瑞卢戈利(Relugolix) - 药物靶点：GnRHR_在研适应症：晚期前列腺癌，去势敏感前列腺癌，子宫内膜异位症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Relugolix (JAN/USAN/INN)、瑞卢戈利、瑞格列克

+ [8]

靶点

GnRHR

作用方式

拮抗剂

作用机制

GnRHR拮抗剂(促性腺激素释放激素受体拮抗剂)

治疗领域

肿瘤泌尿生殖系统疾病

在研适应症

晚期前列腺癌去势敏感前列腺癌子宫内膜异位症+ [8]

非在研适应症

局限性前列腺癌月经过多疼痛

原研机构

Takeda Pharmaceutical Co., Ltd.

在研机构

Myovant Sciences GmbHAccord Healthcare SLU

ASKA Pharmaceutical Co., Ltd.

+ [5]

非在研机构

Takeda Pharmaceutical Co., Ltd.

Bushu Pharmaceuticals Ltd.

Millennium Pharmaceuticals, Inc.

最高研发阶段批准上市

首次获批日期

日本 (2019-01-08),

平滑肌瘤

最高研发阶段(中国)临床3期

特殊审评-

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结构/序列

分子式C29H27F2N7O5S

InChIKeyAOMXMOCNKJTRQP-UHFFFAOYSA-N

CAS号737789-87-6

关联

88

项与瑞卢戈利相关的临床试验

CTRI/2024/07/070478

/ CompletedN/A

An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Crossover Truncated Four Period Fully Replicate Reference Scaled Average Oral Bioequivalence Study Comparing Relugolix 120 mg Tablets Manufactured By BDR Pharmaceuticals Internationals Pvt Ltd India With Orgovyx (Relugolix) 120 MG Tablets Distributed By Sumitomo Pharma America Inc In Healthy Adult Human Male Subjects Under Fed Conditions - NIL

开始日期2025-07-01

申办/合作机构

BDR Pharmaceuticals International Pvt Ltd.

CTR20244923

/ Recruiting临床3期

一项在激素敏感性晚期前列腺癌患者中评估QLG1080（瑞卢戈利片）有效性和安全性的多中心研究

主要研究目的：以血清睾酮持续去势率为主要评价指标，评价QLG1080（瑞卢戈利片）治疗激素敏感性晚期前列腺癌的有效性。次要研究目的：评价QLG1080（瑞卢戈利片）治疗激素敏感性晚期前列腺癌患者的安全性及其他疗效指标。

开始日期2025-02-24

申办/合作机构

齐鲁制药有限公司

NCT06837896

/ Not yet recruiting临床3期

A Multicenter Study Evaluating the Efficacy and Safety of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer

The purpose of this study was to evaluate the efficacy and safety of QLG1080 in patients with hormone-sensitive advanced prostate cancer.

开始日期2025-02-01

申办/合作机构

齐鲁制药有限公司

100 项与瑞卢戈利相关的临床结果

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100 项与瑞卢戈利相关的转化医学

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100 项与瑞卢戈利相关的专利（医药）

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218

项与瑞卢戈利相关的文献（医药）

2025-06-01·JOURNAL OF MOLECULAR STRUCTURE

Screening, preparation, structural characterization, evaluation and solubility prediction of relugolix complexes with heterocyclic co-formers

作者: Li, Gang ; Zhu, Xue-yan ; Liu, Xiang-kui ; Tian, Guang-xin ; Luo, Ying ; Hu, Liang ; Chen, Yin-bo ; Shen, Yu-hui ; Yu, Xi-hua ; Wang, Qiang ; Lu, Wei-gen

