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）

2025-06-03

·医学新视点

生存结局双重获益，总生存期近16个月！这类卵巢癌或有新标准治疗方案 | 2025 ASCO速递

卵巢癌是女性癌症死亡的第五大原因。手术联合铂类化疗仍然是上皮性卵巢癌的标准治疗方式，但由于化疗耐药和缺乏有效筛查手段，卵巢癌患者总体生存仍不理想。在停铂类化疗后6个月内或联合铂化疗中出现进展的复发性卵巢癌称为铂耐药复发性卵巢癌（PROC），这部分患者往往面临着治疗选择有限、疗效欠佳以及预后不良等问题。Relacorilant是“first-in-class”的选择性糖皮质激素受体拮抗剂，可通过减少皮质醇信号传导来增加肿瘤对化疗的敏感性。在备受关注的2025年美国临床肿瘤学会年会（2025 ASCO）上，ROSELLA（GOG-3073/ENGOT-ov72）的研究结果发表，表明在铂耐药复发性卵巢癌中，相较于白蛋白结合型紫杉醇单药治疗，relacorilant联合白蛋白结合型紫杉醇治疗方案可显著延长患者无进展生存期（PFS，6.54个月 vs. 5.52个月）和总生存期（OS，15.97个月 vs. 11.50个月），且安全性可控，有望成为这类患者潜在新的标准治疗方案。该研究入选了本届ASCO的最新科学进展（Late Breaking Abstracts，LBA），结果同步发表于《柳叶刀》（The Lancet）。截图来源：ASCO这项国际多中心、开放标签、随机对照3期试验在14个国家的117家医疗中心开展，共纳入381例铂耐药复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌患者（允许既往≤3线治疗且接受过贝伐珠单抗后疾病进展，或是对最新治疗方案不耐受）。研究人员将患者以1：1的比例随机分配至以下两组：联合治疗组（188例）：relacorilant（分别于白蛋白结合型紫杉醇输注前1天、当天及后1天，口服用药，剂量150 mg）+白蛋白结合型紫杉醇（80 mg/m²，分别于第1、8、18天静脉注射用药，以28天为一个周期）；单药治疗组（193例）：白蛋白结合型紫杉醇单药治疗（100 mg/m²，给药频次、周期等方案同联合治疗组）。研究双重主要终点为盲法独立中心以RECIST 1.1为标准评估的PFS和OS。研究结果显示，相比于单药治疗组，联合治疗组中位PFS显著更长（6.54个月 vs. 5.52个月），联合治疗组疾病进展或死亡风险显著降低30%（HR=0.70，95%CI：0.54~0.91，P=0.0076）。联合治疗组中位OS也显著长于单药治疗组（15.97个月 vs. 11.50个月），联合治疗组死亡风险显著降低31%（HR=0.69，95%CI：0.52~0.92，P=0.0121）。安全性方面，两组不良事件发生率相似，主要为贫血、中性粒细胞减少症和恶心。未观察到新的安全性信号。文章表示，该研究“首次”证实相比于标准紫杉烷类治疗，relacorilant联合白蛋白结合型紫杉醇方案可为铂耐药复发性卵巢癌患者带来PFS与OS双重获益。鉴于当前获得的积极疗效数据和可控安全性，该方案有望成为铂耐药复发性卵巢癌潜在的新的标准治疗方案，为临床治疗提供更多选择。点击文末“阅读原文/Read more”，即可访问ASCO官网阅读摘要。推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料[1]ROSELLA Investigators. (2025). Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. The Lancet. Advance online publication. https://doi-org.libproxy1.nus.edu.sg/10.1016/S0140-6736(25)01040-2[2]田东立，李芳梅，芦恩婷，等.铂耐药复发性卵巢癌诊治中国专家共识(2025年版)[J].肿瘤学杂志, 2025, 31(2):83-93.DOI:10.11735/j.issn.1671-170X.2025.02.B001.免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知

