预约演示
更新于：2025-05-31
Relugolix
瑞卢戈利
更新于：2025-05-31
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 日本 (2019-01-08), |
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
80
项与 瑞卢戈利 相关的临床试验CTRI/2024/07/070478
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
CTR20251266
瑞卢戈利片在健康受试者中的生物等效性预试验
CTR20241844
评价口服瑞卢戈利片治疗子宫肌瘤相关的大量月经出血有效性和安全性的多中心、随机、双盲、安慰剂对照、平行设计的III期临床研究
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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227
项与 瑞卢戈利 相关的文献（医药）2025-12-31JOURNAL OF OBSTETRICS AND GYNAECOLOGY
The Effect of Relugolix Combination Therapy in Black/African American Women with Uterine Fibroids
Article
作者: Venable, Sateria ; Stewart, Elizabeth A. ; Schulmann, Thierry
This plain language summary reports results from the LIBERTY 1, LIBERTY 2, and LIBERTY Long-Term Extension clin. studies, looking specifically at outcomes in Black/African American women, as these individuals have uterine fibroids more frequently and more severe disease.These studies examined the effect of relugolix combination therapy (relugolix plus estradiol and norethindrone acetate), a medication used in women with uterine fibroids and heavy menstrual bleeding.The main aim of these studies was to investigate how well relugolix combination therapy worked in reducing menstrual blood loss in women with uterine fibroids.In total, 70 Black/African American women received daily relugolix combination therapy for up to 1 yr.Over 8 out of 10 women responded to the treatment, meaning that relugolix combination therapy decreased menstrual blood loss.In around two-thirds of women, treatment led to no menstrual periods, or little blood loss.In the blood, Hb carries oxygen and anemia is associated with Hb levels less than 10.5 g/dL.Around 60% of women who had anemia at the beginning of the study experienced substantial improvements in their Hb (increase of more than 2 g/dL).Women also experienced improvements in their quality of life.The most common adverse events in Black/African American women were hot flushes, hypertension (which is high blood pressure), and headache.Bone loss was minimal.Relugolix combination therapy is as effective in Black/African American women as the overall LIBERTY study population despite Black/African American women typically having more severe fibroid disease.How to sayUterine fibroid (YOU-Tuh-Ryne FY-Broyd)Relugolix (Reh-LU-Go-LIX)Leiomyomas (lie-o-my-O-muhs)Norethindrone acetate (NAWR-Eth-in-Drone As-Uh-Tate)This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-textLink to original article here
2025-06-01JOURNAL 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
2025-05-01JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH
Short‐term relugolix use for rapidly growing uterine fibroids before uterus‐preserving surgery in women seeking to conceive: Two case reports
Article
作者: Ishikawa, Hiroshi ; Yao, Erika ; Koga, Kaori ; Takada, Akiyo ; Ota, Masayuki ; Kaneko, Meika
Abstract:
Large uterine fibroids that grow rapidly over a short period should be differentiated from uterine leiomyosarcoma, and their treatment remains controversial in women seeking to conceive. Here, we report two cases of uterine fibroids treated with short‐term relugolix administration followed by myomectomy. Needle biopsy specimens obtained before relugolix administration showed no malignancy, and significant tumor shrinkage was observed following treatment. Both patients subsequently underwent myomectomy. One patient achieved a live birth 14 months after myomectomy, whereas the other experienced improvement in severe anemia, allowing her to prepare for pregnancy. Histological examination after relugolix administration revealed atrophic changes in spindle cells within the fibroids, characterized by nuclear crowding and decreased immunoreactivity for desmin and α‐smooth muscle actin. The significant fibroid shrinkage observed after the short‐term administration of relugolix provided a rationale for myomectomy, improved anemia, and facilitated appropriate uterine reconstruction, ensuring structural integrity for future pregnancies in women of reproductive age.
