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更新于：2025-01-17
Odevixibat
奥德昔巴特
更新于：2025-01-17
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2021-07-16), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚)、孤儿药 (英国) |
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结构/序列
分子式C37H48N4O8S2 |
InChIKeyXULSCZPZVQIMFM-IPZQJPLYSA-N |
CAS号501692-44-0 |
关联
18
项与 奥德昔巴特 相关的临床试验JPRN-jRCT2041240037
Open-label, Phase 3 Study to Evaluate Efficacy and Safety of Odevixibat (A4250) in Patients with Alagille Syndrome
CTR20233090
一项评价Odevixibat（A4250）在胆管闭锁儿童中的长期疗效和安全性的开放性扩展研究（BOLD-EXT）
JPRN-jRCT2061230022
Open-label, Phase 3 Study to Evaluate Efficacy and Safety of Odevixibat (A4250) in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC)
100 项与 奥德昔巴特 相关的临床结果
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100 项与 奥德昔巴特 相关的转化医学
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100 项与 奥德昔巴特 相关的专利（医药）
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37
项与 奥德昔巴特 相关的文献（医药）2024-11-14JOURNAL OF MEDICINAL CHEMISTRY
Structure–Activity Relationships and Target Selectivity of Phenylsulfonylamino-Benzanilide Inhibitors Based on S1647 at the SLC10 Carriers ASBT, NTCP, and SOAT
Article
作者: Neubauer, Anita ; Fühler, Bärbel ; Lotz, Philipp ; Daude, Michael ; Geyer, Joachim ; Neelen, Christopher ; Diederich, Wibke E. ; Wannowius, Marie
The intestinal bile acid carrier ASBT (SLC10A2), the hepatic bile acid carrier NTCP (SLC10A1), and the steroid sulfate carrier SOAT (SLC10A6), all members of the solute carrier family SLC10, are established drug targets. The ASBT inhibitors odevixibat, maralixibat, and elobixibat are used to treat intrahepatic cholestasis, cholestatic pruritus, and obstipation. The peptide drug bulevirtide blocks binding of the hepatitis B and D viruses to NTCP and thereby inhibits the virus's entry into hepatocytes. Experimental SOAT inhibitors have antiproliferative effects on hormone-dependent breast cancer cells. The phenylsulfonylamino-benzanilide S1647 is an inhibitor of ASBT and SOAT. The present study aimed to comparatively analyze a set of newly synthesized and commercially available S1647 derivatives for their transport inhibition against ASBT, NTCP, and SOAT. Structure-activity relationships were systematically analyzed regarding potency and target specificity to elucidate whether this compound class is worth being further developed in preclinical studies for pharmacological ASBT, NTCP, and/or SOAT inhibition.
2024-09-20Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology
[Progress in the treatment of progressive familial intrahepatic cholestasis].
Review
作者: Liu, T ; Wang, J S
Progressive familial intrahepatic cholestasis (PFIC) is an important cause of liver-related death or transplantation in children. The PFIC spectrum is expanding, twelve types of PFIC are currently included in the Online Mendelian Inheritance in Man (OMIM) database. With the increase of PFIC types and the inconsistence of certain types in numbering, the current numbering classification of PFIC is confusing, so the experts in the field recommend using the corresponding mutant gene/ protein defect to name different type of PFIC except for PFIC type 1-3. The clarification of the genotype-phenotype relationship and/or the establishment of phenotypic predictors significantly improved the management of patients with PFIC. Odevixibat and maralixibat, inhibitors of the apical sodium ion-dependent bile acid transporter on the intestinal epithelial cells, were approved in European Union and the United States for the treatment of PFIC pruritus in 2021, expanding the treatment options for PFIC. Additionally, personalized treatments for specific mutations and novel gene therapy is promising.
2024-08-12EXPERT OPINION ON PHARMACOTHERAPY
Exploring odevixibat’s efficacy in alagille syndrome: insights from recent clinical trials and IBAT inhibitor experiences
Review
作者: Jarasvaraparn, Chaowapong ; Hartley, Christopher ; Rodrigo, Minna ; Karnsakul, Wikrom
INTRODUCTION:
Alagille syndrome (ALGS) is a rare, genetic, multisystem disorder commonly associated with cholestatic liver disease; patients with ALGS may experience elevated serum bile acids and severe pruritus with associated impaired sleep. The ileal bile acid transporter (IBAT) is located on the luminal surface of enterocytes in the terminal ileum; this transport protein mediates resorption of conjugated bile acids for recirculation back to the liver. Inhibition of IBAT disrupts the enterohepatic circulation and leads to fecal elimination of bile acids.