Co-crystallization has received widespread attention, particularly in the modification of poorly water-soluble drugs.In this paper, two new complexes were obtained from heterocyclic co-formers, namely relugolix-pyrazine and relugolix-2-picolinic acid.Relugolix-pyrazine was identified as a cocrystal, while relugolix-2-picolinic acid was identified as a salt based on single crystal anal.The introduction of co-former induced a conformational alteration in relugolix to some degree and stabilized the structure through weak intermol. forces.Relugolix-pyrazine exhibited improved solubility, stability and drug-target interactions, effectively addressing the limitations of the parent mol. regarding its physicochem. properties.Addnl., we developed computational simulations to predict the solubility and proposed a method to predict unknown substances which include cocrystals and salts.The simulations aimed to elucidate the dissolution behavior of these substances, and the results were consistent with the exptl. data, thereby demonstrating that the formation of cocrystals/salts is thermodynamically favorable for their dissolution

2025-04-21·Future Oncology

Study of persistence and adherence to ADT in prostate cancer: relugolix, degarelix, and GnRH agonists in the US

Article

作者: Flanders, Scott C. ; Kinkead, Frédéric ; Romdhani, Hela ; Ryan, Michael J. ; Hafron, Jason ; McKay, Rana R. ; Hong, Agnes

AIMS:

Androgen deprivation therapy (ADT) is standard for advanced prostate cancer. Relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, is the only oral ADT, with limited real-world data on therapy persistence and adherence. This retrospective study evaluates persistence and adherence of relugolix, degarelix, and GnRH agonists (leuprolide, goserelin, triptorelin, histrelin) using data from the IBM MarketScan Research Database (Jan 2017 - Dec 2022).

METHODS:

The IBM MarketScan Research Database (1 January 2017 - 31 December 2022) was used for enrollment history and claims. ADT adherence was measured by the proportion of days covered (PDC) at 3, 6, and 12 months, calculated as days on ADT divided by period duration. Kaplan-Meier analysis assessed treatment persistence by measuring time to treatment discontinuation.

RESULTS:

Relugolix had higher adherence (PDC ≥ 80%) at 12 months (60.8%) compared to degarelix (13.0%) and GnRH agonists (46.3%). Median time to discontinuation was also longer for relugolix (13.5 months) than degarelix (3.1 months) and GnRH agonists (8.8 months). Persistence and adherence rates were higher in metastatic prostate cancer.

CONCLUSIONS:

Findings support relugolix use as an oral treatment due to its favorable persistence and long-term adherence profiles.

2025-03-28·Future Oncology

The impact of concomitant therapies on the efficacy and safety of relugolix in advanced prostate cancer

Review

作者: Shore, Neal D. ; Spratt, Daniel E. ; De La Cerda, Jose ; George, Daniel J.

Relugolix is a once-daily oral gonadotropin-releasing hormone antagonist that was approved by the U.S. Food and Drug Administration in 2020 for the treatment of advanced prostate cancer. Relugolix is commonly co-prescribed with complementary oncologic therapies or agents targeting associated comorbidities (e.g. cardiovascular disease). In this podcast, we review studies which evaluate relugolix with concomitant next-generation hormonal therapies (abiraterone, apalutamide, and enzalutamide), chemotherapy (docetaxel), radiotherapy, and common cardiovascular medications (antihypertensives, antithrombotics, and lipid‑lowering agents). Based on these studies, these therapies do not appear to affect relugolix efficacy and no new safety concerns were reported.

