORCEPT THERAPEUTICS INCORPORATED CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) March 31, 2025 December 31, 2024(1) (Unaudited) Assets Cash and investments $ 570,804 $ 603,165 Trade receivables, net of allowances 61,819 53,976 Inventory 15,534 15,995 Operating lease right-of-use asset 5,147 5,324 Deferred tax assets, net 144,445 130,914 Other assets 48,706 31,179 Total assets $ 846,455 $ 840,553 Liabilities and Stockholders’ Equity Accounts payable $ 27,947 $ 15,376 Operating lease liabilities 6,835 6,936 Other liabilities 128,388 138,652 Stockholders’ equity 683,285 679,589 Total liabilities and stockholders’ equity $ 846,455 $ 840,553 (1) Derived from audited financial statements at that date CORCEPT THERAPEUTICS INCORPORATED CONDENSED CONSOLIDATED STATEMENTS OF INCOME (In thousands, except per share data) Three Months Ended March 31, 2025 2024 Revenues Product revenue, net $ 157,214 $ 146,808 Operating expenses Cost of sales 2,403 2,535 Research and development 60,735 58,505 Selling, general and administrative 90,660 56,268 Total operating expenses 153,798 117,308 Income from operations 3,416 29,500 Interest and other income 6,202 5,493 Income before income taxes 9,618 34,993 Income tax benefit (expense) 10,929 (7,231 ) Net income $ 20,547 $ 27,762 Net income attributable to common stockholders $ 20,288 $ 27,514 Basic net income per common share $ 0.19 $ 0.27 Diluted net income per common share $ 0.17 $ 0.25 Weighted-average shares outstanding used in computing net income per common share Basic 104,106 102,791 Diluted 119,819 109,915