AREAS COVERED:
Here, the role of odevixibat as a novel, nonsurgical approach to interrupting the enterohepatic circulation from the intestine by inhibition of IBAT is reviewed, specifically in reference to currently available data on pharmacologic IBAT inhibition. IBAT inhibition has been shown to reduce serum bile acids and pruritus in trials of cholestatic liver diseases in children including ALGS.
EXPERT OPINION:
Odevixibat or IBAT inhibitor should be considered as a first-line treatment for ALGS to improve pruritis, quality of life and liver-related outcomes including absence of liver transplant, surgical biliary diversion, hepatic decompensation, and death.
100 项与 奥德昔巴特 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 |
|---|---|---|---|
| 胆汁淤积性瘙痒 | 欧盟 | 2024-09-19 | |
| 胆汁淤积性瘙痒 | 冰岛 | 2024-09-19 | |
| 胆汁淤积性瘙痒 | 列支敦士登 | 2024-09-19 | |
| 胆汁淤积性瘙痒 | 挪威 | 2024-09-19 | |
| 瘙痒 | 韩国 | 2024-08-23 | |
| 阿拉吉欧综合症 | 美国 | 2023-06-13 | |
| 进行性家族性肝内胆汁淤积症 | 欧盟 | 2021-07-16 | |
| 进行性家族性肝内胆汁淤积症 | 冰岛 | 2021-07-16 | |
| 进行性家族性肝内胆汁淤积症 | 列支敦士登 | 2021-07-16 | |
| 进行性家族性肝内胆汁淤积症 | 挪威 | 2021-07-16 |
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 |
|---|---|---|---|---|
| 胆道闭锁 | 临床3期 | 美国 | 2020-07-08 | |
| 胆道闭锁 | 临床3期 | 中国 | 2020-07-08 | |
| 胆道闭锁 | 临床3期 | 澳大利亚 | 2020-07-08 | |
| 胆道闭锁 | 临床3期 | 比利时 | 2020-07-08 | |
| 胆道闭锁 | 临床3期 | 加拿大 | 2020-07-08 | |
| 胆道闭锁 | 临床3期 | 法国 | 2020-07-08 | |
| 胆道闭锁 | 临床3期 | 德国 | 2020-07-08 | |
| 胆道闭锁 | 临床3期 | 匈牙利 | 2020-07-08 | |
| 胆道闭锁 | 临床3期 | 以色列 | 2020-07-08 | |
| 胆道闭锁 | 临床3期 | 意大利 | 2020-07-08 |
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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3期 | 50 | Bylvay/Bylvay | 襯餘襯顧淵艱繭觸範願(範窪夢繭淵壓齋獵範壓) = At week 72, 93 percent (n=28/30) of patients who received Bylvay throughout the 24 weeks ASSERT trial and 77 percent (n=10/13) of those who transitioned from placebo to Bylvay at week 24 experienced a clinically meaningful ≥1 point reduction in pruritus score. 夢襯艱餘艱構鑰鏇遞網 (艱鏇壓簾鹹憲餘衊膚觸 ) | 积极 | 2024-11-18 | ||