136

项与瑞卢戈利相关的新闻（医药）

2025-04-13

·信狐药迅

恒瑞医药-夫那奇珠单抗注射液银屑病新适应症获批上市| 新获批(4.7-4.13）

每周药品注册获批数据，分门别类呈现，一目了然。(4.7-4.13）新药上市申请药品名称企业注册分类受理号SHR0302片江苏恒瑞医药股份有限公司1CXHS2300097夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司1CXSS2400018夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司1CXSS2400017新药临床申请药品名称企业注册分类受理号注射用BH259珠海贝海生物技术有限公司1CXHL2500168HRS9531注射液福建盛迪医药有限公司1CXHL2500157HRS9531注射液福建盛迪医药有限公司1CXHL2500156HRS9531注射液福建盛迪医药有限公司1CXHL2500155HRS-9813胶囊广东恒瑞医药有限公司1CXHL2500147TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2500137TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2500136AC699片冰洲石生物科技(上海)有限公司1CXHL2500145AC699片冰洲石生物科技(上海)有限公司1CXHL2500142TQB3019胶囊正大天晴药业集团股份有限公司1CXHL2500138TT-9701片中国科学院上海药物研究所1CXHL2500129TT-9701片中国科学院上海药物研究所1CXHL2500128INR102注射液云核医药(天津)有限公司1CXHL2500121FY101注射液北京福元医药股份有限公司1CXHL2500100DNV001注射液杭州鼎乐新为生物科技有限公司1CXHL2500095奥格特韦钠胶囊浙江艾森药业有限公司1CXHL2500093SYH2046片上海翊石医药科技有限公司1CXHL2500091SYH2046片上海翊石医药科技有限公司1CXHL2500090RN1871 注射液大睿生物医药科技(上海)有限公司1CXHL2500078注射用IMBZ18g广州艾奇西新药研究有限公司1CXHL2500053DM2065贴北京德默高科医药技术有限公司2.2CXHL2500148司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500127司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500126司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500125司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500124LH-2103胶囊江苏联环药业股份有限公司2.3CXHL2500114注射用西罗莫司(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500134带状疱疹mRNA疫苗上海生物制品研究所有限责任公司1.2CXSL2500040AK139注射液中山康方生物医药有限公司1CXSL2500100AK139注射液中山康方生物医药有限公司1CXSL2500099BNT327百欧恩泰(上海)医药有限公司1CXSL2500096BNT326百欧恩泰(上海)医药有限公司1CXSL2500095注射用SIM0686上海先祥医药科技有限公司1CXSL2500097注射用QLS31905齐鲁制药有限公司1CXSL2500084ADG126注射液天演药业(苏州)有限公司1CXSL2500089注射用ZG005苏州泽璟生物制药股份有限公司1CXSL2500083注射用ASKG915江苏奥赛康生物医药有限公司1CXSL2500092SHR-1819注射液广东恒瑞医药有限公司1CXSL2500086SHR-4658注射液上海恒瑞医药有限公司1CXSL2500