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）

2025-08-01·PHYTOMEDICINE

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

Article

作者: Fang, Qunying ; Zong, Lu ; Han, Hui ; Wang, Jiawei ; Shui, Lijun ; Zhao, Shiyu ; 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.

2025-06-01·LANCET

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

Article

作者: Colombo, Nicoletta ; Diakos, Connie ; McCollum, Michael E ; Artioli, Grazia ; Hopp, Elizabeth ; Garbaos, Gabriel ; Van Gorp, Toon ; De La Cueva, Helena ; Oaknin, Ana ; Mileshkin, Linda ; Monk, Bradley J ; Scandurra, Giuseppa ; Balázs, Boglárka ; Salutari, Vanda ; Kang, Sokbom ; Leiser, Aliza L ; Pai, Sachin G ; Scaranti, Mariana ; Slomovitz, Brian ; Cassani, Chiara ; Devaux, Alix ; Gladieff, Laurence ; Lee, Yong Jae ; O'Malley, David M ; Bagaméri, Andrea ; Vergote, Ignace ; Kaczmarek, Emilie ; Bodnar, Lubomir ; You, Benoit ; Kesner-Hays, Amanda ; 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.

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.

项与 Relacorilant 相关的新闻（医药）

2025-07-18

·医学新视点

TOP 10潜在重磅疗法榜单公布，用于治疗肥胖、肺癌、心血管疾病等

▎药明康德行业媒体Evaluate发布了2025年生物医药产业趋势报告，列出了最新十项具有潜力的重磅研发项目。这些项目涵盖胃肠与内分泌、肿瘤、血液、呼吸等多个治疗领域，并涉及多种创新治疗模式。在这10款潜在重磅疗法中，小分子药物占据一半（5款，占比50%），多肽药物占3款（占比30%），抗体疗法占2款（占比20%）。这一分布不仅再次印证了小分子药物在生物医药领域的重要地位，也凸显了多肽疗法在该领域日益增长的影响力。研发项目：CagriSema研发公司：诺和诺德（Novo Nordisk）研发状态：REDEFINE-4临床3期试验的数据可能会在2025年下半年公布CagriSema是一款由长效胰淀素类似物cagrilintide（2.4 mg）和司美格鲁肽（2.4 mg）组成的固定剂量联合疗法，设计为每周一次皮下注射。今年6月，诺和诺德公布REDEFINE-2临床3期试验的结果，该研究评估了CagriSema联合生活方式干预对罹患2型糖尿病（T2D）成人肥胖患者的疗效与安全性。分析显示，在依从治疗方案的受试者群体中，治疗68周后，CagriSema组体重平均下降15.7%，而安慰剂组仅下降3.1%，两组间差异为12.6%。CagriSema组在体重下降超过5%、10%、15%和20%的患者比例方面，均显著优于安慰剂组（分别为83.6% vs 30.8%，65.6% vs 10.3%，43.9% vs 2.4%，22.9% vs 0.5%；p<0.001）。此结果与去年所公布的REDEFINE-1临床3期试验结果一致。另一项临床3期试验REDEFINE-4，则预计在2025年的下半年公布初步数据。研发项目：Orforglipron研发公司：礼来（Eli Lilly and Company）研发状态：ATTAIN-1与ATTAIN-2临床3期试验数据预计在2025年第三季度公布Orforglipron是礼来开发的一种每日一次的口服、非肽类GLP-1受体小分子激动剂。该药物是一种非肽分子，这使得它更容易被制造和包装成药片。这一特性还可能有助于提高其在患者中的可负担性和可及性。今年4月，礼来公布orforglipron的首个3期临床试验结果。数据显示，orforglipron可在不同剂量下将2型糖尿病成人患者的糖化血红蛋白（A1C）平均降低1.3至1.6个百分点；在最高剂量组中，患者平均体重减轻达16.0磅（7.9%）。根据新闻稿，orforglipron是首个完成3期临床试验的口服小分子GLP-1受体激动剂，标志着GLP-1药物开发的又一重要突破。而分别评估orforglipron在带有体重相关共病的肥胖或超重患者，以及在患有T2D的超重或肥胖患者中的临床3期试验ATTAIN-1与ATTAIN-2的初步结果，预计在今年第三季度公布。