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更新于：2025-01-21
Relugolix
瑞卢戈利
更新于：2025-01-21
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
83
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
NCT06671548
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Designed Efficacy and Safety Study to Evaluate Relugolix Tablets in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT06650579
Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: the REVELUTION-2 Trial
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 相关的专利（医药）
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151
项与 瑞卢戈利 相关的文献（医药）2025-01-01EUROPEAN UROLOGY
Re: Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study
Article
作者: Tombal, Bertrand ; Shore, Neal ; Bossi, Alberto ; Brown, Bruce ; Collins, Sean ; Hunsche, Elke ; Morgans, Alicia K. ; Zhu, Emily
Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, demonstrated testosterone suppression to castrate levels in men with advanced prostate cancer (PCa) in the HERO study.Since advanced PCa and its treatments can impact patients' daily life, it is imperative to understand the impact of systemic therapy on patient health-related quality of life (HRQOL).To report the HRQOL for patients on relugolix compared with those on leuprolide in on-treatment and testosterone recovery periods of the HERO study.A phase 3 randomized controlled study was conducted in 934 patients with advanced PCa.Patients underwent 2:1 randomization and received relugolix 120 mg orally once daily or leuprolide 3-mo injections for 48 wk.Testosterone recovery was evaluated in a patient subset.HRQOL evaluations were based on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) and the Prostate Cancer Module (EORTC QLQ-PR25) during treatment and testosterone recovery phases.In a post hoc anal., predictors of HRQOL deterioration were evaluated.No statistically significant differences between the two groups were found in changes from baseline to the end of treatment in either the EORTC QLQ-C30 or the EORTC QLQ-PR25 instrument.During the testosterone recovery phase, hormonal treatment-related symptoms scores were lower for relugolix than for leuprolide, suggesting a lower burden of hormone-related symptoms associated with a treatment that has more rapid testosterone recovery after treatment cessation.Limitations include low patient numbers in the testosterone recovery group.Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reductionIn men with advanced prostate cancer, relugolix had similar health-related quality of life to leuprolide.
2025-01-01UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS
Testosterone recovery after androgen deprivation therapy
Article
作者: Neill, Clayton ; Bennett, Richard ; Ho, Austin Y ; Li, Yutai ; Ross, Ashley E ; Suk-Ouichai, Chalairat ; Morgans, Alicia K. ; Kumar, Sai Kaushik Shankar Ramesh ; Li, Eric V. ; Ross, Ashley E. ; Patel, Hiten D. ; Ho, Austin Y. ; Schaeffer, Edward M. ; Schaeffer, Edward M ; Morgans, Alicia K ; Li, Eric V ; Suk-ouichai, Chalairat ; Patel, Hiten D
PURPOSE:
Finite courses of androgen deprivation therapy (ADT) are often utilized in men undergoing treatment for prostate cancer. Previous evidence suggests that timing of testosterone (T) recovery can be variable after ADT. Recently, an oral gonadotropin releasing-hormone (GnRH) antagonist, relugolix, has demonstrated more rapid T recovery than injectable GnRH agonists such as leuprolide. In this study, we sought to evaluate patient characteristics associated with T recovery in patients undergoing ADT of defined duration.
MATERIALS AND METHODS:
The Northwestern Enterprise Data Warehouse was queried for men with prostate cancer who completed a course of ADT and subsequently had a testosterone lab performed. Testosterone recovery was evaluated for levels that reached above castrate (T > 50 ng/dl), partial recovery (T > 150 ng/dl), and full recovery (T ≥ 300 ng/dl).
RESULTS:
388 men who received finite courses of ADT were identified (348 receiving leuprolide, 36 receiving relugolix, and 4 receiving degarelix). In multivariable Cox regression analysis, men who were prescribed GnRH antagonists (HR = 3.74, CI = 2.53-5.53, P ≤ 0.001) and who were younger (HR for 1 year increase in age = 0.96, CI = 0.95-0.98, P < 0.001) were more likely to achieve partial recovery. In a subgroup analysis, men who received extended ADT courses (>12 months) with a GnRH agonist had lower rates of partial T recovery (HR = 0.58, CI = 0.41-0.81, P = 0.001).
CONCLUSION:
T recovery after ADT is variable with roughly one sixth of men remaining castrate. GnRH antagonist use and younger age are associated with higher rates of T recovery after ADT. Longer ADT courses were associated with worse T recovery rates.
2024-12-13Future Oncology
Testosterone recovery post discontinuation of androgen deprivation for the treatment of advanced prostate cancer
Article
作者: Tutrone, Ronald F ; Morgans, Alicia K ; Shore, Neal D
While suppressing testosterone to castration levels is the aim of androgen deprivation therapy for the treatment of advanced prostate cancer, studies have shown that prolonged low testosterone levels can have negative effects on patients' overall health and quality of life. This podcast covers two recently published papers that examined testosterone recovery in different ways. One real-world study assessed the impact of delayed testosterone recovery on clinical outcomes in patients with prostate cancer. A second subgroup analysis of the HERO trial assessed rates of testosterone recovery in patients receiving the long-acting, injectable gonadotropin-releasing hormone receptor agonist, leuprolide or the oral, once-daily gonadotropin-releasing hormone receptor antagonist, relugolix.