067EA5注射液上海览屹医药科技有限公司1CXSL2500051P134细胞注射液天士力医药集团股份有限公司1CXSL2500032XS411细胞注射液士泽生物医药(苏州)有限公司1CXSL2500035卡度尼利单抗注射液康方药业有限公司2.2CXSL2500102QL2107注射液齐鲁制药有限公司2.2CXSL2500085SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500088阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500093阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500081纳基奥仑赛注射液广东合源生物医药有限公司2.2CXSL2500030仿制药申请药品名称企业注册分类受理号法莫替丁注射液广州一品红制药有限公司3CYHS2401785盐酸纳美芬注射液福建新迪医药科技有限公司3CYHS2401361帕拉米韦注射液山东齐都药业有限公司3CYHS2400400氯化钾注射液福建新迪医药科技有限公司3CYHS2303635盐酸阿比多尔片武汉人福利康药业有限公司3CYHS2303169普瑞巴林口服溶液浙江浙北药业有限公司3CYHS2302826钠钾镁钙注射用浓溶液南京正科医药股份有限公司3CYHS2302809普瑞巴林口服溶液广西维威制药有限公司3CYHS2302626磷酸奥司他韦干混悬剂江苏加友药业集团有限公司3CYHS2302613生理氯化钠溶液山东科伦药业有限公司3CYHS2302543生理氯化钠溶液山东科伦药业有限公司3CYHS2302542福多司坦口服溶液昆明南疆制药有限公司3CYHS2302476复方匹可硫酸钠颗粒江西科睿药业有限公司3CYHS2302428氨茶碱注射液华夏生生药业(北京)有限公司3CYHS2302129昂丹司琼口溶膜江苏和晨药业有限公司3CYHS2302092昂丹司琼口溶膜江苏和晨药业有限公司3CYHS2302091依巴斯汀口服溶液海南元盈医药科技有限公司3CYHS2302066熊去氧胆酸口服混悬液成都赛璟生物医药科技有限公司3CYHS2302006洛索洛芬钠口服溶液云南先施药业有限公司3CYHS2301966氢溴酸依他佐辛注射液合肥亿帆生物制药有限公司3CYHS2301841复方聚乙二醇(3350)电解质散南京同仁堂黄山精制药业有限公司3CYHS2301730奥硝唑注射液海南海灵化学制药有限公司3CYHS2301608注射用苯唑西林钠广东金城金素制药有限公司3CYHS2301449注射用苯唑西林钠广东金城金素制药有限公司3CYHS2301448米诺地尔外用溶液江苏润邦药业有限公司3CYHS2301430米诺地尔外用溶液江苏润邦药业有限公司3CYHS2301429右酮洛芬氨丁三醇片湖南诺纳医药科技有限公司3CYHS2301107盐酸左西替利嗪口服溶液吉林省辉南长龙生化药业股份有限公司3CYHS2300981聚乙烯醇滴眼液浙江莎普爱思药业股份有限公司3CYHS2300976维生素K滴剂广西铭磊维生制药有限公司3CYHS2201025国;CYHS2201025复方氨基酸注射液(18AA-IX)辽宁民康制药有限公司4CYHS2500159沙美特罗替卡松吸入粉雾剂润生药业有限公司4CYHS2403268硫酸氢氯吡格雷片四川鲁徽制药有限责任公司4CYHS2400549西洛他唑片烟台万润药业有限公司4CYHS2400480硫酸氨基葡萄糖胶囊广州汇元医药科技有限公司4CYHS2400433达格列净片江苏万高药业股份有限公司4CYHS2400293达格列净片江苏万高药业股份有限公司4CYHS2400292甲磺酸多沙唑嗪缓释片四川科伦药业股份有限公司4CYHS2400244地夸磷索钠滴眼液武汉五景药业有限公司4CYHS2400230吸入用丙酸倍氯米松混悬液江西艾施特制药有限公司4CYHS2400132达格列净片福元药业有限公司4CYHS2303637达格列净片福元药业有限公司4CYHS2303636黄体酮软胶囊浙江神洲药业有限公司4CYHS2303548二甲双胍恩格列净片(VI)山东朗诺制药有限公司4CYHS2303456二甲双胍恩格列