研发项目：Retatrutide研发公司：礼来研发状态：多项临床3期试验的数据预计在2026年上半年公布Retatrutide是礼来的在研靶向葡萄糖依赖性促胰岛素多肽、GLP-1和胰高血糖素受体的三重激动剂。在一项2期临床试验中，83%接受12 mg剂量retatrutide治疗的肥胖或超重成人患者在经过24周的治疗后，达成至少15%的体重下降。目前，retatrutide正在多项3期试验当中接受检视，用于治疗肥胖或超重患者，以及患有心血管疾病、2型糖尿病或膝关节骨关节炎的肥胖或超重患者。这些试验的结果预定在2026年上半年公布。研发项目：MariTide研发公司：安进（Amgen）研发状态：临床3期试验预计于2025年启动MariTide是一款潜在“first-in-class”的在研抗体多肽偶联药物，在靶向胃抑制肽受体（GIPR）的单克隆抗体的特定位点上偶联了两个GLP-1类似物，可在激活GLP-1受体的同时抑制GIPR。安进在今年6月公布MariTide临床2期试验第一部分的完整结果。MariTide在无2型糖尿病的肥胖人群中实现了最高约20%的平均体重减轻，而安慰剂组为2.6%；在患有糖尿病的肥胖人群中，MariTide组的体重平均减轻最高可达约17%，而安慰剂组仅为1.4%。在第52周时，体重减轻仍未出现平台期，显示出进一步减重的潜力。除了显著的减重效果外，MariTide还在患有糖尿病的肥胖人群中实现了最高达2.2个百分点的糖化血红蛋白持续且显著下降。研发项目：MK-3475A研发公司：默沙东（MSD）研发状态：已向FDA递交上市申请，PDUFA日期为2025年9月23日默沙东在今年3月报告了关键性3期临床试验3475A‑D77的数据。该研究评估了皮下注射的Keytruda（pembrolizumab）制剂MK-3475A与化疗联用的效果和安全性。该研究达到了主要终点：与静脉输注（IV）pembrolizumab联合化疗相比，MK-3475A联合化疗在药代动力学（PK）方面显示出非劣效性，且中位注射时间仅为2分钟。客观缓解率（ORR）、无进展生存期（PFS）、缓解持续时间（DOR）及安全性在两组之间保持一致。两组的中位总生存期均未达到。基于这些数据，美国FDA已接受为皮下给药pembrolizumab递交的生物制品许可申请（BLA），拟在pembrolizumab此前获批的所有实体瘤适应症中，新增皮下给药方式。研发项目：Ivonescimab研发公司：Summit Therapeutics、康方生物（Akesobio）研发状态：3期试验初步结果预计在2025年公布双特异性抗体ivonescimab是一款潜在“first-in-class”疗法，靶向PD-1和VEGF。今年5月，Summit Therapeutics宣布其全球3期临床试验HARMONi取得积极结果。盲态独立影像学审查委员会（BICR）评估的结果显示，ivonescimab联合化疗相比安慰剂联合化疗，显著延长了患者的PFS，风险比为0.52（95% CI：0.41–0.66，p<0.00001）。在总生存期（OS）方面，ivonescimab联合化疗组显示出风险比为0.79（95% CI：0.62–1.01，p=0.057）的积极趋势，进一步支持其在EGFR突变的晚期非小细胞肺癌（2L及以上）治疗中的潜力。研发项目：Relacorilant研发公司：Corcept Therapeutics研发状态：已向FDA递交上市申请，PDUFA日期为2025年9月23日Relacorilant是一种口服选择性糖皮质激素受体（GR）拮抗剂，通过与GR结合而非体内其他激素受体结合来调节皮质醇活性。今年3月，美国FDA已接受该公司为relacorilant递交的新药申请（NDA），用于治疗内源性高皮质醇症，又名库欣综合征（Cushing’s syndrome）。临床3期试验GRADIENT结果显示，有高血压的患者接受relacorilant治疗后，在22周时其平均收缩压较基线下降6.6 mm Hg（p=0.012），达到具有统计学显著性和临床意义的改善，而接受安慰剂的患者仅下降2.1 mm Hg。除了治疗内源性高皮质醇症，Corcept还在研究relacorilant在多种严重疾病中的应用。今年4月公布的关键3期试验ROSELLA结果显示，与单用紫杉醇的患者相比，接受relacorilant组合疗法的卵巢癌患者其疾病进展风险降低30%（HR=0.70；p=0.008）。联合治疗组的PFS为6.5个月，而紫杉醇单药组为5.5个月。在OS的中期评估中，联合治疗组患者的中位OS显著延长，为16.0个月，而紫杉醇单药组为11.5个月（HR=0.69；p=0.012）。基于这一积极结果，该公司计划向美国和欧盟的监管机构递交上市申请。研发项目：Milvexian研发公司：百时美施贵宝（Bristol Myers Squibb）与强生（Johnson & Johnson）研发状态：多项3期试验进展中Milvexian是一款口服凝血因子XIa抑制剂，接受评估其用于房颤、急性冠状动脉综合征以及中风患者中的作用。在2期AXIOMATIC-TKR试验中，milvexian在预防全膝关节置换术（TKR）后静脉血栓栓塞（VT）方面显示出良好效果。使用milvexian（每日一次200毫克）组的VT发生率最低，为7%，而此数值在活性对照药物（每日40毫克皮下注射）组为21%，风险降低超过60%。两组的出血率相近，均为4%。研发项目：Daraxonrasib（RMC-6236）研发公司：Revolution Medicines研发状态：全球3期关键性临床试验进行中Daraxonrasib是一款口服选择性抑制剂，能够靶向处于GTP结合（激活、ON）状态的突变型及野生型RAS蛋白。