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

登录后查看更多信息

100 项与瑞卢戈利相关的转化医学

登录后查看更多信息

100 项与瑞卢戈利相关的专利（医药）

登录后查看更多信息

213

项与瑞卢戈利相关的文献（医药）

2025-03-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Repurposing FDA-approved drugs to target G-quadruplexes in breast cancer

Article

作者: Moraca, Federica ; Napolitano, Fabiana ; D'Aria, Federica ; Pagano, Bruno ; Amato, Jussara ; Catalanotti, Bruno ; Di Porzio, Anna ; Castellano, Giuliano ; Landolfi, Laura ; Malfitano, Anna Maria ; Arciuolo, Valentina ; Marzano, Simona ; Randazzo, Antonio

Breast cancer, a leading cause of cancer-related mortality in women, is characterized by genomic instability and aberrant gene expression, often influenced by noncanonical nucleic acid structures such as G-quadruplexes (G4s). These structures, commonly found in the promoter regions and 5'-untranslated RNA sequences of several oncogenes, play crucial roles in regulating transcription and translation. Stabilizing these G4 structures offers a promising therapeutic strategy for targeting key oncogenic pathways. In this study, we employed a drug repurposing approach to identify FDA-approved drugs capable of binding and stabilizing G4s in breast cancer-related genes. Using ligand-based virtual screening and biophysical methods, we identified several promising compounds, such as azelastine, belotecan, and irinotecan, as effective G4 binders, with significant antiproliferative effects in breast cancer cell lines. Notably, belotecan and irinotecan exhibited a synergistic mechanism, combining G4 stabilization with their established topoisomerase I inhibition activity to enhance cytotoxicity in cancer cells. Our findings support the therapeutic potential of G4 stabilization in breast cancer, validate drug repurposing as an efficient strategy to identify G4-targeting drugs, and highlight how combining G4 stabilization with other established drug activities may improve anticancer efficacy.

2025-03-01·FERTILITY AND STERILITY

Inhibition of ovulation and pharmacologic mechanism of action of relugolix combination therapy

Article

作者: Klipping, C ; Migoya, E M ; Arjona Ferreira, J C ; Li, Y ; Wedemeyer, R-S ; Schug, B S ; Draeger, C ; Duijkers, I J M

OBJECTIVE:

To assess the effects of relugolix combination therapy on ovarian function in healthy, ovulatory, premenopausal women.

DESIGN:

This was an open-label, single-cohort, pharmacodynamic, safety and tolerability study consisting of five study periods: a Pre-Treatment Period to confirm ovulatory status, three 28-day treatment periods, and a Post-Treatment Period to assess duration of time required to return to ovulation following treatment discontinuation. Ovarian function was assessed by transvaginal ultrasonography and serum hormone concentrations.

SUBJECTS:

Healthy, premenopausal female participants, 18-35 years of age.

INTERVENTION/EXPOSURE:

Relugolix combination therapy (relugolix 40 mg, with estradiol 1 mg and norethindrone acetate 0.5 mg) was taken orally once daily for 84 days.

MAIN OUTCOME MEASURES:

The primary endpoint was the proportion of women in whom ovulation was inhibited during the entire 84-day treatment period. Secondary endpoints included proportion of women in whom ovulation was inhibited within each treatment period, number of women who fulfilled the Landgren criterion; characterization of follicular diameter, hormone concentrations, and endometrial thickness; time to return to ovulation following treatment discontinuation; proportion of women who returned to ovulation within 36 days following treatment discontinuation; safety and tolerability.

RESULTS:

Seventy women were enrolled in the study, 67 of whom completed treatment. Treatment with relugolix combination therapy inhibited ovulation in 100% of women who completed treatment (95% confidence interval: 94.6, 100.0). Systemic concentrations of luteinizing hormone and follicle-stimulating hormone were suppressed and maintained at low concentrations during treatment, with an absence of a preovulatory luteinizing hormone surge. Median estradiol concentrations across all women were consistently maintained between 36.8 and 39.1 pg/mL (range: 12.1-121.1 pg/mL) during treatment. All individual progesterone concentrations during treatment remained below 1.57 ng/mL (5 nmol/L). Following treatment discontinuation, all women ovulated or initiated menses. The mean time to return to ovulation was 23.5 days. Treatment was generally well tolerated with no safety or tolerability issues identified.