净片(I)山东朗诺制药有限公司4CYHS2303455注射用头孢他啶阿维巴坦钠成都倍特药业股份有限公司4CYHS2303429注射用替考拉宁福安药业集团烟台只楚药业有限公司4CYHS2303391注射用盐酸万古霉素海南倍特药业有限公司4CYHS2303276枸橼酸西地那非片遂成药业股份有限公司4CYHS2303272枸橼酸西地那非片遂成药业股份有限公司4CYHS2303271氧(液态)南宁市卓越气体有限公司4CYHS2303098复方氨基酸注射液(18AA-VII)山东齐都药业有限公司4CYHS2303086盐酸屈他维林注射液北京沃邦医药科技有限公司4CYHS2303060培哚普利叔丁胺片安若维他药业泰州有限公司4CYHS2302967培哚普利叔丁胺片安若维他药业泰州有限公司4CYHS2302966培哚普利叔丁胺片安若维他药业泰州有限公司4CYHS2302965盐酸贝尼地平片四川科瑞德制药股份有限公司4CYHS2302931长链脂肪乳注射液(OO)广东嘉博制药有限公司4CYHS2302821利丙双卡因乳膏浙江沣华医药科技有限公司4CYHS2302779乳果糖口服溶液哈药集团中药二厂4CYHS2302709缬沙坦氨氯地平片(I)河北万岁药业有限公司4CYHS2302651甲磺酸倍他司汀片厦门恩成制药有限公司4CYHS2302477左卡尼汀口服溶液东药集团沈阳施德药业有限公司4CYHS2302431骨化三醇软胶囊广州艾格生物科技有限公司4CYHS2302406沙库巴曲缬沙坦钠片沐邦(北京)医药科技有限公司4CYHS2302076沙库巴曲缬沙坦钠片沐邦(北京)医药科技有限公司4CYHS2302075沙库巴曲缬沙坦钠片沐邦(北京)医药科技有限公司4CYHS2302074头孢地尼颗粒重庆吉斯瑞制药有限责任公司4CYHS2302029硝酸甘油喷雾剂北京双鹭药业股份有限公司4CYHS2301947二甲双胍恩格列净片(I)杭州朱养心药业有限公司4CYHS2301801甲磺酸溴隐亭片浙江泰利森药业有限公司4CYHS2301125进口申请药品名称企业注册分类受理号盐酸伊普可泮胶囊Novartis Pharma Schweiz AG2.4JXHS2400061环索奈德吸入气雾剂Covis Pharma GmbH5.1JXHS2400019环索奈德吸入气雾剂Covis Pharma GmbH5.1JXHS2400018枸橼酸艾瑞芬净片SCYNEXIS, Inc.5.1JXHS2300072地诺孕素片Laboratoires Besins International5.2JYHS2400030注射用厄他培南Savior Lifetec Corporation5.2JYHS2300070布地奈德福莫特罗吸入气雾剂Mylan Pharmaceuticals Inc.5.2JYHS2300039布地奈德福莫特罗吸入气雾剂Mylan Pharmaceuticals Inc.5.2JYHS2300038MT-7117 片Mitsubishi Tanabe Pharma Corporation1JXHL2500014PF-07275315注射液Pfizer Inc.1JXSL2500035度伐利尤单抗注射液MedImmune LLC2.2JXSL2500018艾氟洛芬贴剂齐鲁制药有限公司3CYHL2500032氟比洛芬贴剂江西康恩贝中药有限公司3CYHL2500030双氯芬酸钠贴剂深圳珐玛易药品科技有限公司3CYHL2500027帕立骨化醇软胶囊青岛国信制药有限公司3CYHL2500029帕立骨化醇软胶囊青岛国信制药有限公司3CYHL2500028无水甜菜碱散剂伊春五加参药业有限责任公司3CYHL2500026瑞卢戈利片浙江和泽医药科技股份有限公司3CYHL2500017阿瑞匹坦注射液山东齐都药业有限公司3CYHL2500016尿素[13C]呼气试验药盒辐瑞森生物科技(昆山)有限公司3CYHL2500015尿素[13C]呼气试验药盒辐瑞森生物科技(昆山)有限公司3CYHL2500014甘露醇山梨醇注射液湖南先施制药有限公司3CYHL2500008皮下注射人免疫球蛋白华润博雅生物制药集团股份有限公司3.2CXSL2500031中药相关申请无注：橙色字体部分结论为不批准或收到通知件；

