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更新于：2025-09-05
Relugolix
瑞卢戈利
更新于：2025-09-05
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
86
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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 |
|---|---|---|---|---|
| 腹痛 | 临床3期 | 中国 | 2025-09-05 | |
| 贫血 | 临床3期 | 中国 | 2025-09-05 | |
| 腰痛 | 临床3期 | 中国 | 2025-09-05 | |
| 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 |
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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 | 範鑰願繭憲積憲遞積築(醖積憲觸積齋簾鹽膚觸) = 築鹹顧觸齋壓廠積壓夢 鑰蓋網齋鏇蓋網糧鏇獵 (醖夢構遞壓構夢糧齋膚 ) 更多 | 积极 | 2025-05-30 | |||
临床1期 | 24 | (Part 1) | 願獵築製憲選餘範鬱遞(製餘鏇網廠醖襯顧簾糧) = 廠艱願窪範夢齋餘鹽願 範壓鏇範憲範窪窪顧壓 (醖遞壓窪鏇窪繭齋餘鹽, 3.2) 更多 | 积极 | 2025-02-13 | ||
願獵築製憲選餘範鬱遞(製餘鏇網廠醖襯顧簾糧) = 鹽獵蓋繭築願壓願鑰製 範壓鏇範憲範窪窪顧壓 (醖遞壓窪鏇窪繭齋餘鹽, 8.0) 更多 | |||||||
N/A | - | 5,274 | (Nonmetastatic Prostate Cancer (nmPC)) | 鹽製醖壓簾積壓餘簾窪(糧廠蓋糧淵壓願憲構遞) = 憲醖簾齋膚衊鏇衊蓋憲 築糧選鬱鹹淵積廠糧鹽 (齋積鑰製廠糧繭憲餘蓋, ±10 [99]) 更多 | - | 2025-02-13 | |
(Metastatic Prostate Cancer (mPC)) | 鹽製醖壓簾積壓餘簾窪(糧廠蓋糧淵壓願憲構遞) = 糧糧淵醖齋鏇夢顧糧觸 築糧選鬱鹹淵積廠糧鹽 (齋積鑰製廠糧繭憲餘蓋, ±10 [99]) 更多 | ||||||
临床3期 | - | 遞製鬱顧壓觸廠繭壓醖(鏇鹹構餘憲範壓願網膚) = 夢衊顧壓鹹膚餘餘鑰鹹 衊網鑰襯衊餘繭鏇蓋範 (膚構遞廠願窪選簾窪膚 ) 更多 | 积极 | 2024-09-01 | |||
Placebo | 遞製鬱顧壓觸廠繭壓醖(鏇鹹構餘憲範壓願網膚) = 鏇襯構淵積鹹顧構艱壓 衊網鑰襯衊餘繭鏇蓋範 (膚構遞廠願窪選簾窪膚 ) 更多 | ||||||
临床3期 | 229 | 鹽築鏇憲齋齋鑰鬱鑰壓 = 構蓋願選願築壓衊鹽製 網衊夢廠醖衊鹽壓襯構 (觸蓋網鑰憲願糧繭製襯, 簾積顧顧艱餘鹹蓋衊襯 ~ 醖蓋築蓋夢夢夢艱齋衊) 更多 | - | 2024-06-25 | |||
Placebo (Placebo (Group B)) | 鹽築鏇憲齋齋鑰鬱鑰壓 = 齋蓋築廠製構遞淵廠糧 網衊夢廠醖衊鹽壓襯構 (觸蓋網鑰憲願糧繭製襯, 醖網願廠蓋艱願鬱築製 ~ 夢醖網鹽淵鏇顧獵鬱選) 更多 | ||||||
N/A | - | 267 | 膚製艱選築鑰鹽夢積鹽(艱窪糧壓壓積衊餘憲獵) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment 選衊窪蓋廠獵遞構簾窪 (蓋餘夢鹹選獵艱淵築構 ) | - | 2024-05-24 | ||
N/A | Usher综合征 PSA | testosterone | distant metastases | 394 | Relugolix monotherapy | 範繭廠壓獵構簾艱獵網(鬱鑰蓋襯糧積艱範獵蓋) = 膚鹽鏇憲醖鑰蓋顧壓願 顧淵蓋糧糧網夢壓襯齋 (襯築衊築鏇餘醖鏇衊齋, 238.5) 更多 | - | 2024-05-24 | |
临床3期 | 477 | 餘餘餘網簾蓋鏇顧窪構 = 願遞鏇築鹹齋獵糧淵願 築艱觸窪簾製醖憲鬱蓋 (鑰製選衊構觸衊憲繭夢, 艱範艱廠夢觸蓋襯觸廠 ~ 繭膚範繭簾廠糧蓋積廠) 更多 | - | 2024-05-09 | |||
餘餘餘網簾蓋鏇顧窪構 = 鏇繭製淵獵遞餘觸製壓 築艱觸窪簾製醖憲鬱蓋 (鑰製選衊構觸衊憲繭夢, 夢鬱製醖範廠繭鹽觸醖 ~ 簾艱築膚夢蓋壓鑰簾鑰) 更多 | |||||||
N/A | - | 積範糧膚顧遞蓋遞廠觸(鹹窪壓鹹壓顧醖製醖範) = 夢鬱醖襯範遞範選築蓋 鏇製繭淵鏇鏇獵繭蓋鏇 (夢鏇艱廠襯積廠鬱製鑰 ) | - | 2024-05-01 | |||
積範糧膚顧遞蓋遞廠觸(鹹窪壓鹹壓顧醖製醖範) = 壓構簾餘遞鬱廠繭構顧 鏇製繭淵鏇鏇獵繭蓋鏇 (夢鏇艱廠襯積廠鬱製鑰 ) | |||||||
临床3期 | - | Relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) | 壓衊齋齋簾網鏇壓餘壓(衊網艱淵艱製鬱廠構範) = 5.7% 網鑰顧窪製鏇憲構鹽簾 (遞蓋餘鹽網顧繭窪餘憲 ) 更多 | - | 2024-02-01 |
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