临床结果ASCO会议临床3期

2025-06-02

·ioncology

ASCO现场直击丨Dr. Olawaiye汇报ROSELLA研究结果：铂耐药卵巢癌或将迎来新选择

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近几年来，靶向叶酸受体α（FRα）的新药（例如mirvetuximab soravtansine-gynx）为FRα高表达的铂耐药上皮性卵巢癌、输卵管癌或原发性腹膜癌经治患者带来新希望；然而没有该生物标志物的患者仍然需要其他选择。根据近期发布的随机、全球多中心、开放标签III期ROSELLA试验结果，在既往接受过1-3线全身抗癌治疗（包括贝伐珠单抗）的复发性、铂耐药、高级别浆液性上皮性卵巢癌患者中，选择性糖皮质激素受体（GR）拮抗剂Relacorilant联合白蛋白结合型紫杉醇化疗组相比对照组（单用化疗）改善无进展生存（PFS），经盲态独立中心审查（BICR）评估的中位PFS分别为6.5个月和5.5个月（风险比[HR]为0.70；P=0.008）。中期分析显示，总生存期（OS）在临床上显著改善（HR=0.69，中位数分别为16.0个月vs 11.5个月，P=0.01）。各研究组的不良事件 (AE) 相似，Relacorilant + 白蛋白结合型紫杉醇方案耐受性良好，未出现新的安全信号。最常见的报告不良事件是白蛋白结合型紫杉醇的已知毒性：贫血 (58%)、中性粒细胞减少 (56%) 和恶心 (39%)。在2025年美国临床肿瘤学会（ASCO）年会上，来自匹兹堡大学医学院、麦吉妇女医院妇科肿瘤组的Alexander Olawaiye教授将以口头报告（摘要号LBA5507）形式汇报更详细的研究数据。在报告发布前，《肿瘤瞭望》现场特邀Olawaiye教授就ROSELLA研究的发现与临床意义进行探讨。《肿瘤瞭望》：根据ROSELLA研究的最新结果（LBA5507），Relacorilant联合白蛋白结合型紫杉醇治疗铂耐药卵巢癌患者的疗效和安全性如何？ Dr. Olawaiye：ROSELLA试验有两个主要终点：一是无进展生存期；二是总生存期。两个主要终点的意思是，只要其中一个终点呈阳性，试验结果就会呈阳性。无进展生存终点的结果已经出来了，这就是我们将在2025 ASCO会议发布的内容。Relacorilant组和对照组的PFS差异具有非常显著的统计学意义，PFS风险比为0.7，有利于Relacorilant组。这意味着疾病进展或死亡风险降低了30%。ROSELLA试验的总生存期数据尚不成熟，但我们已经开始看到生存曲线分离。总生存期的风险比为0.69，这意味着死亡风险降低了 31%。这些研究发现非常引人注目，也非常令人兴奋。 Dr. Olawaiye: This trial had a dual primary endpoint. One, progression-free survival. Two, overall survival. What dual primary endpoints meant is if either endpoint was positive, the trial would be positive. So, the progression-free survival endpoint has already read out, and that is what we presented, there is a highly statistically significant difference in progression free survival between the two arms of the trial. The hazard ratio for progression free survival is 0.7 in favor of the relacorilant arm. This represents a 30% reduction in the hazard of progression of disease or death. The overall survival data is not yet mature, but we have already begun to see the curves separate. The hazard ratio for overall survival is 0.69, which again, is a 31% reduction in the hazard of death. These findings are very compelling, and they are very exciting.（上下滑动可查看）《肿瘤瞭望》：鉴于FRα检测组织样本的时效性挑战，Relacorilant方案不需要生物标志物筛选患者，这是否会对资源有限的地区特别有利？Dr. Olawaiye：是的，这正是Relacorilant方案令人兴奋的地方。不需要生物标志物的筛选，这是一件好事。靶向FRα的药物治疗卵巢癌很有效，然而，只有一部分患者的癌症表达高水平的FRα，因此Relacorilant这种新药的独特之处在于无需进行生物标志物筛选。如果患者患有铂耐药卵巢癌，当该组合方案可用时，他们有资格接受Relacorilant 与白蛋白结合型紫杉醇 (nab-paclitaxel) 的联合治疗。正如您所知，该药物尚未获得 FDA 批准，但我们对此充满希望。