CONCLUSION:

Relugolix combination therapy inhibits ovulation, which, in the context of this study, was achieved within the first cycle following treatment initiation. The rapid and predictable return of ovarian activity and ovulation following treatment discontinuation is advantageous for patients who wish to conceive thereafter.

2025-02-01·Pharmacology Research & Perspectives

Transfer of the Oral Gonadotropin‐Releasing Hormone Receptor Antagonist Relugolix Into Breast Milk of Healthy Lactating Women

Article

作者: Lee, Sarah ; Brimhall, Darin B. ; Yoshida, Kazumasa ; Chen, Yu‐Luan ; Ufer, Mike

ABSTRACT:

Relugolix is an oral gonadotropin‐releasing hormone receptor antagonist that suppresses sex steroid hormones and is approved as monotherapy for prostate cancer and as a fixed‐dose combination with estradiol/norethindrone for the treatment of endometriosis and uterine fibroids. The aim of this postmarketing study was to determine the pharmacokinetics and quantify the amount of relugolix excreted into breast milk of healthy lactating women. Following a single, oral dose of 40 mg relugolix, breast milk was sampled over 120 h. Pharmacokinetic parameters were determined, including the cumulative amount of relugolix excreted into breast milk to derive the total infant dose. The safety and tolerability of relugolix were also assessed. Eight healthy lactating women were enrolled and completed the study per protocol. Relugolix was safe and well tolerated based on adverse events and other safety data. It was excreted into breast milk with a median time to peak concentration (tmax) of 5.81 h and a geometric mean peak concentration (Cmax) of 15.7 ng/mL, similar to corresponding plasma data from previous clinical studies. The mean cumulative amount of relugolix excreted was 0.0051 mg over 24 h and 0.0067 mg over 120 h, corresponding to 0.0128% and 0.0167% of the maternal dose, respectively. The body weight‐adjusted relative daily infant dose of approximately 0.25% suggests a 400‐fold lower newborn than maternal relugolix exposure. Relevant effects of relugolix on the breastfed child appear unlikely given its limited excretion into breast milk of lactating women but cannot be fully excluded in the absence of infant safety data.

