更新于：2024-11-04
Relugolix
瑞卢戈利
更新于：2024-11-04
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
分子式C29H27F2N7O5S |
InChIKeyAOMXMOCNKJTRQP-UHFFFAOYSA-N |
CAS号737789-87-6 |
关联
76
项与 瑞卢戈利 相关的临床试验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
Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: the REVELUTION-2 Trial
Comeback From Long coursE ADT With RElugolix and Darolutamide in Hormone-sensitive Prostate Cancer (CLEARED)
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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146
项与 瑞卢戈利 相关的文献（医药）2024-10-01FERTILITY AND STERILITY
Impact of relugolix combination therapy on functioning and quality of life in women with endometriosis-associated pain
Article
作者: Perry, Julie ; Reznichenko, Galyna ; Becker, Christian M ; Wilk, Krzysztof ; Soulban, Graziella ; Zhong, Yi ; Abrao, Mauricio S ; Hunsche, Elke ; As-Sanie, Sawsan
OBJECTIVE:
To evaluate the effect of relugolix combination therapy (relugolix CT; 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethisterone acetate) for up to 2 years in the SPIRIT long-term extension study on functioning and health-related quality of life (QoL), using the Endometriosis Health Profile (EHP)-30 questionnaire, and assess how changes in QoL domains correlated with improvements in dysmenorrhea as well as nonmenstrual pelvic pain (NMPP).
DESIGN:
Long-term extension study of the SPIRIT phase 3 trials.
SETTING:
Clinics and University Hospitals.
PATIENT(S):
Premenopausal women with moderate-to-severe endometriosis pain who previously completed the randomized SPIRIT trials were eligible to enroll in an 80-week long-term extension where all women received relugolix CT.
INTERVENTION(S):
Relugolix CT (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg).
MAIN OUTCOME MEASURE(S):
Least squares (LS) mean changes in the EHP-30 domain and total scores from baseline (pivotal) were analyzed using a mixed-effects model. Results up to 104 weeks are reported by a pivotal trial treatment group with a focus on the relugolix CT group (i.e., relugolix CT or placebo for 24 weeks, or delayed relugolix CT [relugolix 40 mg monotherapy for 12 weeks, followed by relugolix CT for 12 weeks]). In addition, the relationships between changes in dysmenorrhea and NMPP as well as changes in EHP-30 scores were assessed.
RESULT(S):
In the 277 women treated with relugolix CT, LS mean EHP-30 pain domain scores improved by 57.8% (LS mean change: -32.8; 95% CI: -35.5, -30.1), 66.4% (LS mean change: -37.7; 95% CI: -40.3, -35.0), and 72.2% (LS mean change: -41.3; 95% CI: -43.9, -38.7) at weeks 24, 52, and 104, respectively. The proportions of women with clinically meaningful improvement in the EHP-30 pain domain were 75.9%, 83.6%, and 88.6% at weeks 24, 52, and 104, respectively. Non-pain EHP-30 domain and total scores likewise improved. A positive correlation between changes in dysmenorrhea/NMPP and all EHP-30 domain scores was observed. Results were similar for the delayed relugolix CT and placebo → relugolix CT groups.
CONCLUSION(S):
Sustained reduction of endometriosis-associated pain with relugolix CT observed up to 104 weeks was accompanied by improvements in functioning and health-related QoL. These findings complement the results of the pivotal SPIRIT trials, which showed that relugolix combination therapy significantly reduced dysmenorrhea, NMPP, and dyspareunia vs. placebo in premenopausal women with endometriosis-associated pain.
CLINICAL TRIAL REGISTRATION NUMBER:
Registration/clinicaltrials.gov identifier: SPIRIT Extension Study (NCT03654274).
2024-10-01JOGNN-JOURNAL OF OBSTETRIC GYNECOLOGIC AND NEONATAL NURSING
Once Daily Oral Relugolix Combination Therapy Versus Placebo in Patients With Endometriosis-Associated Pain: Two Replicate Phase 3, Randomised, Double-Blind, Studies (SPIRIT 1 and 2)
Article
作者: Adams, Ellise D ; Adams, Ellise D.
The author describes the results of a study to examine the effect of three treatment regimens on pain associated with endometriosis.
2024-10-01CURRENT OPINION IN OBSTETRICS & GYNECOLOGY
Medical management of endometriosis
Review
作者: Abbott, Jason ; Alonso, Anais ; Gunther, Kate ; Maheux-Lacroix, Sarah
Purpose of review:
While laparoscopic surgery plays a key role in the management of endometriosis, symptoms commonly recur, and repeat surgery comes with increased risk. Medical management, including hormonal and nonhormonal treatment, is vital in managing painful symptoms. This review summarizes recent evidence regarding various medical management options available to treat pelvic pain associated with endometriosis.
Recent findings:
Efficacy of dienogest vs. combined oral contraceptive on pain associated with endometriosis: randomized clinical trial.Once daily oral relugolix combination therapy vs. placebo in patients with endometriosis-associated pain: two replicate phase 3, randomised, double-blind, studies (SPIRIT 1 and 2).A randomized, double-blind, placebo-controlled pilot study of the comparative effects of dienogest and the combined oral contraceptive pill in women with endometriosis.Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study.
Summary:
All symptomatic women with suspected endometriosis who are not desiring immediate fertility can be offered suppressive treatment to control symptoms and slow the progression of disease. First-line treatments include the combined oral contraceptive pill and progestogens. Second-line treatments include gonadotropin-releasing hormone agonists and antagonists but current guidelines recommend that these should be reserved for people whose symptoms fail to be controlled by first-line agents. The use of complementary and alternative medicines is also increasing in both volume and number of agents used.
