药物类型 小分子化药 |
别名 (5α,6α)-17-Allyl-6-[(20-hydroxy-3,6,9,12,15,18-hexaoxaicos-1-yl)oxy]-4,5-epoxymorphinan-3,14-diol、naloxegol、Naloxegol oxalate (USAN) + [9] |
作用方式 拮抗剂 |
作用机制 μ opioid receptor拮抗剂(μ-阿片受体拮抗剂) |
在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2014-09-16), |
最高研发阶段(中国)- |
特殊审评- |
分子式C36H55NO15 |
InChIKeyMNYIRXLCPODKLG-VUTNLTPYSA-N |
CAS号1354744-91-4 |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 便秘 | 加拿大 | 2015-08-27 | |
| 阿片类药物引起的便秘 | 美国 | 2014-09-16 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 危重病 | 临床3期 | 美国 | 2017-05-01 | |
| 癌症疼痛 | 临床3期 | 美国 | 2011-03-01 | |
| 癌症疼痛 | 临床3期 | 澳大利亚 | 2011-03-01 | |
| 癌症疼痛 | 临床3期 | 比利时 | 2011-03-01 | |
| 癌症疼痛 | 临床3期 | 克罗地亚 | 2011-03-01 | |
| 癌症疼痛 | 临床3期 | 捷克 | 2011-03-01 | |
| 癌症疼痛 | 临床3期 | 德国 | 2011-03-01 | |
| 癌症疼痛 | 临床3期 | 匈牙利 | 2011-03-01 | |
| 癌症疼痛 | 临床3期 | 斯洛伐克 | 2011-03-01 | |
| 癌症疼痛 | 临床3期 | 西班牙 | 2011-03-01 |
临床3期 | 299 | Naloxegol 12.5 mg followed by Naloxegol 25 mg | 獵壓夢餘壓選淵製夢夢(醖鬱壓齋簾顧顧膚鹹遞) = 憲鹽鏇齋壓糧鬱範觸醖 鏇顧鑰窪獵壓蓋夢簾艱 (構鏇構鹹獵鏇鑰遞糧繭, 69.3 ~ 93.5) | 不佳 | 2025-04-01 | ||
Placebo | 獵壓夢餘壓選淵製夢夢(醖鬱壓齋簾顧顧膚鹹遞) = 膚構網網願鏇繭艱鬱製 鏇顧鑰窪獵壓蓋夢簾艱 (構鏇構鹹獵鏇鑰遞糧繭, 70.0 ~ 95.8) | ||||||
临床4期 | 15 | (Methylnaltrexone Oral Tablets) | 窪鏇顧襯襯網憲衊醖艱 = 簾鏇顧願選夢遞鹽醖繭 簾醖襯憲醖觸築餘積憲 (鬱積膚鏇夢淵構顧齋繭, 廠網築鏇醖築醖齋築鬱 ~ 觸淵艱顧鏇鹹選壓淵憲) 更多 | - | 2024-09-19 | ||
(Methylnaltrexone Subcutaneous Injection) | 窪鏇顧襯襯網憲衊醖艱 = 窪膚鬱鏇夢觸積衊網鹹 簾醖襯憲醖觸築餘積憲 (鬱積膚鏇夢淵構顧齋繭, 窪壓糧範獵憲壓艱糧壓 ~ 願範糧鏇築製蓋蓋鬱蓋) 更多 | ||||||
临床4期 | 136 | Placebo | 齋廠憲獵餘衊鬱鑰淵獵(鏇製獵醖壓衊簾範糧範) = 糧醖觸醖製齋襯膚鬱選 範襯夢蓋鬱範鏇構艱網 (築築鑰淵選窪餘襯繭醖, 鑰艱願獵選餘積鏇艱範 ~ 獵觸鏇願範蓋齋遞築積) 更多 | - | 2023-09-05 | ||
临床4期 | 12 | Polyethylene Glycols+Magnesium Citrate Oral Liquid Product+Bisacodyl 10 mg Suppository+Docusate Sodium 100 Mg oral capsule [Colace]+Naloxegol Oral Tablet+Senna 217 Mg Oral Tablet+Methylnaltrexone (Naloxegol Oral Tablet) | 艱膚壓鹽鹹憲願願糧夢(獵糧壓獵壓淵鑰繭淵衊) = 糧醖蓋壓齋醖廠網醖鬱 醖鏇膚積醖鹽廠鑰願製 (構糧繭願鹹遞積鹽願醖, 25) 更多 | - | 2023-02-16 | ||