疫苗信使RNA申请上市上市批准临床申请

2025-03-13

·Pharmaceutical Technology

Gedeon Richter’s once-daily endometriosis pill approved for NHS use

Endometriosis can cause severe pain, heavy periods, fatigue, and fertility issues. Credit: LaylaBird via Getty Images. The UK’s National Institute for Health and Care (NICE) has approved Gedeon Richter’s Ryeqo (relugolix–estradiol–norethisterone), a once-daily oral treatment for endometriosis, for use on the National Health Service (NHS). The drug works by blocking gonadotrophin releasing hormone (GnRH) that contributes to endometriosis while simultaneously providing necessary hormone replacement. Unlike traditional GnRH agonists – such as Takeda’s Prostap (leuprorelin) and AstraZeneca’s Zoladex (goserelin) – which are limited to six months of use, Ryeqo can be taken until menopause. NICE estimates that around 1,000 women per year could benefit from the treatment, which has a list price of £72 per 28-day pack. Helen Knight, director of medicines evaluation at NICE, highlighted the benefits of a pill-based treatment: “Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home. The treatment can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side effects.” Endometriosis, a condition where tissue similar to the womb lining grows outside the uterus, causes severe pain, heavy periods, fatigue and fertility issues. Current treatment options include pain relief, hormonal therapy, and surgery. Ryeqo is now an option for those who have previously undergone medical or surgical treatments but found alternatives like tranexamic acid, hormonal contraceptives, and intrauterine delivery systems ineffective or unsuitable. NICE’s final draft guidance emphasised the need for non-invasive, long-term treatment options for endometriosis symptoms, as there is no cure. Charities, including Endometriosis UK, welcomed the news, but noted that Ryeqo induces a state of “medical menopause” alongside hormone replacement therapy (HRT), meaning it may only be suitable for “a small proportion of the 1.5 million with the disease”. NICE reversed its previous negative stance on the drug after Gedeon Richter provided additional evidence on the drug’s effectiveness and cost-effectiveness. Ryeqo improved endometriosis-associated pain and was well tolerated compared to placebo in the Phase III SPIRIT 1 (NCT03204318) and SPIRIT 2 (NCT03204331) clinical studies, which enrolled over 1,200 women. Beyond the approval of new treatments, Endometriosis UK has called for greater investment in research to find the root cause of the disease, improve management strategies, and to develop a cure. At the Royal Society of Medicine’s Innovation in Women’s Health and Femtech meeting on 3 March 2025, McKinsey partner Anouk Petersen pointed out that despite affecting a similar proportion of the population as diabetes (about 10%), endometriosis receives eight to ten times less funding. A report from McKinsey & Company and the World Economic Forum underscored the economic impact of conditions like endometriosis, finding that while women live longer than men, they spend 25% more of their lives in debilitating health conditions. This has direct productivity consequences, with 60% of the gender health gap occurring during prime working years, contributing to 80% of the economic burden on gross domestic product (GDP). According to GlobalData’s Pharma Intelligence Center, Ryeqo is forecast to generate up to $775m in sales in 2030. GlobalData is the parent company of Pharmaceutical Technology.

临床结果上市批准临床3期

2025-03-13

·PMLiVE

NICE recommends Gideon Richter’s Ryeqo as first daily pill for endometriosis

The National Institute for Health and Care Excellence (NICE) has recommended Gideon Richter’s Ryeqo (relugolix, estradiol and norethisterone) as the first long-term daily pill for endometriosis. NICE has recommended in final draft guidance that the relugolix combination therapy be used on the NHS in England to treat the symptoms of endometriosis in adults of reproductive age who have had medical or surgical treatment for the chronic condition. The health technology assessment agency’s decision follows an earlier negative recommendation and comes after Gideon provided new evidence on the Ryeqo’s effectiveness and value for money. Affecting approximately 1.5 million women in the UK, endometriosis occurs when tissue similar to the lining of the uterus grows elsewhere in the body. Patients can experience a range of symptoms, including dysmenorrhoea (painful cramping, usually in the lower abdomen), heavy bleeding and pelvic pain. Ryeqo is designed to block the specific hormones that contribute to endometriosis while also providing necessary hormone replacement in a single daily tablet. NICE estimates that around 1,000 patients per year could benefit from the therapy. Helen Knight, director of medicines evaluation at NICE, said Ryeqo “marks a potential step-change in how we manage endometriosis”. She continued: “Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home. The treatment can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side effects.” Among the clinical evidence supporting NICE’s recommendation were positive results from the late-stage SPIRIT programme, in which significantly more patients achieved pain reduction with Ryeqo versus placebo at 24 weeks. In the SPIRIT 1 study, 75% of patients responded to Ryeqo for their dysmenorrhoea compared to 27% in the placebo arm. The same result was seen in SPIRIT 2, with 75% of dysmenorrhoea responders in the Ryeqo cohort compared to 30% for placebo. Additionally, 59% and 66% of patients responded to Ryeqo for their non-menstrual pelvic pain (NMPP) in SPIRIT 1 and 2, respectively, compared to 40% and 43% of those receiving placebo. Positive long-term efficacy data from the SPIRIT open-label extension study, which showed that dysmenorrhoea and NMPP reduction was sustained over two years with Ryeqo treatment, also supported the agency’s decision.

