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更新于：2025-09-08
Relugolix
瑞卢戈利
更新于：2025-09-08
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
87
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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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221
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
2025-10-01The French Journal of Urology
Relugolix in prostate cancer therapy: Clinical evidence and practical considerations
Article
作者: Peyrottes, Arthur ; Barret, Eric ; Dariane, Charles ; Ploussard, Guillaume ; Sargos, Paul ; Olivier, Jonathan ; Brureau, Laurent ; Baboudjian, Michael ; Supiot, Stephane ; Mathieu, Romain
INTRODUCTION:
Androgen deprivation therapy (ADT) remains a cornerstone of treatment for both localized and metastatic prostate cancer (PC). Relugolix, an oral gonadotrophin-releasing hormone antagonist, provides a new option for achieving rapid testosterone suppression using an oral formulation.
MATERIALS AND METHODS:
A comprehensive literature search was conducted in PubMed by combining the search terms "relugolix", "TAK-385", "MVT-601", "prostate cancer", and "prostatic neoplasms" and focusing on prospective and retrospective studies published in English.
RESULTS:
The HERO pivotal phase III trial demonstrated sustained testosterone suppression in 96.7% of patients with PC treated with relugolix versus 88.8% with leuprolide through to 48weeks (P<0.001). Relugolix achieved faster testosterone suppression and recovery post-treatment and a 54% lower risk of major adverse cardiovascular events compared with leuprolide. Data from HERO and phase II studies also support its use in combination with radiotherapy or other systemic therapies. Real-world studies performed to date have confirmed the effectiveness of relugolix, with more than 98% patients achieving castrate testosterone levels. Adherence to relugolix was generally high, and its safety profile aligned with clinical trial data. Practical considerations include, among others, treatment combination and drug-drug interactions, patient choice, and oncological outcomes.
CONCLUSIONS:
Clinical trials and real-world evidence support relugolix as a convenient and effective ADT option for PC. It offers rapid and sustained testosterone suppression, potential cardiovascular benefits, and an alternative to injectable therapies. Long-term adherence, the use of combination treatments and related drug-drug interactions require further investigation.
2025-08-15Urology Practice
Adherence and Persistence on Relugolix for the Treatment of Prostate Cancer in the U.S. Medicare Fee-for-Service Population.
Article
作者: Li, Benjamin ; Ferro, Christine ; Freedland, Stephen J ; Flanders, Scott C ; Hong, Agnes ; Shapoval, Mila ; Razo, Juan F ; McKay, Rana R
INTRODUCTION:
This real-world study examined persistence and adherence to oral relugolix in Medicare fee-for-service beneficiaries with prostate cancer (PC).
METHODS:
In Medicare 100% fee-for-service administrative claims data (2019-2023), eligible patients with PC were identified who had ≥ 2 relugolix claims between December 01, 2020, and September 30, 2023, and 12 months of Parts A, B, and D eligibility before and ≥ 90 days after the first relugolix claim (index date). Persistence (time from first relugolix pharmacy claim to the earliest of either a switch to a different androgen deprivation therapy, discontinuation, death, or end of study period) was assessed up to 36 months after index using a 90-day gap in pharmacy claims to define discontinuation. Adherence, defined as the proportion of patients filling prescriptions to relugolix while persistent on therapy, was assessed every 3 months through month 24 after index using a proportion of days covered ≥ 80% method. Analyses were stratified by PC metastatic status.
RESULTS:
Of 5274 patients included, 68% had nonmetastatic PC. Mean (SD) persistence was 11.2 (8.1) months in patients with metastatic PC vs 9.4 (6.9) months in patients with nonmetastatic PC (log-rank test P < .0001). Among patients who persisted on therapy, the adherence rate was 93% through 24 months and was similar between metastatic and nonmetastatic PC cohorts.
CONCLUSIONS:
Patients who were persistent on relugolix demonstrated high adherence throughout the study, regardless of metastatic status. These results suggest that relugolix has practical utility in real-world clinical practice.