该疗法在今年6月获得FDA授予的突破性疗法认定，用于治疗既往接受治疗的、携带KRAS G12突变的转移性胰腺导管腺癌（PDAC）患者。该认定主要基于RMC-6236-001试验的积极数据。在37名携带RAS突变的PDAC患者中，Daraxonrasib作为二线疗法显示出显著的抗肿瘤活性。在KRAS G12X突变患者（n=22）中，患者的中位PFS为8.8个月（95% CI：8.5个月–不可估计[NE]），中位OS仍不可估计（95% CI：NE–NE）。而在携带任意RAS突变患者（n=37）中，中位PFS为8.5个月（95% CI：5.9个月–NE），中位OS仍不可估算（95% CI：8.5个月–NE）。此外，KRAS G12X突变患者6个月的生存率为100%，任意RAS突变患者则为97%。KRAS G12X突变患者的ORR为36%，任意RAS突变患者为27%。研发项目：Brensocatib研发公司：Insmed研发状态：已向FDA递交上市申请，PDUFA日期为2025年8月12日Brensocatib是一种口服、可逆性DPP1小分子抑制剂。DPP1是一种酶，负责激活中性粒细胞中的中性粒细胞丝氨酸蛋白酶（NSPs）。Brensocatib可通过抑制DPP1降低NSPs的活化，从而降低炎症性疾病（如支气管扩张）的组织损伤。这款疗法已经获得美国FDA授予的突破性疗法认定，用于治疗非囊性纤维化支气管扩张。一项包含1680名成人和41名青少年非囊性纤维化支气管扩张症患者的临床试验结果显示，试验达到主要终点，10 mg和25 mg剂量的brensocatib分别将患者的年化肺部症状恶化（PE）率降低21.1%和19.4%，统计学显著并具有临床意义。以上这些极具潜力的创新疗法，不仅展示了生物医药领域前沿科技的突破与发展，也为患者带来了新的治疗希望。我们期待这些研发项目在不久的将来顺利实现临床转化和上市审批，早日惠及更多患者。参考资料（可上下滑动查看）[1] 2025 World Preview: Pharma Growth Steady Amid Turbulent Seas and Rising China. Retrieved July 11, 2025 from https://www.evaluate.com/thought-leadership/2025-world-preview/[2] CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in NEJM. Retrieved from https://www.prnewswire.com/news-releases/cagrisema-2-4-mg--2-4-mg-demonstrated-22-7-mean-weight-reduction-in-adults-with-overweight-or-obesity-in-redefine-1--published-in-nejm-302487770.html[3] Ivonescimab Plus Chemotherapy Demonstrates Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with EGFR-Mutant Non-Small Cell Lung Cancer after EGFR TKI Therapy in Glo. Retrieved July 11, 2025 from https://www.smmttx.com/wp-content/uploads/2025/05/2025_PR_0530-_-HARMONi-Data-_-FINAL.docx.pdf[4] Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer. Retrieved July 12, 2025 from https://www.businesswire.com/news/home/20250331748780/en/Primary-Endpoint-Met-in-Corcepts-Pivotal-Phase-3-ROSELLA-Trial-of-Relacorilant-in-Patients-with-Platinum-Resistant-Ovarian-Cancer[5] Weitz JI, Strony J, Ageno W, Gailani D, Hylek EM, Lassen MR, Mahaffey KW, Notani RS, Roberts R, Segers A, Raskob GE; AXIOMATIC-TKR Investigators. Milvexian for the Prevention of Venous Thromboembolism. N Engl J Med. 2021 Dec 2;385(23):2161-2172. doi: 10.1056/NEJMoa2113194. Epub 2021 Nov 15. PMID: 34780683; PMCID: PMC9540352.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「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，传递医学新知