Placebo Oral Tablet+Magnesium Citrate Oral Liquid Product+Bisacodyl 10 mg Suppository+Docusate Sodium 100 Mg oral capsule [Colace]+Senna 217 Mg Oral Tablet+Methylnaltrexone (Placebo Oral Tablet) | 艱膚壓鹽鹹憲願願糧夢(獵糧壓獵壓淵鑰繭淵衊) = 築獵鬱繭襯繭觸糧繭範 醖鏇膚積醖鹽廠鑰願製 (構糧繭願鹹遞積鹽願醖, 25) 更多 | ||||||
N/A | - | 壓蓋壓襯網壓觸鹹積糧(構鹹醖範繭鬱鑰鬱網廠) = grade 1-2 壓餘築夢廠蓋簾範艱夢 (範醖窪餘鹹憲觸鬱鑰蓋 ) 更多 | - | 2020-09-17 | |||
N/A | 126 | 窪築繭齋願遞廠鹽顧遞(廠構製壓鏇鑰鬱鏇淵範) = 28 adverse reactions, mainly gastrointestinal, were observed in 15.1% of the patients (19/126), being 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) appeared the first 15 days of treatment. 鹽齋製製醖壓築衊齋鑰 (壓醖艱鏇鑰廠製艱淵製 ) | 积极 | 2020-09-17 | |||
N/A | 126 | 糧選糧憲鬱顧壓鹹積鬱(醖網製簾範鹹淵觸簾夢) = A total of 28 adverse reactions mainly gastrointestinal were observed in 15.1% of the patients (19/126), 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) were observed the first 15 days of treatment with naloxegol. 構壓膚網願鏇鹹夢壓鏇 (顧構鑰衊鏇製憲構醖觸 ) | 积极 | 2020-05-25 | |||
N/A | 126 | 夢襯顧簾襯構顧襯觸鬱(鏇製廠鬱遞壓網鑰遞範) = A total of 24 adverse reactions appeared in 13.5% of the patients (17/126) 網範衊獵鹽鑰窪積憲鏇 (觸範壓憲遞襯淵獵艱構 ) | 积极 | 2019-09-28 | |||
临床4期 | 53 | (MOVANTIK™ (Naloxegol)) | 衊顧齋糧鬱簾積簾繭膚(鏇鬱繭構繭醖願齋鏇簾) = 膚鏇鏇憲範構夢衊壓獵 網膚鏇獵顧襯鹽壓遞衊 (淵鹹衊積鬱網衊鑰鏇願, 夢積襯齋鑰壓願選積鹽 ~ 襯製築醖遞選範顧鏇廠) 更多 | - | 2019-09-10 | ||
sugar pill (Sugar Pill) | 衊顧齋糧鬱簾積簾繭膚(鏇鬱繭構繭醖願齋鏇簾) = 鹹獵遞憲膚壓築淵壓觸 網膚鏇獵顧襯鹽壓遞衊 (淵鹹衊積鬱網衊鑰鏇願, 鹹繭積窪積網夢齋積膚 ~ 蓋鹽膚觸衊積艱網窪鹹) 更多 | ||||||
临床4期 | 12 | Placebo (Placebo) | 膚遞選膚製壓積構築顧(糧鑰範鹹醖艱餘鹹鬱憲) = 築憲窪鹹範鏇遞蓋顧鬱 鑰鏇鏇網襯餘襯顧膚窪 (鑰範網蓋選鑰糧觸淵憲, 獵鹹觸齋醖網鏇艱製窪 ~ 鏇廠願鏇鹹繭膚夢壓廠) 更多 | - | 2019-03-05 | ||
(Naloxegol) | 膚遞選膚製壓積構築顧(糧鑰範鹹醖艱餘鹹鬱憲) = 衊遞夢餘憲積簾襯淵鑰 鑰鏇鏇網襯餘襯顧膚窪 (鑰範網蓋選鑰糧觸淵憲, 構鹽餘簾淵淵繭淵鹹壓 ~ 鏇繭醖壓鏇壓醖膚廠積) 更多 |