135

项与瑞卢戈利相关的新闻（医药）

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

2025-03-09

·信狐药迅

乐普ADC重磅产品注射用维贝柯妥塔单抗主动撤回后第二次提交上市申请|新受理（3.3-3.9）

本周药品注册受理数据，分门别类呈现，一目了然。(3.3-3.9）新药上市申请药品名称企业注册分类受理号丁二酸复瑞替尼胶囊复星万邦(江苏)医药集团有限公司1CXHS2500021注射用维贝柯妥塔单抗乐普生物科技股份有限公司1CXSS2500034 新药临床申请药品名称企业注册分类受理号DZD8586片迪哲(江苏)医药股份有限公司1CXHL2500261HRS9531注射液福建盛迪医药有限公司1CXHL2500260HRS9531注射液福建盛迪医药有限公司1CXHL2500259TRD205片北京泰德制药股份有限公司1CXHL2500254TRD205片北京泰德制药股份有限公司1CXHL2500253PRT-064040鼻喷雾剂四川普锐特药业有限公司1CXHL2500257PRT-064040鼻喷雾剂四川普锐特药业有限公司1CXHL2500256PRT-064040鼻喷雾剂四川普锐特药业有限公司1CXHL2500255奎斯诺片中科南京生命健康高等研究院1CXHL2500245HS-10510片江苏豪森药业集团有限公司1CXHL2500244HS-10510片江苏豪森药业集团有限公司1CXHL2500243MWN109片上海民为生物技术有限公司1CXHL2500241MWN109片上海民为生物技术有限公司1CXHL2500240MWN109片上海民为生物技术有限公司1CXHL2500239SGB-3383注射液苏州圣因生物医药有限公司1CXHL2500238MWN109片上海民为生物技术有限公司1CXHL2500237MWN109片上海民为生物技术有限公司1CXHL2500236MWN109片上海民为生物技术有限公司1CXHL2500235MWN109片上海民为生物技术有限公司1CXHL2500234MWN109片上海民为生物技术有限公司1CXHL2500242KEM2403注射液深圳珐玛易药品科技有限公司2.1CXHL2500258KEM2418缓释直服颗粒深圳珐玛易药品科技有限公司2.2CXHL2500252利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500250利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500249利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500248利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500247利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500246优替德隆胶囊成都华昊中天药业有限公司2.2;2.4CXHL2500251SMF-217江西施美药业股份有限公司2.3CXHL25002336价B族链球菌结合疫苗苏州聚微生物科技有限公司1.1CXSL2500190LVRNA015珠海丽凡达生物技术有限公司1.2CXSL2500208重组带状疱疹疫苗(CHO细胞)长春百克生物科技股份公司1.3CXSL2500213ACYW135X群脑膜炎球菌多糖结合疫苗北京科兴中维生物技术有限公司1.4CXSL2500200注射用JS203上海君实生物医药科技股份有限公司1CXSL2500212SH006注射液南京圣和药业股份有限公司1CXSL2500211BPR-102胶囊成都倍特益康恩生物医药科技有限公司1CXSL2500210BPR-102胶囊成都倍特益康恩生物医药科技有限公司1CXSL2500209SHR-4712注射液广东恒瑞医药有限公司1CXSL2500207SHR-4712注射液广东恒瑞医药有限公司1CXSL2500206注射用CS2009申石生物医药(上海)有限公司1CXSL2500205IMM27M注射液宜明昂科生物医药技术(上海)股份有限公司1CXSL2500204TQB2930注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2500203TQB2930注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2500202CM336注射液康诺亚生物医药科技(成都)有限公司1CXSL2500201注射用重组人源化抗BCMA/CD3双特异性抗体山东新时代药业有限公司1CXSL2500199FB1002重组人源化单克隆抗体注射液福贝生物医药科技(北京)有限公司1CXSL2500192REGEND003细胞自体回输制剂上海吉锐医学科技有限公司1CXSL2500196皮炎诊断贴剂02贴浙江我武生物科技股份有限公司1CXSL2500195皮炎诊断贴剂02贴浙江我武生物科技股份有限公司1CXSL2500194皮炎诊断贴剂02贴浙江我武生物科技股份有限公司1CXSL2500193注射用FP008珠海菲鹏制药有限公司1CXSL2500191注射用BGB-B455广州百济神州生物制药有限公司1CXSL2500198NTB003注射液南京正大天晴制药有限公司1CXSL2500197 