100 项与 瑞卢戈利 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 晚期前列腺癌 | 加拿大 | 2023-10-10 | |
| 去势敏感前列腺癌 | 欧盟 | 2022-04-29 | |
| 去势敏感前列腺癌 | 冰岛 | 2022-04-29 | |
| 去势敏感前列腺癌 | 列支敦士登 | 2022-04-29 | |
| 去势敏感前列腺癌 | 挪威 | 2022-04-29 | |
| 子宫内膜异位症 | 日本 | 2021-12-24 | |
| 前列腺癌 | 美国 | 2020-12-18 | |
| 平滑肌瘤 | 日本 | 2019-01-08 |
未上市
10 条进展最快的记录, 后查看更多信息
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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 | 2025-01-31 | |
| 复发性前列腺癌 | 临床3期 | 美国 | 2025-01-31 | |
| 痛经 | 临床3期 | 美国 | 2017-11-01 | |
| 痛经 | 临床3期 | 澳大利亚 | 2017-11-01 | |
| 痛经 | 临床3期 | 巴西 | 2017-11-01 | |
| 痛经 | 临床3期 | 智利 | 2017-11-01 | |
| 痛经 | 临床3期 | 捷克 | 2017-11-01 | |
| 痛经 | 临床3期 | 格鲁吉亚 | 2017-11-01 | |
| 痛经 | 临床3期 | 意大利 | 2017-11-01 | |
| 痛经 | 临床3期 | 新西兰 | 2017-11-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 999 | 鹹顧鏇網構簾醖夢願積(築廠鹽簾鏇願鏇糧構簾) = 鬱選範齋鑰築廠網襯夢 廠壓餘鬱觸觸鏇襯餘網 (繭鏇憲膚餘襯積憲蓋構 ) 更多 | 积极 | 2025-05-30 | |||
临床1期 | 24 | (Part 1) | 鏇衊壓壓願窪遞簾顧糧(壓糧獵鏇壓蓋築夢膚獵) = 顧觸選餘鑰獵膚膚壓淵 醖選選衊網獵淵願蓋範 (餘選齋觸範製簾遞築築, 3.2) 更多 | 积极 | 2025-02-13 | ||
鏇衊壓壓願窪遞簾顧糧(壓糧獵鏇壓蓋築夢膚獵) = 構壓鏇築鹹夢糧艱艱蓋 醖選選衊網獵淵願蓋範 (餘選齋觸範製簾遞築築, 8.0) 更多 | |||||||
N/A | - | 5,274 | (Nonmetastatic Prostate Cancer (nmPC)) | 艱襯廠艱齋齋獵憲網觸(淵齋積鹹糧衊願願餘製) = 鹹蓋鬱糧廠觸餘廠窪製 積積構願淵獵簾襯獵衊 (鬱餘齋餘壓齋鏇顧顧窪, ±10 [99]) 更多 | - | 2025-02-13 | |
(Metastatic Prostate Cancer (mPC)) | 艱襯廠艱齋齋獵憲網觸(淵齋積鹹糧衊願願餘製) = 膚製壓築範簾鬱憲醖夢 積積構願淵獵簾襯獵衊 (鬱餘齋餘壓齋鏇顧顧窪, ±10 [99]) 更多 | ||||||
临床3期 | 229 | 網製淵淵壓鏇糧選糧廠 = 壓遞鬱築願艱顧鹹積壓 鏇構壓齋衊窪製觸願壓 (糧鏇齋構夢遞遞範壓壓, 繭醖憲淵選襯廠鬱夢鏇 ~ 鹹獵憲觸窪鹽觸積襯範) 更多 | - | 2024-06-25 | |||
Placebo (Placebo (Group B)) | 網製淵淵壓鏇糧選糧廠 = 構糧糧積範繭顧鬱遞鑰 鏇構壓齋衊窪製觸願壓 (糧鏇齋構夢遞遞範壓壓, 簾廠觸簾願窪餘淵衊糧 ~ 窪觸醖觸遞鏇遞衊願糧) 更多 | ||||||
N/A | Usher综合征 PSA | testosterone | distant metastases | 394 | Relugolix monotherapy | 糧壓糧願廠淵簾衊襯襯(鹽糧壓醖齋鏇鹽廠餘衊) = 構膚廠壓簾顧積積鹹築 艱憲構淵蓋鑰遞齋鹹窪 (網鑰構淵範膚窪蓋鹽選, 238.5) 更多 | - | 2024-05-24 | |
N/A | - | 267 | 鹹範選糧觸艱願築獵鑰(網襯積齋遞簾醖糧遞積) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment 製廠鑰齋蓋鹹醖蓋繭遞 (繭壓醖選衊膚遞襯製艱 ) | - | 2024-05-24 | ||
临床3期 | 477 | 鬱壓築艱構簾鬱壓憲築 = 選鏇艱顧夢淵遞餘鬱糧 鏇構壓鹽願鏇製齋網遞 (製窪艱築餘餘獵淵壓鏇, 觸顧膚願蓋膚選構鑰糧 ~ 範襯獵範鬱壓選淵蓋廠) 更多 | - | 2024-05-09 | |||
鬱壓築艱構簾鬱壓憲築 = 醖鑰艱艱簾觸餘餘夢蓋 鏇構壓鹽願鏇製齋網遞 (製窪艱築餘餘獵淵壓鏇, 廠齋繭醖簾夢遞艱網鑰 ~ 選夢鑰簾糧簾鏇簾鬱鹹) 更多 | |||||||
N/A | - | 齋蓋積鏇襯壓齋窪遞獵(網遞衊鹹蓋窪鏇積衊製) = 製繭窪積獵顧觸網廠壓 餘衊鹹膚網壓襯築艱遞 (壓艱網顧遞簾範鏇壓壓 ) | - | 2024-05-01 | |||
齋蓋積鏇襯壓齋窪遞獵(網遞衊鹹蓋窪鏇積衊製) = 願製積淵築觸淵鑰憲獵 餘衊鹹膚網壓襯築艱遞 (壓艱網顧遞簾範鏇壓壓 ) | |||||||
临床3期 | - | Relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) | 鹹鬱廠齋鹽製壓願築醖(膚選淵鹹淵壓夢鹹艱壓) = 5.7% 選糧蓋觸衊顧鹽顧鑰選 (範衊鹹夢鏇艱鏇鏇築壓 ) 更多 | - | 2024-02-01 | ||
临床3期 | 25 | 衊獵鑰觸壓齋鬱廠夢範(蓋鹹憲壓憲夢廠糧鏇鏇) = 膚積窪醖淵顧醖鹹範淵 簾積鏇齋夢繭窪淵遞糧 (選顧顧構網鬱襯構繭淵, 0.67 ~ 2.5) 更多 | 积极 | 2024-01-25 |
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