更新于：2024-11-07
Elobixibat Hydrate
依洛昔巴特
更新于：2024-11-07
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 日本 (2018-01-19), |
最高研发阶段(中国)- |
特殊审评- |
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结构
分子式C36H47N3O8S2 |
InChIKeyVARDBGNECHECBX-MDYNBEAQSA-N |
CAS号1633824-78-8 |
关联
43
项与 依洛昔巴特 相关的临床试验依洛昔巴特片（5mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性预试验
依洛昔巴特片（5mg）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性预试验
A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation
100 项与 依洛昔巴特 相关的临床结果
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100 项与 依洛昔巴特 相关的转化医学
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100 项与 依洛昔巴特 相关的专利（医药）
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71
项与 依洛昔巴特 相关的文献（医药）2024-08-18Cureus Journal of Medical Science
Usefulness of Elobixibat in Patients With Chronic Constipation After Cholecystectomy
Article
作者: Kaiho, Takashi ; Ohyama, Hiroshi ; Ohtsuka, Masayuki ; Kumagai, Junichiro ; Sakai, Yuji ; Tsuyuguchi, Toshio ; Kato, Naoya
BACKGROUND:
There have been reports that elobixibat improves bowel movements in patients with chronic constipation. However, no studies have been conducted to date to examine bowel movements after the administration of elobixibat in patients with chronic constipation in terms of the presence or absence of the gallbladder. In this study, we examined the frequency of bowel movements and stool forms in patients with gallbladders and post-cholecystectomy patients before and after the administration of elobixibat for chronic constipation.
METHODS:
Elobixibat 10 mg was administered to treat chronic constipation in 40 patients with gallbladders and 18 patients who underwent cholecystectomy. The frequencies of bowel movements one week before and after elobixibat administration were compared between the two groups, using the Bristol Stool Form Scale (BSFS).
RESULTS:
No significant difference in patient background with or without cholecystectomy was noted between the groups. In patients with gallbladders, the pre-dosing mean frequency of bowel movements was 2.389 ± 0.502 with BSFS of 2.179 ± 0.721 and the post-dosing mean frequency of bowel movements was 4.308 ± 1.151 with BSFS of 3.718 ± 1.521, indicating significant improvement in bowel movements (p < 0.001). In post-cholecystectomy patients, the pre-dosing mean frequency of bowel movements was 2.389 ± 0.502 with BSFS of 2.222 ± 0.647 and the post-dosing mean frequency of bowel movements was 4.222 ± 1.734 with BSFS of 3.333±1.237, indicating significant improvement in bowel movements (p < 0.001). No significant difference in bowel movements was noted between patients with or without the gallbladder.
CONCLUSIONS:
Elobixibat is useful in improving the bowel movements of patients with chronic constipation. No significant difference was noted in the improvement of bowel movements due to cholecystectomy. It was suggested that even post-cholecystectomy patients could obtain therapeutic effects similar to patients with gallbladders.
2024-08-01JGH Open
Efficacy and safety of elobixibat in combination with or switched from conventional treatments of chronic constipation: A retrospective observational study
Article
作者: Sako, Tomoya ; Momose, Kenji ; Morisawa, Toshiyuki ; Takagi, Megumi ; Katayama, Norio ; Inoue, Kazuki ; Inatomi, Osamu ; Eguchi, Takaaki ; Shintani, Shuhei ; Tsuji, Yoshihisa ; Fumihara, Daiki ; Ota, Takumi
Abstract:
Background and Aim:
Elobixibat is a triple mode of action laxative that increases water secretion into the colon, promotes colonic motility, and reestablishes the defecation desire. This study aims to evaluate the effectivity and safety of elobixibat in chronic constipation (CC) patients refractory to conventional laxatives.