临床结果上市批准

100 项与瑞卢戈利相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D10888	瑞卢戈利	L01XX	DB11853

研发状态

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适应症	国家/地区	公司	日期
晚期前列腺癌	加拿大	Sumitomo Pharma Co., Ltd.	2023-10-10
去势敏感前列腺癌	欧盟	Accord Healthcare SLU	2022-04-29
去势敏感前列腺癌	冰岛	Accord Healthcare SLU	2022-04-29
去势敏感前列腺癌	列支敦士登	Accord Healthcare SLU	2022-04-29
去势敏感前列腺癌	挪威	Accord Healthcare SLU	2022-04-29
子宫内膜异位症	日本	ASKA Pharmaceutical Co., Ltd.	2021-12-24
前列腺癌	美国	Sumitomo Pharma Co., Ltd.	2020-12-18
平滑肌瘤	日本	ASKA Pharmaceutical Co., Ltd.	2019-01-08

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适应症	最高研发状态	国家/地区	公司	日期
复发性前列腺癌	临床3期	美国	Sumitomo Pharma America, Inc.	2025-01-31
复发性前列腺癌	临床3期	美国	Pfizer Inc.	2025-01-31
月经过多	临床3期	美国	Myovant Sciences GmbH	2017-04-26
月经过多	临床3期	巴西	Myovant Sciences GmbH	2017-04-26
月经过多	临床3期	意大利	Myovant Sciences GmbH	2017-04-26
月经过多	临床3期	波兰	Myovant Sciences GmbH	2017-04-26
月经过多	临床3期	南非	Myovant Sciences GmbH	2017-04-26
月经过多	临床3期	英国	Myovant Sciences GmbH	2017-04-26
子宫肌瘤	临床3期	美国	Myovant Sciences GmbH	2017-04-26
子宫肌瘤	临床3期	巴西	Myovant Sciences GmbH	2017-04-26

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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