临床结果临床1期临床2期上市批准财报

2025-04-26

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ASCO 2025丨一文了解妇科肿瘤口头报告

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ASCO 2025 微专辑扫描二维码可查看更多内容2025年美国临床肿瘤学年会（ASCO 2025）将于5月30-6月3日在美国芝加哥举行。日前，ASCO公布了本次大会的摘要题目和大会日程，本刊整理了妇科肿瘤领域的口头报告专场（Oral Abstract Session）和快速口头报告（Rapid Oral Abstract Session）专场标题，供读者参考。口头报告专场TRUST: Trial of radical upfront surgical therapy in advanced ovarian cancer (ENGOT ov33/AGO‐OVAR OP7).TRUST：晚期卵巢癌根治性前期手术治疗试验（ENGOT ov33/AGO‐OVAR OP7）汇报者：Sven Mahner丨慕尼黑路德维希马克西米利安大学医院摘要号：LBA5500Sentinel lymph node biopsy versus pelvic lymphadenectomy in cervical cancer: The PHENIX trial宫颈癌前哨淋巴结活检 vs 盆腔淋巴结清扫术对比：PHENIX试验汇报者：刘继红丨中山大学肿瘤防治中心摘要号：LBA5501Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses.循环肿瘤DNA（ctDNA）超灵敏检测和追踪及其与局部晚期宫颈癌患者复发和生存的关系：III期CALLA试验分析汇报者：Jyoti Mayadev丨加州大学圣地亚哥医学中心摘要号：5502Patient-reported outcomes (PROs) in locally advanced cervical cancer (LACC): Insights from the OUTBACK trial.OUTBACK试验中局部晚期宫颈癌的患者报告结局(PRO) 汇报者：Linda R. Mileshkin丨彼得·麦卡勒姆癌症中心摘要号：5503Pembrolizumab with chemoradiotherapy in patients with high-risk locally advanced cervical cancer: Final analysis results of the phase 3, randomized, double-blind ENGOT-cx11/GOG-3047/KEYNOTE-A18 study.帕博利珠单抗联合放化疗治疗高危局部晚期宫颈癌患者：III期随机双盲ENGOT-cx11/GOG-3047/KEYNOTE-A18 研究的最终分析结果汇报者：Linda R. Duska丨弗吉尼亚大学医学院摘要号：LBA5504FIRST/ENGOT-OV44: A phase 3 clinical trial of dostarlimab (dost) and niraparib (nira) in first-line (1L) advanced ovarian cancer (aOC).FIRST/ENGOT-OV44：dostarlimab和尼拉帕利一线治疗晚期卵巢癌的III期临床试验汇报者：Anne-Claire Hardy-Bessard丨Armoricain肿瘤中心摘要号：LBA5506ROSELLA: 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).ROSELLA：评估relacorilant+白蛋白结合型紫杉醇vs.白蛋白结合型紫杉醇单药治疗铂耐药卵巢癌的III期研究（GOG-3073、ENGOT-ov72）汇报者：Alexander Olawaiye丨匹兹堡大学医学院和麦吉妇女医院摘要号：LBA5507Benmelstobart plus carboplatin/paclitaxel with or without anlotinib, followed by maintenance benmelstobart with or without anlotinib, as first-line treatment for advanced or recurrent endometrial cancer: A randomized, open-label, phase II trial. 贝莫苏拜单抗联合卡铂/紫杉醇±安罗替尼，随后贝莫苏拜单抗±安罗替尼维持治疗用于晚期或复发性子宫内膜癌一线治疗：一项随机、开放标签、II期临床试验汇报者：陈晓军丨上海市第十人民医院摘要号：5508 快速口头摘要专场Cadonilimab plus platinum-based chemotherapy ± bevacizumab for persistent, recurrent, or metastatic cervical cancer: Subgroup analyses of COMPASSION-16.卡度尼利单抗联合含铂化疗±贝伐珠单抗治疗持续性、复发性或转移性宫颈癌：COMPASSION-16 亚组分析汇报者：吴小华丨复旦大学附属肿瘤医院摘要号：5509Nimotuzumab combined with chemotherapy in the first-line treatment for patients with stage IVB, recurrent or persistent cervical squamous cell carcinoma: A multi-center, randomized, double-blind, and controlled study.尼妥珠单抗联合化疗用于IVB期、复发性或持续性宫颈鳞癌一线治疗：一项多中心、随机、双盲、对照研究汇报者：Zexuan Liu丨中国医学科学院肿瘤医院摘要号：5510Primary results of a phase 2 study of cisplatin-sensitized radiation therapy and pembrolizumab for unresectable vulvar cancer.顺铂增敏放射治疗和帕博利珠单抗治疗不可切除外阴癌的II期研究的主要结果汇报者：Oladapo O. Yeku丨麻省总医院、哈佛医学院摘要号：5511Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer: Longitudinal changes in circulating tumor DNA.度伐利尤单抗联合卡铂/紫杉醇，后续使用度伐利尤单抗±奥拉帕利作为子宫内膜癌的一线治疗：循环肿瘤DNA的纵向变化汇报者：Shannon Neville Westin丨德克萨斯大学MD安德森癌症中心摘要号：5512Phase 2 study of letrozole, abemaciclib, and metformin in estrogen receptor (ER)–positive recurrent endometrial cancer (EC).来曲唑、阿贝西利和二甲双胍治疗雌激素受体(ER)阳性复发性子宫内膜癌的II期研究汇报者：Panagiotis A. Konstantinopoulos丨丹娜—法伯癌症研究所摘要号：5513Safety and preliminary efficacy from a phase 1 study of INCB123667, a selective CDK2 inhibitor, in patients with advanced platinum-resistant and refractory ovarian cancer (OC).I期研究中选择性CDK2抑制剂INCB123667治疗晚期铂耐药/难治性卵巢癌患者的安全性和初步疗效汇报者：Domenica Lorusso丨Agostino Gemelli 大学医院基金会 IRCCS摘要号：5514A phase II trial of pembrolizumab and lenvatinib in recurrent or persistent clear cell ovarian carcinoma (NCT05296512).帕博利珠单抗和仑伐替尼治疗复发性或持续性透明细胞卵巢癌的II期试验汇报者：Joyce F. Liu丨丹娜—法伯癌症研究所摘要号：5515A phase I/II study of the safety and efficacy of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian cancer (EOC): Updated survival analysis from OVATION-2 trial.评估腹膜内注射IMNN-001联合紫杉醇/卡铂新辅助化疗治疗新诊断晚期上皮性卵巢癌的安全性和有效性的I/II期研究：来自OVATION-2试验的最新生存分析汇报者：Premal H. Thaker丨华盛顿大学医学院摘要号：5516Safety and efficacy of BAT8006, a folate receptor α (FRα) antibody drug conjugate, in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial.叶酸受体α（FRα）抗体药物偶联物BAT8006用于铂耐药卵巢癌患者的安全性和有效性：BAT-8006-001-CR试验的剂量优化/扩展队列更新汇报者：张松灵丨吉林大学第一医院摘要号：5517（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议临床结果临床3期

