A Phase I, Randomized, Open-label, Single Dose, 2 Period, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Linerixibat Tablets in Healthy Adult Participants

This study will evaluate the effect of food on the Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters of linerixibat administered in fed and fasted states in heathy adult participants

开始日期2022-08-11

申办/合作机构

GSK Plc

NCT05393076

/ Completed临床1期

A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Matched Control Participants

This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function. All participants in both cohorts (moderate hepatic impairment and matched healthy controls) will receive a single dose of the study drug, linerixibat. The purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) and safety of linerixibat.

开始日期2022-07-19

申办/合作机构

GSK Plc

NCT05133830

/ Completed临床1期

A Two-part, Phase 1, Open-label, Randomized, Parallel-arm, Fixed Sequence, Drug-drug Interaction Study to Investigate the Effect of Linerixibat on Plasma Concentrations of Obeticholic Acid and Conjugates in Healthy Adult Participants

This study aims to investigate the effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and its conjugates in healthy adult participants to inform the potential for drug interaction with coadministration of linerixibat and OCA.

开始日期2021-11-23

申办/合作机构

GSK Plc

100 项与利奈昔巴特相关的临床结果

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100 项与利奈昔巴特相关的转化医学

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100 项与利奈昔巴特相关的专利（医药）

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项与利奈昔巴特相关的文献（医药）

2025-03-01·CPT-Pharmacometrics & Systems Pharmacology

Analysis of C4 Concentrations to Predict Impact of Patient‐Reported Diarrhea Associated With the Ileal Bile Acid Transporter Inhibitor Linerixibat

Article

作者: Carreño, Fernando ; Swift, Brandon ; Collins, Jon ; de Souza, Andrea Ribeiro ; Mehta, Rashmi

ABSTRACT:

Linerixibat, an ileal bile acid transporter (IBAT) inhibitor, is being evaluated for the treatment of pruritus in primary biliary cholangitis (PBC). Diarrhea is commonly reported with this drug class as IBAT inhibition redirects bile acids (BA) to the colon. Serum 7‐alpha‐hydroxy‐4‐cholesten‐3‐one (C4) measurement is a validated method to identify BA diarrhea. To inform dose selection, we characterized the relationship between linerixibat dose, C4 levels, and patient‐reported bother on the gastrointestinal symptom rating scale (GSRS) diarrhea question. A kinetic‐pharmacodynamic model was developed using data from five Phase 1/2 trials, to describe the effect of linerixibat dose (1–180 mg) and regimen (once/twice daily) on C4 concentrations over time. GSRS data from patients with PBC and pruritus in the Phase 2b GLIMMER study (NCT02966834) were used to develop a proportional odds model to predict the probability of a score of 1–7 (no–very severe discomfort) to the question “Have you been bothered by diarrhea during the past week?” in relation to linerixibat dose. The two models were linked to describe the linerixibat dose‐C4‐diarrhea bother relationship. Models were validated using graphical and numerical assessment and visual predictive checks. Linerixibat caused dose‐dependent increases in C4 until saturation (~180 mg total daily dose). Increased C4 concentrations trended with increased GSRS diarrhea scores. Simulations demonstrated increases in moderate‐to‐very severe (≥ 4) diarrhea scores with increasing linerixibat dose. Increases in patient‐reported diarrhea scores were linerixibat dose‐dependent. Selecting an optimal dose that maximizes linerixibat's ability to improve pruritus while minimizing patient‐reported diarrhea bother is important to support treatment adherence.

2024-10-01·BIOMEDICINE & PHARMACOTHERAPY

Studies on absorption mechanism and pharmacokinetic properties of albendazole-bile acid conjugate: In vivo and in vitro

Article

作者: Tang, Shizhen ; Liu, Jingshuai ; Guo, Zhimei ; Nie, Kaili ; Hu, Chunhui

PURPOSE:

To improve the oral bioavailability of albendazole (ABZ), a series of albendazole-bile acid conjugates (ABCs) were synthesized. ABC's transmembrane transport mechanism and in vivo pharmacokinetic properties were preliminarily studied.

METHODS:

The transmembrane transport mechanism of ABCs was studied using the Caco-2 monolayer cell model and intestinal perfusion model. The concentration of ABCs and ABZ were evaluated using High-Performance Liquid Chromatography (HPLC) and HPLC-Mass Spectrometry (HPLC-MS/MS).