仿制药申请药品名称企业注册分类受理号盐酸丁螺环酮片河北龙海药业有限公司3CYHS2500983盐酸多沙普仑注射液成都瑞尔医药科技有限公司3CYHS2500976盐酸普罗帕酮注射液南阳普康恒旺药业有限公司3CYHS2500968盐酸异丙肾上腺素注射液绪必迪药业(沧州)有限公司3CYHS2500967维生素K滴剂四川海梦智森生物制药有限公司3CYHS2500965盐酸多巴酚丁胺注射液武汉市金恒泰药业有限公司3CYHS2500964盐酸美金刚口腔崩解片合肥恩瑞特药业有限公司3CYHS2500954盐酸美金刚口腔崩解片合肥恩瑞特药业有限公司3CYHS2500953溴吡斯的明片吉林省博大伟业制药有限公司3CYHS2500951西格列汀二甲双胍缓释片河北天成药业股份有限公司3CYHS2500941盐酸溴己新口服溶液北京双鹭药业股份有限公司3CYHS2500940维生素B6注射液汇禹远和(海南)药业有限公司3CYHS2500939洛索洛芬钠口服溶液浙江高跖医药科技股份有限公司3CYHS2500933醋酸特利加压素注射液成都天台山制药股份有限公司3CYHS2500927福多司坦口服溶液江苏润恒制药有限公司3CYHS2500925美洛昔康纳米晶注射液扬子江药业集团有限公司3CYHS2500924洛索洛芬钠口服溶液安徽杰玺医药有限公司3CYHS2500923聚乙二醇3350散合肥盛秦医药科技有限公司3CYHS2500920法莫替丁注射液南京正科医药股份有限公司3CYHS2500914法莫替丁注射液南京正科医药股份有限公司3CYHS2500913盐酸多西环素片德全药品(江苏)股份有限公司3CYHS2500910醋氯芬酸片合肥英太制药有限公司3CYHS2500909艾曲泊帕乙醇胺干混悬剂湖北民康药业集团有限公司3CYHS2500908硫代硫酸钠注射液苏州朗科生物技术股份有限公司3CYHS2500905硫代硫酸钠注射液苏州朗科生物技术股份有限公司3CYHS2500904硝普钠注射液康普药业股份有限公司3CYHS2500903醋酸地非法林注射液齐鲁制药(海南)有限公司3CYHS2500902头孢地尼干混悬剂广东万泰科创药业有限公司3CYHS2500901碳酸司维拉姆干混悬剂中美华世通生物医药科技(武汉)股份有限公司3CYHS2500900碳酸司维拉姆干混悬剂中美华世通生物医药科技(武汉)股份有限公司3CYHS2500899熊去氧胆酸颗粒辽宁海一制药有限公司3CYHS2500897阿瑞匹坦注射液石药集团中诺药业(石家庄)有限公司3CYHS2500896葡萄糖酸钙氯化钠注射液湖北津药药业股份有限公司3CYHS2500895阿昔莫司胶囊安徽佳和药业有限公司4CYHS2500986来特莫韦注射液石家庄四药有限公司4CYHS2500985盐酸贝尼地平片石家庄四药有限公司4CYHS2500984比索洛尔氨氯地平片山东益康药业股份有限公司4CYHS2500982培哚普利氨氯地平片(III)南京海纳制药有限公司4CYHS2500981蒙脱石混悬液湖北午时药业股份有限公司4CYHS2500980布洛芬混悬液珠海联邦制药股份有限公司4CYHS2500979注射用紫杉醇(白蛋白结合型)浙江圣兆药物科技股份有限公司4CYHS2500978厄贝沙坦氢氯噻嗪片天津华津制药有限公司4CYHS2500977洛索洛芬钠凝胶贴膏湖北民康药业集团有限公司4CYHS2500975沙库巴曲缬沙坦钠片辽宁鑫善源药业有限公司4CYHS2500974沙库巴曲缬沙坦钠片辽宁鑫善源药业有限公司4CYHS2500973沙库巴曲缬沙坦钠片辽宁鑫善源药业有限公司4CYHS2500972甲磺酸沙非胺片上海上药中西制药有限公司4CYHS2500971甲磺酸沙非胺片上海上药中西制药有限公司4CYHS2500970硫酸氨基葡萄糖胶囊安徽佳和药业有限公司4CYHS2500969甲磺酸倍他司汀片北京紫萌医药科技有限公司4CYHS2500966沙库巴曲缬沙坦钠片江苏中邦制药有限公司4CYHS2500963沙库巴曲缬沙坦钠片江苏中邦制药有限公司4CYHS2500962酮洛芬凝胶苏州高迈药业有限公司4CYHS2500961依达拉奉氯化钠注射液福建天泉药业股份有限公司4CYHS2500960瑞舒伐他汀依折麦布片(I)浙江京新药业股份有限公司4CYHS2500959盐酸羟考酮缓释片北京华素制药股份有限公司4CYHS2500958注射用硫酸艾沙康唑南京易亨制药有限公司4CYHS2500956氢溴酸替格列汀片浙江诺得药业有限公司4CYHS2500955硝酸异山梨