100 项与 Relacorilant 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11336	Relacorilant	-	DB14976

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
库欣综合征	申请上市	美国	Corcept Therapeutics, Inc.	2024-12-30
腹膜癌	临床3期	美国	Corcept Therapeutics, Inc.	2022-06-29
腹膜癌	临床3期	阿根廷	Corcept Therapeutics, Inc.	2022-06-29
腹膜癌	临床3期	澳大利亚	Corcept Therapeutics, Inc.	2022-06-29
腹膜癌	临床3期	比利时	Corcept Therapeutics, Inc.	2022-06-29
腹膜癌	临床3期	巴西	Corcept Therapeutics, Inc.	2022-06-29
腹膜癌	临床3期	加拿大	Corcept Therapeutics, Inc.	2022-06-29
腹膜癌	临床3期	法国	Corcept Therapeutics, Inc.	2022-06-29
腹膜癌	临床3期	匈牙利	Corcept Therapeutics, Inc.	2022-06-29
腹膜癌	临床3期	以色列	Corcept Therapeutics, Inc.	2022-06-29

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03776812 (CTgov)	临床2期	复发性铂耐药性原发性腹膜癌 \| 复发性卵巢癌 \| 复发性原发性腹膜癌 ... 更多	178	Nab-paclitaxel+Relacorilant (Arm A: Continuous Relacorilant Dosing)	顧襯積製鹽網衊鹹獵鏇(積齋遞艱製製夢鹹糧觸) = 夢齋窪膚艱範網顧觸齋構願餘顧積觸淵夢衊糧 (選製願範衊鏇選廠窪衊, 齋襯衊襯觸簾繭遞顧鑰 ~ 壓獵衊製蓋簾遞鬱夢夢) 更多	-	2025-04-30
				Nab-paclitaxel+Relacorilant (Arm B: Intermittent Relacorilant Dosing)	顧襯積製鹽網衊鹹獵鏇(積齋遞艱製製夢鹹糧觸) = 鑰淵構壓窪糧鑰醖蓋襯構願餘顧積觸淵夢衊糧 (選製願範衊鏇選廠窪衊, 繭簾膚選糧積願餘淵顧 ~ 鹽選糧壓廠鹽鏇壓觸齋) 更多
NCT03697109 (GRACE, CTgov)	临床3期	内源性库欣综合征	152	Relacorilant (Relacorilant (RW Phase))	艱構廠襯構餘壓憲築廠 = 網襯鹹選醖糧廠鬱積製壓廠鹹廠鏇窪夢衊顧遞 (構鏇構壓憲鏇顧遞壓膚, 鑰顧範淵鬱鏇顧鏇壓鹽 ~ 選襯網鹹膚鹽壓夢夢齋) 更多	-	2025-04-24
				Placebo (Placebo (RW Phase))	艱構廠襯構餘壓憲築廠 = 選餘膚廠蓋鑰製積遞簾壓廠鹹廠鏇窪夢衊顧遞 (構鏇構壓憲鏇顧遞壓膚, 鬱遞願膚衊夢遞膚積顧 ~ 遞鏇鏇廠夢獵製鹽鏇繭) 更多
NCT05257408 (ROSELLA, Company_Website) 人工标引	临床3期	铂耐药性卵巢癌	381	Relacorilant + nab-paclitaxel	壓衊齋觸鏇網廠襯壓蓋(顧構壓築鹹齋鹹簾鏇獵) = 簾艱範願夢廠網淵遞淵蓋遞鑰壓糧淵窪衊衊餘 (築繭範淵憲遞獵醖築壓 ) 达到更多	积极	2025-03-31