临床3期临床结果

2025-07-15

·药明康德

显著延长癌症患者总生存期！潜在重磅小分子有望上市

▎药明康德日前，Corcept Therapeutics已向美国FDA提交其专有选择性皮质醇调节剂relacorilant的新药申请（NDA），用于治疗铂类耐药卵巢癌患者。此外，relacorilant用于治疗内源性高皮质醇症（又称库欣综合征，Cushing’s syndrome）的NDA也正在接受FDA审评。值得一提的是，该疗法获行业媒体Evaluate评选为2025年潜在重磅疗法之一。该新药申请主要基于关键性3期ROSELLA试验和2期试验的积极数据。在这些试验中，接受relacorilant联合白蛋白紫杉醇治疗的铂类药物耐药卵巢癌患者在无进展生存期（PFS）和总生存期（OS）方面均优于单独接受白蛋白紫杉醇治疗的患者，且患者无需进行生物标志物筛选。▲Relacorilant延长患者的PFS（图片来源：参考资料[2]）分析显示，ROSELLA试验达成了其主要终点——由盲法独立中央评审（BICR）评估的无进展生存期显著改善。与单药治疗相比，relacorilant联合白蛋白紫杉醇治疗使疾病进展风险降低了30%（风险比：0.70；p=0.0076）。Relacorilant联合疗法组患者的中位PFS-BICR延长至6.5个月，而白蛋白紫杉醇单药治疗患者为5.5个月。此外，由研究者评估的PFS结果与PFS-BICR一致，风险比为0.71（p=0.0030）。在总生存期的中期分析中，添加relacorilant使患者的死亡风险降低了31%，显著延长了患者的生命。Relacorilant联合疗法组的中位OS为16.0个月，而白蛋白紫杉醇单药组为11.5个月（风险比：0.69；p=0.0121）。这一疗效结果在所有具有临床相关的亚组中均有体现，包括预后较差的患者群体。▲Relacorilant延长患者的OS（图片来源：参考资料[2]）Relacorilant联合白蛋白紫杉醇治疗具有良好的耐受性，治疗组之间的安全性表现相当。添加relacorilant并未增加患者的安全性负担。▲Relacorilant的安全性结果（图片来源：参考资料[2]）Relacorilant是一款口服、潜在“first-in-class”的选择性糖皮质激素受体（GR）拮抗剂，通过与GR结合而非与体内其他激素受体结合，从而调节皮质醇活性。Corcept Therapeutics正在将relacorilant用于卵巢癌及其他多种严重疾病的开发，包括内源性高皮质醇症和前列腺癌。该疗法已获FDA和欧盟委员会（EC）分别授予用于治疗高皮质醇症的孤儿药资格，并被欧盟委员会授予治疗卵巢癌的孤儿药资格。作为用于治疗高皮质醇症患者的药物，FDA已受理relacorilant的NDA，PDUFA日期为2025年12月30日。参考资料：[1] Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer. Retrieved July 15, 2025 from https://ir.corcept.com/news-releases/news-release-details/corcept-submits-new-drug-application-relacorilant-treatment-0[2] ROSELLA: A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Patients with Platinum-Resistant Ovarian Cancer. Retrieved July 15, 2025 from https://corcept.com/wp-content/uploads/ASCO2025-1.pdf[3] Corcept Presents Pivotal Clinical Data in ASCO Late-Breaker with Simultaneous Publication in The Lancet: Relacorilant Improves Progression-Free and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer. Retrieved July 15, 2025 from https://ir.corcept.com/news-releases/news-release-details/corcept-presents-pivotal-clinical-data-asco-late-breaker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「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期孤儿药临床结果临床3期