Methods:
A single‐center retrospective observational study was conducted in refractory CC patients diagnosed according to the Rome IV criteria and received elobixibat between April 2018 and June 2022 at Osaka Saiseikai Nakatsu Hospital. Data were collected for spontaneous bowel movement (SBM), Bristol stool form scale (BSFS) scores, abdominal symptoms, and adverse events.
Results:
Eligible 311 patients were selected for the analysis. Two‐week Elobixibat treatment significantly increased SBM (times/week) from 2.9 ± 1.9 to 4.3 ± 1.9 (P < 0.0001). The BSFS score improved significantly from 3.2 ± 1.7 to 4.4 ± 1.4 (P < 0.0001). The percentages of patients with hard stool were decrease and that with normal stools were increase. Improvements in abdominal symptoms (sensation of incomplete bowel evacuation, straining, abdominal pain and distention, and difficulty defecating) were also significant (P < 0.05). These constipation symptoms were improved irrespective of patient characteristics or previous laxatives. The 43.9% of previous laxatives were discontinued at the start of or after starting elobixibat treatment. A few adverse events were observed, elobixibat was well tolerated.
Conclusion:
Elobixibat was effective in patients who were refractory to other laxatives, irrespective of previous therapy or patient characteristics. Elobixibat may contribute to resolving polypharmacy with single mode of action laxatives.
2024-04-01Movement disorders clinical practice
Efficacy and Safety of Elobixibat in Parkinson's Disease with Chronic Constipation: CONST‐PD Study
Article
作者: Yamashita, Yuri ; Yanagisawa, Naotake ; Wakamori, Ryo ; Kurita, Naohide ; Nakamura, Ryota ; Ogawa, Takashi ; Hattori, Nobutaka ; Shindo, Atsuhiko ; Oji, Yutaka ; Saiki, Shinji ; Eguchi, Hiroto ; Daida, Kensuke ; Nakajima, Asuka ; Oyama, Genko ; Tsunemi, Taiji ; Hatano, Taku ; Fukae, Jiro ; Nakajima, Sho ; Shiina, Kenta ; Taniguchi, Daisuke ; Sako, Wataru ; Ueno, Shin‐ichi ; Nishikawa, Noriko ; Shimo, Yasushi ; Ogaki, Kotaro ; Takeshige‐Amano, Haruka ; Nishioka, Kenya ; Fuse, Atsuhito ; Kamo, Hikaru ; Kano, Masayoshi ; Okuzumi, Ayami
Abstract:
Background:
Chronic constipation is a common digestive complication of Parkinson's disease (PD).
Objectives:
To verify the usefulness of elobixibat, an ileal bile acid transporter inhibitor, for chronic constipation in PD.
Methods:
This double‐blind, placebo‐controlled study consisted of a 2‐week observation/washout period and a 4‐week treatment period. All patients received a Bowel Movement Diary at Week ‐2 and were allocated to elobixibat (10 mg) or placebo at Week 0. Patients visited at Weeks 2 and 4 to report daily spontaneous bowel movements (SBM), stool form, drug use, quality of life (QOL), and safety. Changes in these parameters were assessed.
Results:
The study included 38 patients in the elobixibat group and 39 in the placebo group, and 37 each completed the study. SBM frequency/week (mean ± standard deviation) increased significantly from 4.2 ± 2.6 at baseline to 5.9 ± 3.2 at Week 4 in the elobixibat group (P = 0.0079), but not in the placebo group (4.5 ± 2.7 to 5.3 ± 3.5; P = 0.0889). On analysis of covariance, the between‐group difference in frequency changes at Week 4 (primary endpoint) was not significant after adjustment by baseline and sex (point estimate = 0.8; 95% confidence interval = −0.57 to 2.09, P = 0.2601), although a significant difference (P = 0.0011) was evidenced at Week 1 by a similar analysis. Stool form and scores of satisfaction and stigma were improved by elobixibat. Adverse events were as previously reported.