				Nab-paclitaxel	壓衊齋觸鏇網廠襯壓蓋(顧構壓築鹹齋鹹簾鏇獵) = 選鏇願壓願積窪夢蓋糧蓋遞鑰壓糧淵窪衊衊餘 (築繭範淵憲遞獵醖築壓 ) 达到更多
NCT03604198 (BusinessWire) 人工标引	临床3期	库欣综合征	116	Relacorilant	積襯獵鹹糧構獵壓糧憲(願膚窪齋繭觸簾構襯築) = 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. 遞衊廠襯齋夢鑰醖糧醖 (網遞選襯鏇廠簾膚願衊 ) 更多	积极	2024-12-16
NCT03604198 (Company_Website) 人工标引	临床2期	库欣综合征	53	Relacorilant	鏇製壓糧艱積鏇淵襯襯(製艱網構壓膚鬱選齋築) = 觸膚窪壓窪醖衊選鏇衊艱齋窪簾壓選淵鹹範壓 (衊糧鏇廠衊鹹艱願夢構 ) 更多	积极	2024-11-25
NCT04308590 (GRADIENT, Biospace) 人工标引	临床3期	库欣综合征	137	relacorilant	鹽膚構餘艱襯簾廠鹹衊(夢蓋鏇憲艱積構蓋鹽積) = 廠壓製壓觸製鹽築艱遞選鏇艱鏇艱繭鹹範顧憲 (觸衊廠艱鑰齋遞窪鬱醖 ) 达到	积极	2024-10-30
				Placebo	鹽膚構餘艱襯簾廠鹹衊(夢蓋鏇憲艱積構蓋鹽積) = 觸繭鬱餘選壓鏇製觸衊選鏇艱鏇艱繭鹹範顧憲 (觸衊廠艱鑰齋遞窪鬱醖 ) 达到
NCT02804750 \| NCT00280475 (Pubmed \| J Endocrinol Invest)	临床2期	库欣综合征 factor VIII \| activated partial thromboplastin time \| platelet count ... 更多	34	Relacorilant (Surgery)	網鏇窪繭齋鹽襯鬱鹽顧(鑰鹹壓壓願繭觸鹹醖膚) = 糧窪鬱糧鏇膚壓齋積膚窪鏇衊壓醖構膚積齋衊 (糧夢繭蓋壓獵鹽蓋範簾 )	积极	2024-09-21
NCT03697109 (GRACE, ENDO2024)	临床3期	库欣综合征	152	Relacorilant 100 mg QD	窪衊構顧廠壓壓繭餘淵(遞衊獵觸壓壓鑰鏇鏇醖) = 齋製廠夢餘獵衊獵襯鑰膚顧鏇憲簾淵襯壓願鹽 (鑰網餘蓋繭鑰鹹願憲網, 6.7) 更多	积极	2024-06-01
NCT03697109 (GRACE, Company_Website) 人工标引	临床3期	库欣综合征	-	relacorilant	繭築願鏇築簾壓遞獵醖(醖遞鏇鏇蓋構夢鏇壓選) = GRACE met its primary endpoint of loss of blood pressure control in the randomized withdrawal phase among patients receiving relacorilant as compared to placebo 壓鏇廠廠醖獵壓淵餘簾 (鹹鹽齋顧構遞網鏇構夢 ) 达到更多	积极	2024-05-28
				placebo
NCT03697109 (GRACE, GlobeNewswire) 人工标引	临床3期	内源性库欣综合征	152	relacorilant	願顧廠網觸鹹願築製顧(鏇鏇壓蓋範製製觸窪願) = 淵夢廠範艱鬱襯鹽鑰糧廠鹹齋範選鹽廠廠鏇蓋 (觸憲觸糧遞廠壓範醖艱 ) 更多	积极	2024-04-22
				relacorilant (withdrawal phase)	願顧廠網觸鹹願築製顧(鏇鏇壓蓋範製製觸窪願) = 鹹夢糧齋餘顧蓋廠壓餘廠鹹齋範選鹽廠廠鏇蓋 (觸憲觸糧遞廠壓範醖艱 ) 更多