酯注射液江苏润恒制药有限公司4CYHS2500952盐酸奥布卡因滴眼液海南斯达制药有限公司4CYHS2500950布瑞哌唑片山东鲁抗医药股份有限公司4CYHS2500949布瑞哌唑片山东鲁抗医药股份有限公司4CYHS2500948布瑞哌唑片山东鲁抗医药股份有限公司4CYHS2500947左乙拉西坦口服溶液江苏润恒制药有限公司4CYHS2500946盐酸二甲双胍片石家庄市普力制药有限公司4CYHS2500945盐酸二甲双胍片石家庄市普力制药有限公司4CYHS2500944玻璃酸钠滴眼液润尔眼科药物(广州)有限公司4CYHS2500943美阿沙坦钾片珠海润都制药股份有限公司4CYHS2500957硫酸镁钠钾口服用浓溶液湖北民康药业集团有限公司4CYHS2500938左乙拉西坦片北京世桥生物制药有限公司4CYHS2500937左乙拉西坦片北京世桥生物制药有限公司4CYHS2500936卡泊三醇软膏东阳祥昇医药科技有限公司4CYHS2500935西格列汀二甲双胍片(Ⅱ)北京元延医药科技股份有限公司4CYHS2500934氟比洛芬凝胶贴膏浙江高跖医药科技股份有限公司4CYHS2500932洛索洛芬钠凝胶贴膏浙江高跖医药科技股份有限公司4CYHS2500942巴瑞替尼片广州绿十字制药股份有限公司4CYHS2500931巴瑞替尼片广州绿十字制药股份有限公司4CYHS2500930聚多卡醇注射液广东万泰科创药业有限公司4CYHS2500929聚多卡醇注射液广东万泰科创药业有限公司4CYHS2500928莫匹罗星软膏湖北科田药业有限公司4CYHS2500926依折麦布辛伐他汀片浙江亚瑟医药有限公司4CYHS2500922吗啉硝唑氯化钠注射液安徽威尔曼制药有限公司4CYHS2500921聚多卡醇注射液哈尔滨誉衡制药有限公司4CYHS2500919聚多卡醇注射液哈尔滨誉衡制药有限公司4CYHS2500918聚多卡醇注射液哈尔滨誉衡制药有限公司4CYHS2500917乙酰半胱氨酸颗粒海南海神同洲制药有限公司4CYHS2500912乙酰半胱氨酸颗粒海南海神同洲制药有限公司4CYHS2500911小儿法罗培南钠颗粒江苏睿实生物科技有限公司4CYHS2500907甲硝唑凝胶湖北舒邦药业有限公司4CYHS2500906硫酸艾沙康唑胶囊广州市联瑞制药有限公司4CYHS2500916氧(液态)淄博鲁川气体有限公司4CYHS2500915地屈孕酮片河南泰丰生物科技有限公司4CYHS2500898布洛芬混悬液华益药业科技(安徽)有限公司4CYHS2500894氧(液态)沁阳京宇气体有限公司4CYHS2500893咪达唑仑鼻喷雾剂四川普锐特药业有限公司3CYHL2500057厄贝沙坦氨氯地平片杭州沐源生物医药科技有限公司3CYHL2500056瑞卢戈利片山西振东制药股份有限公司3CYHL2500055 进口申请药品名称企业注册分类受理号来特莫韦微片Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.5.1JXHS2500036来特莫韦微片Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.5.1JXHS2500035古塞奇尤单抗注射液Janssen-Cilag International NV2.2JXSS2500022伊奈利珠单抗注射液Horizon Therapeutics Ireland DAC2.2JXSS2500021布瑞哌唑片Hetero Labs Limited, Unit-V5.2JYHS2500013布瑞哌唑片Hetero Labs Limited, Unit-V5.2JYHS2500012布瑞哌唑片Hetero Labs Limited, Unit-V5.2JYHS2500011BMS-986365胶囊Celgene Corporation1JXHL2500036BI 1291583 片Boehringer Ingelheim International GmbH1JXHL2500035PF-06821497片Pfizer Inc.1JXHL2500034PF-06821497片Pfizer Inc.1JXHL2500033PF-07275315注射液Pfizer Inc.1JXSL2500035CagriSema注射液Novo Nordisk A/S1JXSL2500034CagriSema注射液Novo Nordisk A/S1JXSL2500033CagriSema注射液Novo Nordisk A/S1JXSL2500032CagriSema注射液Novo Nordisk A/S1JXSL2500031CagriSema注射液Novo Nordisk A/S1JXSL2500030PIT565Novartis Pharma AG1JXSL2500029 中药相关申请无注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