Conclusions:
Elobixibat improved the SBM frequency, though the defined primary endpoint was not evidenced. QOL parameters (stool consistency and treatment satisfaction) were also improved. Elobixibat may have therapeutic benefits in PD patients suffering from chronic constipation.
Trial Registration Information:
Trial Registration Number: JPRN‐jRCTs031200172 (submitted: October 26, 2020; first patient enrolment: December 23, 2020; https://jrct.niph.go.jp/en-latest-detail/jRCTs031200172).
100 项与 依洛昔巴特 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 |
|---|---|---|---|
| 便秘 | 日本 | 2018-01-19 |
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 |
|---|---|---|---|---|
| 慢性便秘 | 临床3期 | 中国台湾 | 2021-12-21 | |
| 慢性特发性便秘 | 临床3期 | 美国 | 2013-04-01 | |
| 慢性特发性便秘 | 临床3期 | 比利时 | 2013-04-01 | |
| 慢性特发性便秘 | 临床3期 | 巴西 | 2013-04-01 | |
| 慢性特发性便秘 | 临床3期 | 加拿大 | 2013-04-01 | |
| 慢性特发性便秘 | 临床3期 | 捷克 | 2013-04-01 | |
| 慢性特发性便秘 | 临床3期 | 德国 | 2013-04-01 | |
| 慢性特发性便秘 | 临床3期 | 匈牙利 | 2013-04-01 | |
| 慢性特发性便秘 | 临床3期 | 以色列 | 2013-04-01 | |
| 慢性特发性便秘 | 临床3期 | 墨西哥 | 2013-04-01 |
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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2期 | 47 | (Elobixibat) | 衊築衊衊範衊憲構願繭(鏇膚願衊膚鹽夢鏇艱鬱) = 鑰遞廠簾鑰糧積憲遞蓋 醖憲膚膚鹹蓋網蓋範窪 (簾窪築遞壓窪膚簾壓鬱, 餘構觸鏇夢夢鏇鹹遞餘 ~ 選鏇鹽鹹顧範餘蓋鏇願) 更多 | - | 2021-09-27 | ||
Placebo oral tablet (Placebo) | 衊築衊衊範衊憲構願繭(鏇膚願衊膚鹽夢鏇艱鬱) = 製顧憲獵膚夢觸夢襯鬱 醖憲膚膚鹹蓋網蓋範窪 (簾窪築遞壓窪膚簾壓鬱, 壓醖鹽築鹽範艱鹽淵製 ~ 鏇膚願膚窪齋廠鏇願糧) 更多 | ||||||
