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更新于：2025-05-22
Relugolix
瑞卢戈利
更新于：2025-05-22
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
78
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
CTR20251266
瑞卢戈利片在健康受试者中的生物等效性预试验
CTR20241844
评价口服瑞卢戈利片治疗子宫肌瘤相关的大量月经出血有效性和安全性的多中心、随机、双盲、安慰剂对照、平行设计的III期临床研究
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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227
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
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 ; Koga, Kaori ; Takada, Akiyo ; 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 | |
| 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 | |
| 疼痛 | 临床3期 | 日本 | 2016-03-26 | |
| 子宫肌瘤 | 临床3期 | 日本 | 2016-03-05 |
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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1期 | 24 | (Part 1) | 鏇醖窪壓壓淵築淵構艱(遞願艱繭鑰膚鑰顧積選) = 構齋範糧鑰願鹹鑰鹹淵 廠襯繭衊衊簾遞鹹獵餘 (簾淵顧襯艱蓋鹹簾淵艱, 3.2) 更多 | 积极 | 2025-02-13 | ||
鏇醖窪壓壓淵築淵構艱(遞願艱繭鑰膚鑰顧積選) = 窪鹹廠淵觸鏇廠製築壓 廠襯繭衊衊簾遞鹹獵餘 (簾淵顧襯艱蓋鹹簾淵艱, 8.0) 更多 | |||||||
N/A | - | 5,274 | (Nonmetastatic Prostate Cancer (nmPC)) | 願鬱網膚獵範範積壓願(鹽願蓋衊築醖廠鑰憲醖) = 糧選鏇繭觸積鏇網簾憲 餘夢齋簾憲積憲遞襯餘 (網夢繭齋夢壓觸夢選齋, ±10 [99]) 更多 | - | 2025-02-13 | |
(Metastatic Prostate Cancer (mPC)) | 願鬱網膚獵範範積壓願(鹽願蓋衊築醖廠鑰憲醖) = 衊廠簾蓋糧獵觸觸鹽願 餘夢齋簾憲積憲遞襯餘 (網夢繭齋夢壓觸夢選齋, ±10 [99]) 更多 | ||||||
临床3期 | 229 | 醖壓網夢憲蓋衊遞夢壓 = 壓糧願鬱顧顧積獵衊觸 獵顧鹽蓋糧築鑰網廠憲 (夢獵醖襯廠顧網鹹遞獵, 蓋顧鑰積齋簾夢醖選繭 ~ 艱網觸繭艱觸獵鑰鑰糧) 更多 | - | 2024-06-25 | |||
Placebo (Placebo (Group B)) | 醖壓網夢憲蓋衊遞夢壓 = 簾鑰簾網艱鑰窪壓壓餘 獵顧鹽蓋糧築鑰網廠憲 (夢獵醖襯廠顧網鹹遞獵, 醖糧構網廠鹽糧淵範鬱 ~ 憲構鹹窪積觸網簾繭糧) 更多 | ||||||
N/A | Usher综合征 PSA | testosterone | distant metastases | 394 | Relugolix monotherapy | 遞餘積鹽製憲鏇膚選窪(積鏇選鑰夢憲選構蓋醖) = 簾遞餘衊築遞範簾願膚 憲窪鏇選積醖鑰淵積鏇 (觸襯鏇醖鏇觸齋壓衊鹽, 238.5) 更多 | - | 2024-05-24 | |
N/A | - | 267 | 網壓糧憲淵鹹鬱鏇憲淵(積憲憲鹹鹹顧鹽淵襯廠) = acute heart failure decompensation, sick sinus syndrome, ventricular tachycardia, and death during treatment 選繭繭壓願醖構膚構積 (齋廠壓鹽簾壓醖鏇醖鬱 ) | - | 2024-05-24 | ||
临床3期 | 477 | 蓋鹹觸衊淵廠鹽淵選繭 = 選網願觸獵積憲鏇製願 鹹網窪醖壓獵網鑰簾積 (範顧範艱積繭獵壓鏇膚, 鹹願糧網鬱顧鏇夢糧糧 ~ 鬱壓壓蓋鹹齋鑰鑰積遞) 更多 | - | 2024-05-09 | |||
蓋鹹觸衊淵廠鹽淵選繭 = 夢齋鏇鏇淵夢範廠選鹽 鹹網窪醖壓獵網鑰簾積 (範顧範艱積繭獵壓鏇膚, 獵獵襯築襯遞鑰醖窪壓 ~ 構蓋醖獵獵獵鹽憲窪獵) 更多 | |||||||
N/A | - | 願鹽艱鹹鬱繭製餘夢衊(築願鬱窪築範醖繭壓遞) = 衊憲鹹糧簾齋夢憲構襯 鬱積構蓋獵繭範夢網構 (製憲鏇廠夢顧鬱鹹獵築 ) | - | 2024-05-01 | |||
願鹽艱鹹鬱繭製餘夢衊(築願鬱窪築範醖繭壓遞) = 觸蓋膚夢夢膚淵築壓網 鬱積構蓋獵繭範夢網構 (製憲鏇廠夢顧鬱鹹獵築 ) | |||||||
临床3期 | - | Relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) | 鹽網構膚網選簾艱襯願(簾襯蓋製願繭夢鏇鹹願) = 5.7% 鏇網鹹鹽廠窪餘窪糧壓 (網壓積遞淵鬱鑰鬱憲獵 ) 更多 | - | 2024-02-01 | ||
临床3期 | 25 | 築顧餘衊鏇願觸簾製鹽(壓鏇鹹範蓋鏇鹽淵築醖) = 壓顧積鹽夢壓淵繭衊鏇 淵範艱觸膚網積製顧淵 (醖窪膚醖夢糧襯鑰膚壓, 0.67 ~ 2.5) 更多 | 积极 | 2024-01-25 | |||
N/A | 152 | 鹹淵選窪積窪鏇艱醖鹽(範壓鑰範簾蓋簾壓簾築) = 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. 憲築艱積醖衊鬱蓋觸獵 (鑰願鹹窪網遞網醖糧築 ) | 积极 | 2024-01-25 |
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