疫苗抗体药物偶联物申请上市临床申请

100 项与瑞卢戈利相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D10888	瑞卢戈利	L01XX	DB11853

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

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

未上市

10 条进展最快的记录,

后查看更多信息

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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

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)	廠淵範獵願簾遞鑰鹽齋(築獵餘願醖襯鏇範願鏇) = 糧鏇構選遞艱觸夢夢製選鑰蓋願餘艱觸繭夢窪 (選鬱淵繭艱淵艱壓艱衊, 3.2) 更多	积极	2025-02-13
				Relugolix 240 mg + Apalutamide 240 mg	廠淵範獵願簾遞鑰鹽齋(築獵餘願醖襯鏇範願鏇) = 餘築築膚範齋憲範願網選鑰蓋願餘艱觸繭夢窪 (選鬱淵繭艱淵艱壓艱衊, 8.0) 更多
ASCO_GU2025	N/A	-	5,274	relugolix (Nonmetastatic Prostate Cancer (nmPC))	鑰願製壓觸淵製構觸糧(鹽顧鑰醖鑰鬱簾艱餘鹽) = 顧襯衊窪壓憲廠鏇範糧鬱顧廠鹹獵顧觸艱廠醖 (蓋鹽獵築蓋範網餘襯構, ±10 [99]) 更多	-	2025-02-13
				relugolix (Metastatic Prostate Cancer (mPC))	鑰願製壓觸淵製構觸糧(鹽顧鑰醖鑰鬱簾艱餘鹽) = 遞艱齋構夢積鹹夢鏇鏇鬱顧廠鹹獵顧觸艱廠醖 (蓋鹽獵築蓋範網餘襯構, ±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))	網膚窪獵鏇顧淵鏇齋餘 = 選積醖糧鹹願鏇衊獵窪構齋壓獵繭願鏇廠鹹膚 (窪淵製齋夢觸糧簾製遞, 醖衊餘襯鬱網壓醖壓獵 ~ 鬱獵築糧構鏇衊築鏇衊) 更多	-	2024-06-25
				Placebo (Placebo (Group B))	網膚窪獵鏇顧淵鏇齋餘 = 網壓鬱鑰選夢膚積願蓋構齋壓獵繭願鏇廠鹹膚 (窪淵製齋夢觸糧簾製遞, 範鹹醖膚艱網築製憲鹹 ~ 觸壓淵築顧廠窪艱衊窪) 更多
NCT05467176 (OPTYX study, ASCO2024)	N/A	Usher综合征 PSA \| testosterone \| distant metastases	394	Relugolix monotherapy	襯鹹願獵鑰範積憲憲繭(齋願構蓋遞艱範淵醖衊) = 襯積顧積夢鏇顧築壓襯壓夢窪壓遞鹹窪範選遞 (繭鏇淵壓簾積淵餘繭選, 238.5) 更多	-	2024-05-24
ASCO2024	N/A	-	267	Relugolix	網遞構鑰繭選鹽鏇淵構(廠積鑰餘築願積襯遞選) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment 衊膚鬱壓積製淵製憲廠 (繭齋廠範壓顧遞選淵遞 )	-	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))	醖簾繭艱鹹選築製願觸 = 鏇糧鏇廠觸鏇構遞鑰鹹廠糧範鹽壓獵繭壓餘鏇 (繭製醖襯願積壓鹹構積, 築獵顧廠築壓窪醖蓋廠 ~ 遞夢廠鹹選遞鏇網選艱) 更多	-	2024-05-09
				Relugolix+E2/NETA (Relugolix Plus Delayed E2/NETA (Group B))	醖簾繭艱鹹選築製願觸 = 襯餘遞遞餘壓遞窪夢壓廠糧範鹽壓獵繭壓餘鏇 (繭製醖襯願積壓鹹構積, 獵窪鑰簾選選範廠製獵 ~ 糧鏇構襯簾廠鏇齋獵餘) 更多
AUA2024	N/A	晚期前列腺癌	-	Leuprolide	範鹹醖範鹽窪簾醖鹹餘(範廠鹽觸積醖壓網觸觸) = 範醖鬱壓鹹繭憲積夢廠壓製壓衊鑰餘選齋鹹顧 (製艱憲觸夢網淵製顧鏇 )	-	2024-05-01
				Relugolix	範鹹醖範鹽窪簾醖鹹餘(範廠鹽觸積醖壓網觸觸) = 鏇廠選構壓艱積繭夢鹹壓製壓衊鑰餘選齋鹹顧 (製艱憲觸夢網淵製顧鏇 )
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)	艱觸鏇鏇壓願製窪獵網(窪鏇願範願遞積積範鑰) = 5.7% 積網糧艱簾膚範齋襯憲 (構餘觸夢鏇鹹蓋齋壓觸 ) 更多	-	2024-02-01
NCT03085095 (HERO, ASCO_GU2024) 人工标引	临床3期	前列腺癌	25	Relugolix	遞顧鏇範鹹積鹽顧蓋積(範顧鑰網艱衊遞鹽蓋鹹) = 製獵簾憲醖鏇憲鬱膚憲廠遞鹹觸願範窪觸衊蓋 (顧選鬱壓遞餘醖鏇壓積, 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	遞壓衊衊製鑰醖淵鏇醖(願顧淵膚鹹製齋積憲鬱) = 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. 願鏇築齋鹹積範顧獵願 (夢壓範醖簾襯範憲簾繭 )	积极	2024-01-25