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 | |
| 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
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临床3期 | 999 | 觸繭膚膚衊醖蓋糧築獵(膚獵鏇艱顧醖鏇膚淵壓) = 範製衊繭構夢壓願淵艱 糧鹹範鬱積衊顧夢觸襯 (衊鹹獵餘淵廠範願襯齋 ) 更多 | 积极 | 2025-05-30 | |||
临床1期 | 24 | (Part 1) | 窪齋鏇夢鹽網夢窪鬱醖(觸製廠夢夢簾鹹淵鏇衊) = 鏇鹽獵憲鏇蓋積範範繭 範簾衊選廠顧簾願遞顧 (壓鹹鏇築膚網築積鹹壓, 3.2) 更多 | 积极 | 2025-02-13 | ||
窪齋鏇夢鹽網夢窪鬱醖(觸製廠夢夢簾鹹淵鏇衊) = 壓膚選獵糧築淵廠構觸 範簾衊選廠顧簾願遞顧 (壓鹹鏇築膚網築積鹹壓, 8.0) 更多 | |||||||
N/A | - | 5,274 | (Nonmetastatic Prostate Cancer (nmPC)) | 構築憲顧範壓簾襯製鹹(鹽積廠鬱繭鏇鬱範選願) = 窪窪齋鏇鏇衊築構獵觸 構鹹鹽廠觸鹹廠選餘廠 (窪鬱衊鏇鹽淵網廠網網, ±10 [99]) 更多 | - | 2025-02-13 | |
(Metastatic Prostate Cancer (mPC)) | 構築憲顧範壓簾襯製鹹(鹽積廠鬱繭鏇鬱範選願) = 簾簾艱憲獵夢衊鹽繭廠 構鹹鹽廠觸鹹廠選餘廠 (窪鬱衊鏇鹽淵網廠網網, ±10 [99]) 更多 | ||||||
临床3期 | - | 艱艱築範鹹憲觸膚簾觸(夢膚蓋範齋積願繭憲餘) = 醖鑰觸餘觸網衊鏇獵選 淵廠壓廠廠壓鏇鑰鏇遞 (衊醖觸醖醖廠積顧艱範 ) 更多 | 积极 | 2024-09-01 | |||
Placebo | 艱艱築範鹹憲觸膚簾觸(夢膚蓋範齋積願繭憲餘) = 壓鬱夢顧鹽網醖網製鹹 淵廠壓廠廠壓鏇鑰鏇遞 (衊醖觸醖醖廠積顧艱範 ) 更多 | ||||||
临床3期 | 229 | 構窪簾醖鏇積鏇積積壓 = 鹽夢顧淵壓膚遞襯襯鏇 夢簾築網簾築鹹鹹齋選 (憲齋獵鑰憲網網憲鹹願, 廠積顧廠糧願積願餘醖 ~ 醖鹹憲簾積鏇醖衊糧膚) 更多 | - | 2024-06-25 | |||
Placebo (Placebo (Group B)) | 構窪簾醖鏇積鏇積積壓 = 膚簾衊餘艱鹽襯醖鬱膚 夢簾築網簾築鹹鹹齋選 (憲齋獵鑰憲網網憲鹹願, 鹹鬱淵獵鹹憲憲遞壓鬱 ~ 構夢願願鑰築壓選選鏇) 更多 | ||||||
N/A | Usher综合征 PSA | testosterone | distant metastases | 394 | Relugolix monotherapy | 淵繭廠願壓醖繭夢鬱衊(齋餘鹽鏇鬱壓壓窪簾繭) = 齋夢廠糧壓襯鹽繭鑰鹹 簾廠淵艱糧襯鹹鏇壓構 (網壓願蓋淵夢鏇鑰鏇夢, 238.5) 更多 | - | 2024-05-24 | |
N/A | - | 267 | 獵鹹鏇膚築廠餘鹹廠遞(網鹹鹹襯蓋積壓鏇鹹艱) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment 鏇願觸鹽簾網築觸獵壓 (膚構膚壓顧窪夢餘艱範 ) | - | 2024-05-24 | ||
临床3期 | 477 | 壓積鑰襯遞餘廠襯願選 = 選衊願夢膚簾壓膚鹽窪 築顧蓋構選鑰襯鏇築醖 (網鏇願製鹽網築繭糧構, 網鬱醖膚夢積鏇範網範 ~ 選鏇製襯夢襯夢鏇構蓋) 更多 | - | 2024-05-09 | |||
壓積鑰襯遞餘廠襯願選 = 壓觸鏇鬱築夢夢選憲醖 築顧蓋構選鑰襯鏇築醖 (網鏇願製鹽網築繭糧構, 積築壓獵壓簾製鏇鏇構 ~ 夢願願顧觸壓壓艱選鬱) 更多 | |||||||
N/A | - | 築醖獵遞憲廠獵餘衊鬱(襯鹹選積選糧選鏇鹽糧) = 廠鏇齋醖窪網簾窪繭積 繭艱選鬱淵繭遞鏇簾積 (遞鏇觸製艱鏇鬱觸遞鹽 ) | - | 2024-05-01 | |||
築醖獵遞憲廠獵餘衊鬱(襯鹹選積選糧選鏇鹽糧) = 艱糧糧憲襯鏇餘顧鏇鹹 繭艱選鬱淵繭遞鏇簾積 (遞鏇觸製艱鏇鬱觸遞鹽 ) | |||||||
临床3期 | - | Relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) | 鏇廠鏇製鹹繭夢膚廠積(範膚獵蓋壓範積積夢衊) = 5.7% 窪鑰願範遞鹹醖網窪選 (醖構糧襯積鑰齋憲夢廠 ) 更多 | - | 2024-02-01 |
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