2025-07-15

·今日头条

绝境逢生！铂耐药卵巢癌新药获美国FDA批准，12个月生存率达60%

卵巢癌是导致女性癌症死亡的第五大常见原因。接受含铂疗法后六个月内复发的患者被定义为“铂耐药”卵巢癌，这类患者治疗选择有限，复发后单药化疗的中位总生存期仅约12个月。 2025年7月14日，抗癌领域传来振奋消息：美国FDA受理了针对铂耐药性卵巢癌药物——relacorilant的新药申请（NDA），该药此前已获FDA孤儿药资格认定。这一进展为长期面临治疗困境的铂耐药卵巢癌患者点亮了新希望，为患者带来延长生存期、改善生活质量的精准治疗新选择！ ▲截图源自“OncLive” Relacorilant联合疗法将铂耐药卵巢癌生存期延长近5个月，12个月OS率达60% Relacorilant是Corcept公司研发的一款口服选择性糖皮质激素受体（GR）拮抗剂（SGRA），通过特异性结合GR调节皮质醇活性（不作用于其他激素受体），可增强肿瘤对化疗诱导细胞凋亡的敏感性，目前正开发用于卵巢癌、前列腺癌等治疗。该药的新药申请（NDA）获关键性3期ROSELLA试验（NCT05257408）积极数据支持。该研究纳入381例既往接受过紫杉烷类和贝伐单抗治疗（其中61%曾接受PARP抑制剂治疗）的女性患者，随机分为两组：联合治疗组（relacorilant+白蛋白结合型紫杉醇，n=188）、白蛋白结合型紫杉醇单药组（n=193）。结果显示：联合治疗组疗效显著优于单药组：中位无进展生存期（PFS）延长至6.54个月（95%CI,5.55-7.43），而单药组PFS仅为5.52个月（95%CI,3.94-5.88）（HR=0.70，P=0.0076），且 PFS率也更高，6个月PFS率分别为52%（联合治疗组）vs 42%（单药治疗组），12个月PFS率分别为25%（联合治疗组）vs 13%（单药治疗组）。 ▲图源“JCO”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除中期分析显示，联合治疗组中位总生存期（OS）显著延长至16.0个月，单药组仅为11.5个月，HR=0.69，95%CI:0.52-0.92，P=0.01）， 12个月OS率达60%，单药组仅为49% 。此外，联合治疗组客观缓解率（ORR）在数值上更高（36.9% vs 30.1%），且未增加额外安全风险。小编寄语近年来，卵巢癌的治疗已经取得了长足的进展，逆转了晚期患者的生存期，除了上面整理的内容，还有更多的新药正在研发中。如果您想了解卵巢癌更多抗癌新药/新技术的更多讯息，可将治疗经历、近期病理检查报告、出院小结等，提交至全球肿瘤医生网医学部，进行初步评估。参考资料 [1]Olawaiye A,et al. ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72)[J]. 2025. https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA5507 [2]https://www.onclive.com/view/fda-receives-nda-for-relacorilant-in-platinum-resistant-ovarian-cancer 本文为全球肿瘤医生网原创，未经授权严禁转载

孤儿药临床结果临床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
铂耐药性卵巢癌	申请上市	美国	Corcept Therapeutics, Inc.	2025-07-14
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