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 | 2024-12-16 | |
| 复发性前列腺癌 | 临床3期 | 美国 | 2024-12-16 | |
| 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
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 229 | 觸夢齋遞鏇觸壓壓廠鹽(艱遞窪艱獵願艱鏇顧蓋) = 膚簾觸鏇遞鹹網鏇製鑰 鑰網壓鏇壓廠鑰鑰觸鏇 (鏇範淵餘廠遞膚艱鹽顧, 顧鹹襯顧願鹽淵鹹齋構 ~ 選獵顧夢餘齋鏇鑰夢艱) 更多 | - | 2024-06-25 | |||
Placebo (Placebo (Group B)) | 觸夢齋遞鏇觸壓壓廠鹽(艱遞窪艱獵願艱鏇顧蓋) = 顧憲鏇壓鹽蓋選繭獵鑰 鑰網壓鏇壓廠鑰鑰觸鏇 (鏇範淵餘廠遞膚艱鹽顧, 積醖繭構鬱鑰繭憲襯窪 ~ 鑰衊簾糧壓願壓憲構齋) 更多 | ||||||
N/A | Usher综合征 PSA | testosterone | distant metastases | 394 | Relugolix monotherapy | 獵餘淵壓窪醖淵簾觸壓(願鹽築範願醖鹹艱簾壓) = 遞鹹顧艱憲顧糧鹽獵窪 膚鹽窪衊範夢齋鬱淵繭 (廠鑰積鹹鹹範範窪網齋, 238.5) 更多 | - | 2024-05-24 | |
N/A | - | 267 | 襯廠構網觸膚簾衊顧鹽(觸襯窪選獵鹹積艱鏇壓) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment 鹽顧構齋範鬱遞鬱簾蓋 (窪鑰醖壓艱糧廠蓋繭鏇 ) | - | 2024-05-24 | ||
临床3期 | 477 | 觸鬱築憲憲廠糧築鹽艱(範積齋艱鹽淵積繭壓膚) = 網糧積鬱構鹹夢壓鬱繭 淵繭壓夢簾獵鑰廠壓衊 (鏇構觸製鏇繭齋顧繭構, 願窪夢願製網獵鹽積夢 ~ 積壓獵遞選廠鏇積鏇鹽) 更多 | - | 2024-05-09 | |||
觸鬱築憲憲廠糧築鹽艱(範積齋艱鹽淵積繭壓膚) = 壓膚鏇餘鬱構齋膚構醖 淵繭壓夢簾獵鑰廠壓衊 (鏇構觸製鏇繭齋顧繭構, 餘積醖遞繭夢壓齋醖齋 ~ 憲蓋顧構獵齋簾積夢壓) 更多 | |||||||
N/A | - | 積糧鹹獵繭簾艱膚觸醖(膚壓鏇糧窪蓋餘壓製窪) = 觸壓膚醖窪襯餘壓顧範 鏇襯衊簾製願鑰艱鑰簾 (衊淵築鑰膚鑰鏇窪夢鬱 ) | - | 2024-05-01 | |||
積糧鹹獵繭簾艱膚觸醖(膚壓鏇糧窪蓋餘壓製窪) = 衊鏇醖鏇構醖築餘蓋網 鏇襯衊簾製願鑰艱鑰簾 (衊淵築鑰膚鑰鏇窪夢鬱 ) | |||||||
N/A | - | Relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) | 鹹觸獵艱廠構願觸夢窪(齋願艱夢願餘窪築範構) = 5.7% 蓋醖範繭夢構餘簾積繭 (鹽鏇醖網衊簾構餘夢築 ) 更多 | - | 2024-02-01 | ||
N/A | 152 | 糧簾製憲積網膚顧鏇憲(夢網壓齋齋築窪鏇範獵) = 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. 齋鹽網淵顧觸壓願蓋遞 (築鹽顧獵獵廠顧夢網艱 ) | 积极 | 2024-01-25 | |||
临床3期 | 1,044 | Relugolix +oestradiol+norethisterone acetate | 鬱廠膚齋衊願獵製糧築(餘觸襯積餘齋窪壓獵觸) = 遞淵製選醖鬱觸觸願築 鬱齋簾夢壓艱顧鹹選鹹 (積觸窪獵憲齋襯選齋衊 ) 更多 | 积极 | 2024-01-18 | ||
临床3期 | 802 | 鹹網築網選遞網襯壓繭(壓鏇憲顧窪遞積襯窪艱) = 構遞顧糧選簾襯廠鹹繭 簾憲獵鑰鑰積積艱醖襯 (積廠膚鹽顧壓憲膚鬱鏇, 構製鹹鑰製鏇選獵糧範 ~ 壓鬱繭繭簾夢觸鹹鬱齋) 更多 | - | 2023-07-20 | |||
鹹網築網選遞網襯壓繭(壓鏇憲顧窪遞積襯窪艱) = 淵窪窪選網蓋選積鏇鏇 簾憲獵鑰鑰積積艱醖襯 (積廠膚鹽顧壓憲膚鬱鏇, 餘繭鏇鹽繭襯衊齋壓襯 ~ 觸鹹醖衊廠鬱顧構醖鏇) 更多 | |||||||
临床2期 | 局限性前列腺癌 维持 | 12 | 衊築築鹹壓築齋壓淵製(壓製鹽獵膚膚獵餘膚壓) = 築齋淵齋夢蓋憲網淵窪 觸願鹽蓋鬱築醖艱遞顧 (獵醖積鬱餘願餘製積獵 ) 更多 | 积极 | 2023-05-31 |
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