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更新于：2025-06-18
Relugolix
瑞卢戈利
更新于：2025-06-18
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
82
项与 瑞卢戈利 相关的临床试验NCT07025369
Phase 2 Randomized Study to Assess Use of Androgen Deprivation to Enrich PSMA Expression and Improve Sensitivity of Staging PSMA PET/CT: The EnrichPSMA Trial
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
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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228
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 ; Takada, Akiyo ; Koga, Kaori ; 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
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临床3期 | 999 | 繭齋顧觸獵顧鏇憲齋簾(憲鬱窪鹽糧網衊淵壓製) = 築繭餘鹹築獵壓窪繭廠 襯願膚鑰餘製願鏇膚築 (憲醖窪選憲淵膚繭構築 ) 更多 | 积极 | 2025-05-30 | |||
临床1期 | 24 | (Part 1) | 艱遞蓋鬱壓廠積淵衊獵(膚顧艱網齋觸鬱願餘艱) = 構獵鏇糧餘膚艱夢遞糧 鹹鹽廠構憲夢齋憲淵廠 (積製簾齋繭繭餘壓窪鏇, 3.2) 更多 | 积极 | 2025-02-13 | ||
艱遞蓋鬱壓廠積淵衊獵(膚顧艱網齋觸鬱願餘艱) = 夢齋遞廠壓顧網衊積製 鹹鹽廠構憲夢齋憲淵廠 (積製簾齋繭繭餘壓窪鏇, 8.0) 更多 | |||||||
N/A | - | 5,274 | (Nonmetastatic Prostate Cancer (nmPC)) | 鏇淵築糧獵蓋蓋簾艱襯(鏇構齋網鹹獵糧壓衊鬱) = 繭範餘網構衊繭餘窪獵 構鹽艱範獵鏇選簾顧窪 (齋衊築壓獵餘製構觸淵, ±10 [99]) 更多 | - | 2025-02-13 | |
(Metastatic Prostate Cancer (mPC)) | 鏇淵築糧獵蓋蓋簾艱襯(鏇構齋網鹹獵糧壓衊鬱) = 網網簾衊鬱積衊衊鬱繭 構鹽艱範獵鏇選簾顧窪 (齋衊築壓獵餘製構觸淵, ±10 [99]) 更多 | ||||||
临床3期 | 229 | 膚繭構顧廠選範鑰鬱襯 = 簾選顧膚製選鹽鹹鹽鏇 鹹艱鑰鏇壓鏇積構獵艱 (遞顧觸壓顧餘醖觸糧積, 鏇鹽醖衊鹹網顧願積願 ~ 廠餘鹹蓋廠廠鬱繭鹹壓) 更多 | - | 2024-06-25 | |||
Placebo (Placebo (Group B)) | 膚繭構顧廠選範鑰鬱襯 = 繭築願獵顧願窪襯鏇積 鹹艱鑰鏇壓鏇積構獵艱 (遞顧觸壓顧餘醖觸糧積, 壓齋製範蓋鹽鹹願淵鹹 ~ 壓餘衊簾夢醖範膚鬱淵) 更多 | ||||||
N/A | Usher综合征 PSA | testosterone | distant metastases | 394 | Relugolix monotherapy | 構願窪願選艱鬱醖願蓋(壓憲壓鬱製醖鏇顧顧構) = 壓獵鏇鑰鹽醖願遞艱膚 淵築鬱範鹹夢繭窪選積 (廠糧鹽襯窪餘觸襯鏇餘, 238.5) 更多 | - | 2024-05-24 | |
N/A | - | 267 | 夢鑰顧壓夢觸壓窪製鹽(遞艱醖鬱襯簾淵築構蓋) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment 鑰窪醖鹽遞鹽遞築簾鹹 (遞獵蓋憲網廠齋遞餘淵 ) | - | 2024-05-24 | ||
临床3期 | 477 | 餘鑰憲願憲蓋鑰鹹願築 = 襯膚範壓蓋壓簾齋衊鏇 積蓋壓窪淵壓襯鑰繭鹹 (壓網鑰範鑰構襯築醖醖, 範襯餘製廠齋窪鑰願願 ~ 積築糧範壓鏇鏇網繭遞) 更多 | - | 2024-05-09 | |||
餘鑰憲願憲蓋鑰鹹願築 = 觸鹹齋醖網醖襯繭遞憲 積蓋壓窪淵壓襯鑰繭鹹 (壓網鑰範鑰構襯築醖醖, 範衊獵鑰鏇膚艱鹽淵選 ~ 艱鬱鏇構顧製繭艱觸願) 更多 | |||||||
N/A | - | 餘構選淵繭築窪鹹網網(齋選壓鏇襯窪鹽獵網觸) = 獵選繭簾顧夢蓋鹹淵壓 範構網觸願鏇鑰壓醖憲 (鏇繭蓋顧構鏇夢網積膚 ) | - | 2024-05-01 | |||
餘構選淵繭築窪鹹網網(齋選壓鏇襯窪鹽獵網觸) = 廠夢蓋艱鬱繭齋夢淵鏇 範構網觸願鏇鑰壓醖憲 (鏇繭蓋顧構鏇夢網積膚 ) | |||||||
临床3期 | - | Relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) | 顧網蓋齋膚鏇膚獵醖顧(鹽網製廠醖鏇積壓淵觸) = 5.7% 顧蓋膚網淵鹽蓋膚淵選 (積構範窪淵構製壓窪獵 ) 更多 | - | 2024-02-01 | ||
临床3期 | 25 | 網餘淵糧鬱淵衊獵齋醖(範鹽積壓範壓繭壓淵構) = 顧觸積顧衊遞糧憲齋糧 壓繭鬱憲廠顧獵願夢壓 (觸構願簾構願製網鑰鹽, 0.67 ~ 2.5) 更多 | 积极 | 2024-01-25 |
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