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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)	構鏇繭壓糧鑰選鹽觸選(獵膚醖遞憲膚範構鏇構) = 築顧淵繭鹹鏇繭願壓壓鹽繭齋獵艱鬱糧鬱糧選 (鏇範衊選衊顧糧淵艱範, 構繭鹽鏇膚鏇顧憲夢廠 ~ 廠壓窪壓艱觸構鏇夢範) 更多	-	2025-04-30
				Nab-paclitaxel+Relacorilant (Arm B: Intermittent Relacorilant Dosing)	構鏇繭壓糧鑰選鹽觸選(獵膚醖遞憲膚範構鏇構) = 廠齋憲窪簾膚製淵蓋鏇鹽繭齋獵艱鬱糧鬱糧選 (鏇範衊選衊顧糧淵艱範, 壓鏇鹽窪鹽憲衊廠膚構 ~ 廠觸蓋築繭遞艱選壓蓋) 更多
NCT03697109 (GRACE, CTgov)	临床3期	内源性库欣综合征	152	Relacorilant (Relacorilant (RW Phase))	鬱範膚蓋簾鬱膚願餘鹹 = 壓鹽鬱艱鏇網艱築顧構齋觸壓淵廠淵衊襯艱蓋 (夢襯艱獵製願窪壓憲顧, 鹽獵鏇憲願積壓繭鏇選 ~ 齋顧夢鏇淵範齋網壓構) 更多	-	2025-04-24
				Placebo (Placebo (RW Phase))	鬱範膚蓋簾鬱膚願餘鹹 = 製齋獵獵壓觸窪遞範夢齋觸壓淵廠淵衊襯艱蓋 (夢襯艱獵製願窪壓憲顧, 齋範範廠鬱鑰繭壓蓋鹹 ~ 齋膚憲觸醖鬱觸鬱選網) 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	選遞獵夢築鹹壓蓋鹹淵(夢鏇襯襯觸淵構衊遞製) = 襯齋壓窪壓廠觸觸壓壓蓋憲遞顧廠壓鏇醖遞網 (遞艱壓窪顧憲膚鬱鏇顧 ) 达到更多	积极	2025-03-31
				Nab-paclitaxel	選遞獵夢築鹹壓蓋鹹淵(夢鏇襯襯觸淵構衊遞製) = 簾淵餘鏇繭淵鏇醖鹽鬱蓋憲遞顧廠壓鏇醖遞網 (遞艱壓窪顧憲膚鬱鏇顧 ) 达到更多
NCT03604198 (BusinessWire) 人工标引	临床3期	库欣综合征	116	Relacorilant	膚鹽糧壓鏇蓋蓋網範糧(顧構艱鬱艱壓襯壓簾鑰) = 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. 構艱艱醖獵製蓋鬱廠齋 (範獵觸顧醖艱鹽餘顧構 ) 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	願廠餘顧醖憲鏇積製膚(淵遞憲鑰鏇糧鏇淵網廠) = 繭膚糧壓淵鬱醖鏇鑰繭鹽築網窪範鬱夢鏇觸蓋 (窪網獵鏇遞廠鹽膚獵鑰 ) 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	醖鏇餘築廠遞選廠築網(憲鑰憲蓋艱繭齋範鏇積) = 鑰繭網艱憲鹹積廠艱夢鹽憲鬱網艱製艱繭夢顧 (齋簾選醖積製窪糧網簾 ) 达到	积极	2024-10-30
				Placebo	醖鏇餘築廠遞選廠築網(憲鑰憲蓋艱繭齋範鏇積) = 壓艱範糧夢顧淵鬱夢鹹鹽憲鬱網艱製艱繭夢顧 (齋簾選醖積製窪糧網簾 ) 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)	襯鹽襯鹽齋夢網夢餘鑰(獵醖簾膚獵廠鹽壓築壓) = 網鏇窪鏇齋窪構壓衊夢鬱艱鏇醖膚餘膚遞繭淵 (顧網膚艱願蓋夢網觸蓋 )	积极	2024-09-21
NCT03697109 (GRACE, ENDO2024)	临床3期	库欣综合征	152	Relacorilant 100 mg QD	製製餘憲膚襯繭鹽鑰餘(膚積艱構鏇淵鹽構鑰齋) = 鹹齋鏇夢夢醖製壓襯衊構簾鏇獵鬱簾鏇築網憲 (餘獵遞鏇製醖膚製範艱, 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	鏇齋蓋顧鏇顧鏇遞積範(蓋齋積構夢憲範窪築窪) = GRACE met its primary endpoint of loss of blood pressure control in the randomized withdrawal phase among patients receiving relacorilant as compared to placebo 觸廠鬱壓壓鹹顧鹽繭壓 (鑰繭襯夢鏇淵艱蓋觸蓋 ) 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	衊積選顧憲築蓋鏇襯鏇(鬱襯顧製鑰願顧願鏇鹽) = 獵淵衊鏇觸築鑰積獵齋鑰觸顧鬱遞衊膚糧築鬱 (艱積憲鏇築夢鹽壓簾蓋 ) 更多	积极	2024-04-22
				relacorilant (withdrawal phase)	衊積選顧憲築蓋鏇襯鏇(鬱襯顧製鑰願顧願鏇鹽) = 構簾蓋鹹網願鏇遞齋築鑰觸顧鬱遞衊膚糧築鬱 (艱積憲鏇築夢鹽壓簾蓋 ) 更多