NCT04666129 (ASCO_GU2025) 人工标引	临床1期	晚期前列腺癌	24	Relugolix 120 mg + Abiraterone 1000 mg + prednisone 5 mg/methylprednisolone 4 mg (Part 1)	憲獵壓憲壓糧鹽艱範鹽(網範餘選醖網齋網艱築) = 壓醖糧衊艱獵衊餘簾膚簾鑰廠鑰觸壓繭膚築觸 (積網壓廠顧選遞襯憲鏇, 3.2) 更多	积极	2025-02-13
				Relugolix 240 mg + Apalutamide 240 mg	憲獵壓憲壓糧鹽艱範鹽(網範餘選醖網齋網艱築) = 鏇積糧壓憲鹽鏇簾淵淵簾鑰廠鑰觸壓繭膚築觸 (積網壓廠顧選遞襯憲鏇, 8.0) 更多
ASCO_GU2025	N/A	-	5,274	relugolix (Nonmetastatic Prostate Cancer (nmPC))	醖簾鹽醖繭餘蓋餘觸網(鏇簾築窪廠窪醖鹹鬱淵) = 製築齋鏇簾觸鹽襯獵獵襯鏇簾鏇衊壓構鑰鹽膚 (製鹹製窪鹹糧蓋製鬱襯, ±10 [99]) 更多	-	2025-02-13
				relugolix (Metastatic Prostate Cancer (mPC))	醖簾鹽醖繭餘蓋餘觸網(鏇簾築窪廠窪醖鹹鬱淵) = 築選壓壓醖襯壓壓顧齋襯鏇簾鏇衊壓構鑰鹽膚 (製鹹製窪鹹糧蓋製鬱襯, ±10 [99]) 更多
NCT03751124 (CTgov)	临床3期	月经过多 \| 子宫肌瘤	229	Relugolix+E2/NETA (Relugolix Plus E2/NETA (Group A))	餘鏇餘窪鬱鏇廠範膚齋 = 範簾醖窪鑰鏇願構艱憲夢蓋齋壓鹹憲製鏇淵簾 (積艱襯廠築鑰製廠壓願, 夢鹽積遞製遞淵憲獵獵 ~ 艱選獵淵製願簾簾觸齋) 更多	-	2024-06-25
				Placebo (Placebo (Group B))	餘鏇餘窪鬱鏇廠範膚齋 = 襯壓簾鹽蓋範艱糧製醖夢蓋齋壓鹹憲製鏇淵簾 (積艱襯廠築鑰製廠壓願, 淵齋壓膚壓蓋顧膚構範 ~ 鏇獵選艱簾鑰構築鏇遞) 更多
NCT05467176 (OPTYX study, ASCO2024)	N/A	Usher综合征 PSA \| testosterone \| distant metastases	394	Relugolix monotherapy	廠製艱築顧餘窪夢蓋夢(餘顧齋顧膚獵襯鏇憲獵) = 構觸構積淵觸簾築積廠範鏇襯顧襯憲窪蓋繭積 (淵醖範遞製選齋網淵繭, 238.5) 更多	-	2024-05-24
ASCO2024	N/A	-	267	Relugolix	衊積醖鏇窪構鏇選窪繭(餘範衊構觸製壓鹹繭繭) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment 襯蓋淵繭範積觸醖糧衊 (遞憲醖膚選鏇餘鏇蓋艱 )	-	2024-05-24
NCT03412890 (CTgov)	临床3期	月经过多 \| 子宫肌瘤	477	Relugolix+E2/NETA (Relugolix Plus E2/NETA (Group A))	簾廠網鬱選夢壓淵願鏇 = 製醖齋範膚膚製膚鏇鹽鹽糧齋糧襯鏇鹹艱淵衊 (選製淵觸齋範廠醖遞繭, 憲繭積夢齋範艱鏇顧齋 ~ 齋願餘夢獵鹽製願鹽艱) 更多	-	2024-05-09
				Relugolix+E2/NETA (Relugolix Plus Delayed E2/NETA (Group B))	簾廠網鬱選夢壓淵願鏇 = 淵鹽顧窪構構壓鑰鹹襯鹽糧齋糧襯鏇鹹艱淵衊 (選製淵觸齋範廠醖遞繭, 選糧製積繭觸醖廠鏇繭 ~ 鹽衊廠築鏇蓋廠壓膚顧) 更多
AUA2024	N/A	晚期前列腺癌	-	Leuprolide	糧糧遞醖夢鹽廠餘窪構(艱構蓋鹽鹹夢繭淵艱網) = 鏇積網積願觸夢襯構鏇積齋顧夢夢觸築製蓋淵 (襯鏇繭襯膚築淵構艱顧 )	-	2024-05-01
				Relugolix	糧糧遞醖夢鹽廠餘窪構(艱構蓋鹽鹹夢繭淵艱網) = 網繭鏇願築選範餘顧選積齋顧夢夢觸築製蓋淵 (襯鏇繭襯膚築淵構艱顧 )
NCT03103087 \| NCT03049735 \| NCT03412890 (Pubmed \| Am J Obstet Gynecol)	临床3期	子宫肌瘤	-	Relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg)	蓋網繭憲鑰鬱製蓋餘遞(選蓋衊願構積憲鬱憲觸) = 5.7% 膚構夢憲齋膚艱膚鑰膚 (鏇製顧築壓鑰鹹齋憲製 ) 更多	-	2024-02-01
NCT03085095 (HERO, ASCO_GU2024) 人工标引	临床3期	前列腺癌	25	Relugolix	艱鬱襯淵齋範齋鬱鏇願(鹹鬱鑰遞構鏇願獵齋襯) = 襯願範觸齋鬱鬱淵網願壓蓋遞齋窪鬱遞齋膚獵 (積憲衊蓋鹹膚淵鑰糧憲, 0.67 ~ 2.5) 更多	积极	2024-01-25
HERO study (ASCO_GU2024)	N/A	晚期前列腺癌	152	Relugolix	膚遞築簾齋顧醖糧淵蓋(醖範蓋構壓範憲齋蓋獵) = Three pts (2%) had a major adverse cardiovascular event, including one sudden death, one with congestive heart failure, and one with myocardial infarction. Two pts (1%) reported grade 3 fatigue. G3 LFT elevations recorded in 2 pts (1%). No clinical signals of DDI reported. 窪鏇遞製糧憲顧遞廠鬱 (鬱顧獵艱構繭憲鑰鏇遞 )	积极	2024-01-25