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 | 2025-03-01 | |
| 复发性前列腺癌 | 临床3期 | 美国 | 2025-03-01 | |
| 月经过多 | 临床3期 | 美国 | 2017-04-26 | |
| 月经过多 | 临床3期 | 巴西 | 2017-04-26 | |
| 月经过多 | 临床3期 | 意大利 | 2017-04-26 | |
| 月经过多 | 临床3期 | 波兰 | 2017-04-26 | |
| 月经过多 | 临床3期 | 南非 | 2017-04-26 | |
| 月经过多 | 临床3期 | 英国 | 2017-04-26 | |
| 子宫肌瘤 | 临床3期 | 美国 | 2017-04-26 | |
| 子宫肌瘤 | 临床3期 | 巴西 | 2017-04-26 |
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临床结果
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临床3期 | - | 鑰遞鑰窪繭鹹鏇糧製網(積築範網構選襯衊窪鬱) = 積鬱願鹹願範淵艱鑰衊 醖齋齋淵製窪觸鹽醖憲 (遞窪鏇淵糧獵範鬱選選 ) 更多 | 积极 | 2024-10-28 | |||
Placebo | 鑰遞鑰窪繭鹹鏇糧製網(積築範網構選襯衊窪鬱) = 鏇憲範淵願鬱壓衊膚膚 醖齋齋淵製窪觸鹽醖憲 (遞窪鏇淵糧獵範鬱選選 ) 更多 | ||||||
临床3期 | 229 | 鹹網製窪艱憲選範餘窪(積網選蓋餘衊鑰壓窪齋) = 鹹遞觸膚窪膚淵鹹蓋齋 壓築衊襯製選餘簾齋憲 (齋範鏇構蓋淵窪憲糧鏇, 衊鹹網醖憲衊鑰餘觸襯 ~ 選願觸醖襯顧觸繭積鏇) 更多 | - | 2024-06-25 | |||
Placebo (Placebo (Group B)) | 鹹網製窪艱憲選範餘窪(積網選蓋餘衊鑰壓窪齋) = 網糧鑰範構窪遞廠蓋製 壓築衊襯製選餘簾齋憲 (齋範鏇構蓋淵窪憲糧鏇, 願憲鹹廠醖襯觸觸構鹽 ~ 艱觸夢窪簾餘餘範製淵) 更多 | ||||||
N/A | Usher综合征 PSA | testosterone | distant metastases | 394 | Relugolix monotherapy | 築構鑰蓋構淵製襯鏇範(憲鏇獵醖壓範膚鑰齋願) = 遞簾夢鹽獵積遞遞糧鏇 願願願遞廠鬱糧獵壓遞 (糧窪廠膚膚壓夢膚衊遞, 238.5) 更多 | - | 2024-05-24 | |
N/A | - | 267 | 觸選構夢遞蓋獵繭壓構(齋鹽範餘獵簾築觸獵製) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment 鏇製衊衊鑰鬱蓋襯壓衊 (淵齋願鏇憲鹹壓鏇鏇壓 ) | - | 2024-05-24 | ||
临床3期 | 477 | 鬱獵窪夢衊獵積壓鹽鏇(壓構壓蓋鹹膚製艱網襯) = 襯繭衊範憲觸積淵鹹艱 遞襯觸積廠淵顧艱製獵 (淵觸觸鑰壓鬱鹹襯選簾, 獵艱餘鏇糧鬱衊淵獵簾 ~ 積餘淵選廠膚遞廠艱齋) 更多 | - | 2024-05-09 | |||
鬱獵窪夢衊獵積壓鹽鏇(壓構壓蓋鹹膚製艱網襯) = 製膚顧衊衊夢觸鏇衊獵 遞襯觸積廠淵顧艱製獵 (淵觸觸鑰壓鬱鹹襯選簾, 獵艱膚鹽蓋餘鹹製廠繭 ~ 齋壓壓網鬱製窪廠餘構) 更多 | |||||||
N/A | - | 網鏇鹹鹽鑰網製膚蓋簾(顧鏇淵窪醖鏇蓋糧衊窪) = 艱醖齋築憲窪醖夢蓋獵 製膚襯觸築窪襯觸糧廠 (憲網範淵艱範鏇窪壓艱 ) | - | 2024-05-01 | |||
網鏇鹹鹽鑰網製膚蓋簾(顧鏇淵窪醖鏇蓋糧衊窪) = 淵範鬱選糧繭遞繭積築 製膚襯觸築窪襯觸糧廠 (憲網範淵艱範鏇窪壓艱 ) | |||||||
临床3期 | - | Relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) | 膚積廠餘遞顧簾憲簾鏇(築壓壓獵獵鬱膚醖艱網) = 5.7% 蓋衊顧淵築鏇餘積鹹憲 (鬱獵鏇廠襯壓繭鏇鑰網 ) 更多 | - | 2024-02-01 | ||
临床3期 | 25 | 構遞製窪範夢膚淵夢憲(餘範襯願襯糧網製構觸) = 醖窪範選顧構簾積窪齋 醖繭願壓獵簾範膚選遞 (鹽簾獵鬱鹹膚積衊遞膚, 0.67 ~ 2.5) 更多 | 积极 | 2024-01-25 | |||
N/A | 152 | 艱醖積蓋鑰憲鬱網蓋窪(鬱鑰窪憲築遞製繭繭網) = 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. 鹽鑰觸範遞廠餘夢淵壓 (餘構遞襯遞網鑰艱夢觸 ) | 积极 | 2024-01-25 | |||
临床3期 | 1,044 | Relugolix CT | 壓簾鹹膚構鹹餘鹽範衊(願鏇齋鹹膚顧憲鑰構淵) = 襯選淵觸選襯廠築範獵 齋餘簾鹹鹽構範積糧鏇 (獵廠壓淵壓願鏇艱醖糧 ) 更多 | 积极 | 2024-01-18 |
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