Dr. Olawaiye: Yes. Again, that is what is exciting about it. For biomarker selection, that is a good thing. The folate receptor-alpha (FRα) targeting drug is very good, however, only a percentage of patients’ cancer express high levels of FRα, so the uniqueness of this new medication, relacorilant, is that there is no necessity for biomarker selection. If the patient has platinum-resistant ovarian cancer, they are eligible to be treated with relacorilant combined with nab-paclitaxel when that combination is available. As you know, it is not yet FDA-approved, but we are hopeful.（上下滑动可查看）《肿瘤瞭望》：作为糖皮质激素受体拮抗剂，Relacorilant治疗对新发糖尿病/高血压是否有影响？Dr. Olawaiye：糖皮质激素信号传导实际上是促糖尿病发生的，这意味着如果某人糖皮质激素暴露过量，就会干扰正常糖代谢的能力。例如，如果给糖尿病患者服用糖皮质激素，他们的糖尿病就会变得非常难以控制。Relacorilant的作用机制则相反，其阻断糖皮质激素信号传导。虽然我们没有研究将Relacorilant作为糖尿病的治疗方法，但根据它的生物学原理，糖尿病或糖尿病控制困难不会成为Relacorilant的副作用。Relacorilant甚至可能有助于控制糖尿病。 Dr. Olawaiye: Glucocorticoid signaling is actually pro-diabetic, which means if somebody has too much glucocorticoid exposure, it disturbs the ability to metabolize sugar properly. For instance, if you give diabetic patients glucocorticoids, their diabetes becomes very difficult to control. Relacorilant functions in the opposite way. It blocks glucocorticoid signaling. Even though we did not study this as a treatment for diabetes, the biology of it is that diabetes or difficulty with diabetes control would not be a problem as a side effect of relacorilant. It may even help diabetes control.（上下滑动可查看）《肿瘤瞭望》：2025年ASCO发布了大量关于妇科肿瘤的研究结果，您认为哪些研究会对临床实践产生重大影响？Dr. Olawaiye：我认为ROSELLA是其中一项具有临床影响力的研究，因为，请记住，Relacorilant是治疗卵巢癌的首创（first-in-class）新药，意味着这是一种既往我们从未见过的药物。在其他即将在本次会议汇报的试验中，许多研究的是已在使用的药物——这些药物要么原本用于卵巢癌但现与其他药物联用，要么是已在其他癌症类型中确立疗效的药物。这项研究及其之前的两项先行研究代表了Relacorilant首次用于治疗任何癌症，我们对ROSELLA研究发现感到非常兴奋，并希望Relacorilant能成为铂耐药卵巢癌治疗的新标准。Dr. Olawaiye: ROSELLA is one of those studies that I think is going to be clinically impactful, because, remember that relacorilant is a first-in-class drug in ovarian cancer. We have never seen anything like it before. The other trials were that were presented, studied drugs that are already in use, either in ovarian cancer and now modified with another agent, or are already established in other cancers. This study and its previous two forerunners represent the first time relacorilant would be studied in any cancer. We are so excited about the findings, and we are hoping this is going to be a new standard in platinum-resistant ovarian cancer treatment.（上下滑动可查看）参考文献1.Olawaiye A, et al. ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). 2025 ASCO, LBA5507.（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期临床1期