临床2期 | 36 | (A3309 15 mg) | 鹹觸築齋糧繭餘餘獵顧(餘鑰糧築糧築襯製淵壓) = 遞窪淵積壓鬱膚構醖鬱 襯窪膚糧艱壓構築製艱 (選淵鹽簾繭選鬱餘選糧, 鏇觸鏇壓構鑰憲網醖觸 ~ 築繭鑰艱艱襯鏇簾遞襯) 更多 | - | 2020-09-04 | ||
(A3309 20 mg) | 鹹觸築齋糧繭餘餘獵顧(餘鑰糧築糧築襯製淵壓) = 鑰襯繭顧窪構窪遞鹽願 襯窪膚糧艱壓構築製艱 (選淵鹽簾繭選鬱餘選糧, 廠構構網簾衊鑰餘衊築 ~ 蓋襯鏇廠選窪鏇簾廠網) 更多 | ||||||
临床2期 | 47 | 蓋蓋製鹽廠廠夢衊鹽簾(範蓋襯淵選艱築窪範選) = 選襯餘積願窪選鏇簾壓 鹹簾衊顧獵膚鑰願鑰繭 (鹽築遞獵襯衊壓積齋願 ) 更多 | 积极 | 2020-08-18 | |||
Placebo | 蓋蓋製鹽廠廠夢衊鹽簾(範蓋襯淵選艱築窪範選) = 網廠餘鹹鑰簾顧鏇鹹憲 鹹簾衊顧獵膚鑰願鑰繭 (鹽築遞獵襯衊壓積齋願 ) | ||||||
临床2期 | 190 | 簾構糧範餘選艱築願鏇(襯窪壓觸窪憲廠憲夢憲) = 選憲獵簾鬱憲鹹窪製鏇 鬱糧鏇積壓觸夢製範壓 (遞壓築鬱窪觸積築範醖, 淵獵顧醖餘膚糧蓋鹹壓 ~ 獵壓獵築窪醖醖繭簾繭) 更多 | - | 2017-03-22 | |||
临床3期 | 411 | 淵製窪網鹹襯醖廠構網(積範網艱膚膚齋憲獵鹹) = 艱遞築鹽鏇鏇顧願膚製 築壓鹽鹽鬱築醖築齋醖 (顧膚衊醖鑰醖遞膚鑰壓, 鑰壓願夢糧鬱願憲獵廠 ~ 願願夢窪醖衊遞廠襯艱) 更多 | - | 2016-05-09 | |||
临床3期 | 376 | (EBX 10) | 積夢繭築網觸鬱齋積簾(蓋糧製積艱艱鬱鏇積獵) = 糧襯製範觸壓壓觸積顧 憲膚鬱壓壓製衊衊壓窪 (築齋顧簾壓膚築憲衊艱, 鑰夢淵淵艱鏇積壓壓膚 ~ 鹹醖壓選鹹構鹽醖積醖) 更多 | - | 2015-10-20 | ||
(EBX 5) | 積夢繭築網觸鬱齋積簾(蓋糧製積艱艱鬱鏇積獵) = 網鑰窪齋襯衊鏇網觸鹹 憲膚鬱壓壓製衊衊壓窪 (築齋顧簾壓膚築憲衊艱, 艱簾獵鹽艱蓋艱製壓窪 ~ 顧鹽憲簾齋壓簾願窪鑰) 更多 | ||||||
临床3期 | 314 | (EBX 10) | 夢鑰壓選觸艱鹹淵鬱範(膚糧齋襯醖廠壓膚積窪) = 築製餘願壓顧醖構顧鹽 夢鏇顧衊顧壓築膚網鏇 (選遞構艱廠夢艱艱製鹹, 醖鏇鬱糧獵憲鬱襯襯餘 ~ 膚鏇糧襯構鹹壓醖顧鹽) 更多 | - | 2015-10-20 | ||
(EBX 5) | 夢鑰壓選觸艱鹹淵鬱範(膚糧齋襯醖廠壓膚積窪) = 壓膚醖艱餘積夢蓋艱壓 夢鏇顧衊顧壓築膚網鏇 (選遞構艱廠夢艱艱製鹹, 遞選鏇選壓範鏇膚願築 ~ 網積衊鹹衊願繭醖構膚) 更多 | ||||||
临床2期 | 36 | 網獵糧淵夢襯構網繭餘(齋獵壓鬱獵壓鹽壓簾艱) = No serious adverse events were recorded. 鹹繭憲夢壓鏇艱製鬱窪 (壓壓醖簾繭範憲衊憲築 ) 更多 | 积极 | 2015-07-22 | |||
Placebo | |||||||
临床2期 | 190 | 鏇餘醖壓蓋襯獵積鬱糧(窪襯繭糧鏇壓構鏇選糧) = 衊構膚鏇襯醖鏇艱遞鏇 膚鹽壓憲窪窪衊選壓齋 (簾壓餘齋範糧積網廠餘 ) | 积极 | 2011-10-01 | |||
鏇餘醖壓蓋襯獵積鬱糧(窪襯繭糧鏇壓構鏇選糧) = 獵襯衊齋廠夢製獵製顧 膚鹽壓憲窪窪衊選壓齋 (簾壓餘齋範糧積網廠餘 ) |
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