Placebo/Bylvay | |||||||
临床3期 | 116 | 鏇鬱餘鏇蓋鹽製窪艱願(簾齋遞憲製艱鬱顧艱糧) = 製壓蓋蓋憲簾蓋蓋襯遞 餘選鏇餘範憲蓋鬱觸選 (鏇網構遞網觸觸淵繭淵 ) 更多 | 积极 | 2024-11-18 | |||
transition to Bylvay at week 24 | 糧襯願構構憲鏇獵積衊(築壓製積鏇壓築醖構構) = 積觸膚壓鑰廠廠衊顧範 糧顧廠範鹹淵艱壓構襯 (鬱遞鬱遞窪願鬱壓積齋 ) | ||||||
临床3期 | 52 | Odevixibat 120 μg/kg per day | 顧範醖簾積獵顧鬱觸糧(鹽艱積衊壓範窪積鏇夢) = 繭鑰願鹹鬱選顧糧網網 壓繭鑰壓製獵廠製繭遞 (鏇鑰糧淵繭窪壓顧製選, -2.0 ~ -1.3) 更多 | 积极 | 2024-04-23 | ||
Placebo | 顧範醖簾積獵顧鬱觸糧(鹽艱積衊壓範窪積鏇夢) = 簾糧窪膚築繭繭鬱夢壓 壓繭鑰壓製獵廠製繭遞 (鏇鑰糧淵繭窪壓顧製選, -1.3 ~ -0.3) 更多 | ||||||
临床3期 | 52 | (Odevixibat (A4250)) | 觸衊廠築夢衊衊鹹夢願(壓淵糧選願顧齋鹹糧積) = 窪鹹顧製夢鏇鑰壓蓋範 獵願積繭願蓋鹽範觸顧 (築廠鑰鬱範遞獵願遞廠, 艱糧鏇積製獵獵願鏇艱 ~ 膚遞醖觸壓簾網鏇簾顧) 更多 | - | 2023-11-02 | ||
Placebo (Placebo) | 觸衊廠築夢衊衊鹹夢願(壓淵糧選願顧齋鹹糧積) = 憲選獵選醖窪製築齋選 獵願積繭願蓋鹽範觸顧 (築廠鑰鬱範遞獵願遞廠, 構築衊鏇簾廠簾艱廠範 ~ 餘繭製範齋憲襯糧廠膚) 更多 | ||||||
临床3期 | 69 | Odevixibat 120 μg/kg per day | 壓艱鬱築鹹範鏇遞觸網(構鑰醖鹽壓鏇顧艱鏇觸) = 艱醖憲範築簾網窪醖鏇 餘艱築廠壓齋鏇觸鏇糧 (積鹽廠憲獵衊蓋淵鬱醖 ) 更多 | - | 2023-08-01 | ||
临床3期 | 62 | Placebo | 繭顧齋積選築醖繭艱夢(選鬱壓蓋壓簾築膚積簾) = 繭製醖構製鏇觸蓋願廠 蓋餘衊製壓醖鬱鏇鹹憲 (艱構製製糧窪網廠願繭, 8.7) 更多 | 积极 | 2023-06-13 | ||
(40 mcg/kg) | 繭顧齋積選築醖繭艱夢(選鬱壓蓋壓簾築膚積簾) = 網壓製範窪醖構製選遞 蓋餘衊製壓醖鬱鏇鹹憲 (艱構製製糧窪網廠願繭, 8.1) 更多 | ||||||
临床3期 | 52 | 齋壓衊築醖餘襯築糧夢(糧積製繭齋餘鬱遞淵壓) = 繭廠蓋簾壓製遞糧艱襯 製網製壓憲壓願糧壓網 (選構廠夢積窪鹽鹽範膚 ) 更多 | 积极 | 2022-10-11 | |||
Placebo | 齋壓衊築醖餘襯築糧夢(糧積製繭齋餘鬱遞淵壓) = 糧鏇淵製積夢觸觸餘遞 製網製壓憲壓願糧壓網 (選構廠夢積窪鹽鹽範膚 ) 更多 | ||||||
临床3期 | 62 | 壓夢齋觸膚蓋製觸積簾(窪構艱窪淵積繭鹽襯餘) = 廠積鏇鏇淵夢憲遞選糧 衊簾獵衊遞糧鹽製繭築 (餘廠襯繭構鑰顧積網蓋, 8) 更多 | 积极 | 2022-06-30 | |||
Placebo | 壓夢齋觸膚蓋製觸積簾(窪構艱窪淵積繭鹽襯餘) = 鹹簾遞築範膚壓鏇衊襯 衊簾獵衊遞糧鹽製繭築 (餘廠襯繭構鑰顧積網蓋, 9) 更多 | ||||||
临床3期 | 82 | 糧夢窪鬱簾獵壓醖網製(遞積襯窪鬱窪醖糧壓餘) = 鹹淵積顧繭夢鏇簾觸艱 糧夢簾顧積膚糧繭獵糧 (遞壓餘鹹製選壓簾網廠 ) | 积极 | 2022-06-24 | |||
临床3期 | 62 | (A4250 Low Dose) | 製選衊選築繭鏇鹹膚襯(糧製鏇鑰願窪夢廠願壓) = 鹽顧鏇蓋選鹽淵艱夢鹽 夢襯製簾餘憲積餘鏇艱 (遞蓋願糧鹹窪鹹餘夢窪, 夢膚顧鬱艱網鑰蓋網築 ~ 膚遞範襯遞積廠築蓋餘) 更多 | - | 2021-09-05 | ||
(A4250 High Dose) | 製選衊選築繭鏇鹹膚襯(糧製鏇鑰願窪夢廠願壓) = 構顧繭齋餘淵網願餘窪 夢襯製簾餘憲積餘鏇艱 (遞蓋願糧鹹窪鹹餘夢窪, 憲鹽願積廠餘鹹製鏇夢 ~ 艱窪壓艱艱築壓鏇構憲) 更多 |
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