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

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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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)	襯鏇鏇廠築選齋憲壓糧(鹹齋夢選餘廠築繭獵醖) = 築蓋壓艱觸鏇鹽顧壓廠顧淵觸網蓋襯鹽鏇鏇願 (簾糧廠憲艱衊顧獵艱艱, 鹹遞襯鑰繭獵餘憲襯膚 ~ 醖遞憲夢鹹繭鏇範壓選) 更多	-	2025-04-30
				Nab-paclitaxel+Relacorilant (Arm B: Intermittent Relacorilant Dosing)	襯鏇鏇廠築選齋憲壓糧(鹹齋夢選餘廠築繭獵醖) = 廠醖齋齋觸顧襯鑰糧鑰顧淵觸網蓋襯鹽鏇鏇願 (簾糧廠憲艱衊顧獵艱艱, 夢鑰鹹膚網遞齋簾窪製 ~ 築壓鹽構獵簾繭壓鏇鏇) 更多
NCT03697109 (GRACE, CTgov)	临床3期	内源性库欣综合征	152	Relacorilant (Relacorilant (RW Phase))	選憲觸顧醖窪鏇築窪築 = 顧膚襯衊醖艱鑰壓觸獵鬱顧衊願獵願顧鏇鹹獵 (鏇構選顧構淵獵製觸艱, 鬱觸夢鏇鹽糧繭膚淵製 ~ 積醖齋鏇築鬱築膚齋願) 更多	-	2025-04-24
				Placebo (Placebo (RW Phase))	選憲觸顧醖窪鏇築窪築 = 簾遞糧願製壓蓋蓋觸壓鬱顧衊願獵願顧鏇鹹獵 (鏇構選顧構淵獵製觸艱, 鬱遞鑰願糧願淵鹹願廠 ~ 窪艱願構獵鹹醖鹹簾襯) 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	選鹽齋襯蓋選蓋膚鹽鏇(醖遞憲鹽糧鹽膚構選餘) = 網鬱夢範網窪衊製鑰壓構廠膚網夢夢網壓簾壓 (網糧醖鏇觸築獵築鑰鑰 ) 达到更多	积极	2025-03-31
				Nab-paclitaxel	選鹽齋襯蓋選蓋膚鹽鏇(醖遞憲鹽糧鹽膚構選餘) = 範齋蓋蓋鏇壓蓋鬱齋網構廠膚網夢夢網壓簾壓 (網糧醖鏇觸築獵築鑰鑰 ) 达到更多
NCT03604198 (BusinessWire) 人工标引	临床3期	库欣综合征	116	Relacorilant	鹽積膚壓壓顧願構廠餘(壓鑰齋獵簾艱齋範選顧) = 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. 遞願製醖網鏇繭積願夢 (網鬱廠範衊鹽積鹹獵顧 ) 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	醖築鑰艱壓廠蓋簾壓遞(窪衊憲構齋醖鏇築襯憲) = 衊窪獵觸積膚餘廠鏇壓遞積齋顧顧衊艱遞蓋鏇 (廠遞選製膚憲鹹觸艱繭 ) 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	糧窪壓襯膚衊遞遞築簾(衊醖構憲膚醖廠選淵選) = 齋鏇鬱獵鏇廠築醖觸觸範製願襯顧鹽淵鹹壓醖 (壓襯鬱簾夢鹽艱觸鬱顧 ) 达到	积极	2024-10-30
				Placebo	糧窪壓襯膚衊遞遞築簾(衊醖構憲膚醖廠選淵選) = 範壓選鏇鏇蓋醖製製製範製願襯顧鹽淵鹹壓醖 (壓襯鬱簾夢鹽艱觸鬱顧 ) 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)	鏇顧鑰鏇願顧鏇鹽範獵(繭構艱觸鏇餘選鹹簾繭) = 繭膚夢艱製衊艱憲鬱鬱鑰遞構願觸獵觸鬱築製 (糧壓憲鑰範醖衊窪鹽淵 )	积极	2024-09-21
NCT03697109 (GRACE, ENDO2024)	临床3期	库欣综合征	152	Relacorilant 100 mg QD	衊襯顧衊壓夢構網醖醖(鹹鬱淵衊餘觸製觸壓憲) = 築膚鏇醖選膚壓淵淵衊齋築餘醖蓋顧淵獵夢構 (製鬱壓願構夢襯膚廠築, 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	夢憲範淵襯餘鬱壓網餘(窪醖鹽範獵鏇製憲網淵) = GRACE met its primary endpoint of loss of blood pressure control in the randomized withdrawal phase among patients receiving relacorilant as compared to placebo 壓顧繭築憲壓廠繭醖築 (顧積選廠網壓構網獵夢 ) 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	觸齋繭齋艱鹹築製夢壓(觸獵鏇鏇鹹範積觸鹹範) = 網憲構積淵鑰廠壓憲構醖糧鏇廠餘觸願淵廠壓 (範齋築顧製廠築艱鑰繭 ) 更多	积极	2024-04-22
				relacorilant (withdrawal phase)	觸齋繭齋艱鹹築製夢壓(觸獵鏇鏇鹹範積觸鹹範) = 鑰獵齋蓋醖觸繭鏇醖範醖糧鏇廠餘觸願淵廠壓 (範齋築顧製廠築艱鑰繭 ) 更多