RESULTS:

Compared to ABZ, better permeability was observed for different types and concentrations of ABCs using the Caco-2 monolayer cell model, with ABC-C8 showing the highest permeability. The transmembrane transport of ABCs was affected by ASBT inhibitors, indicating an ASBT-mediated active transport mechanism. Additionally, introducing cholic acid resulted in ABZ no longer being a substrate for P-gp, MRP2, and BCRP, effectively reversing ABZ efflux. In vivo unidirectional intestinal perfusion results in rats showed that ABCs altered the absorption site of ABZ from the jejunum to the ileum. The absorption efficiency of ABCs in each intestinal segment was higher than that of ABZ, and the transmembrane transport efficiency decreased with increasing concentrations of ASBT inhibitors. This further confirmed the presence of both passive diffusion and ASBT-mediated active transport mechanisms in the transport of ABCs. The solubility of ABCs in gastric juice and pharmacokinetics in rats showed that ABZ-C4 exhibited enhanced solubility. Moreover, ABCs significantly increased oral bioavailability compared to ABZ, with ABC-C4 showing an approximately 31-fold increase in bioavailability.

CONCLUSION:

The transmembrane transport mechanism of ABCs involves a combination of ASBT-mediated active transport and passive diffusion. Moreover, the incorporation of BAs successfully reverses the efflux of ABZ by efflux proteins. Among the synthesized conjugates, ABC-C4 demonstrated superior dissolution behavior both in vitro and in vivo.

2024-09-01·Liver International

Serum bile acid change correlates with improvement in pruritus in patients with primary biliary cholangitis receiving linerixibat

Article

作者: McLaughlin, Megan M. ; Carreño, Fernando ; Casillas, Linda ; Swift, Brandon ; Karatza, Eleni ; Fettiplace, James ; Kremer, Andreas E. ; Mukherjee, Sumanta ; Lennie, Janelle

Abstract:

Background & Aims:

Total serum bile acid (TSBA) levels are elevated in patients with primary biliary cholangitis (PBC) and may mediate cholestatic pruritus. Linerixibat, an ileal bile acid transporter inhibitor, improved pruritus in patients with PBC. We explored the relationship between linerixibat dose, TSBA concentration, and pruritus.

Methods:

Data from Phase 1/2 trials were used to develop a population kinetic‐pharmacodynamic model to characterize the linerixibat dose–TSBA relationship. Individual Bayesian parameter estimates for participants in the GLIMMER study were used to derive the area under the TSBA concentration curve over 24 h (AUC0–24). Time‐matched post hoc estimates of AUC0–24 were correlated with pruritus reported on a 0–10 numerical rating scale. Baseline TSBA concentration was correlated with change from baseline (ΔBL) in monthly itch score (MIS). ΔBL in model‐estimated TSBA AUC0–24 was correlated with time‐matched ΔBL in weekly itch score (WIS) or MIS.

Results:

Linerixibat dose dependently reduced TSBA AUC0–24, reaching steady state after 5 days. Baseline TSBA levels in GLIMMER did not correlate with ΔBL in MIS. ΔBL in TSBA AUC0–24 correlated with improved WIS over 12 weeks of treatment (r = 0.52, p < 0.0001). Of participants with a ≥30% decrease in TSBA AUC0–24, 60% were pruritus responders (≥2‐point improvement in WIS from baseline).

Conclusions:

Linerixibat treatment leads to rapid, dose‐dependent TSBA reductions. Baseline TSBA levels do not correlate with on‐treatment pruritus change, suggesting they do not predict linerixibat response. Change in TSBA AUC0–24 correlates significantly with, and can be predictive of, pruritus improvement in patients with PBC.

项与利奈昔巴特相关的新闻（医药）

2025-07-04

·医药观澜

GSK口服靶向新药「利奈昔巴特片」在中国拟纳入优先审评

今日（7月4日），中国国家药监局药品审评中心（CDE）官网公示，葛兰素史克（GSK）申报的利奈昔巴特片拟纳入优先审评，适用于治疗原发性胆汁性胆管炎（PBC）成人患者的胆汁淤积性瘙痒。公开资料显示，这是GSK在研的回肠胆汁酸转运蛋白（IBAT）抑制剂linerixibat。该产品的新药申请（NDA）已经于今年6月获美国FDA及欧洲药品管理局（EMA）受理，适应症为治疗原发性胆汁性胆管炎（PBC）成人患者的胆汁淤积性瘙痒。PBC作为一种胆汁淤积性肝病，会导致肝脏胆汁流动受阻。由此引发的循环胆汁酸过量被认为是胆汁淤积性瘙痒症（一种无法通过抓挠缓解的内源性瘙痒）的致病因素。该瘙痒可发生于PBC疾病或生化控制的任何阶段，严重程度各异，约90%的PBC患者会出现此症状。虽然PBC一线治疗可控制约70%患者的病情，但无法减轻瘙痒的严重程度或影响。胆汁淤积性瘙痒症是一种可能致残的严重病症，患者会出现睡眠障碍、疲劳、生活质量下降，甚至可能在未出现肝功能衰竭的情况下需进行肝移植。Linerixibat是一种IBAT口服抑制剂，具有治疗与PBC相关的胆汁淤积性瘙痒的潜力。通过抑制胆汁酸重吸收，linerixibat可减少循环中多种瘙痒介质。美国FDA和EMA已授予linerixibat用于治疗与PBC相关的胆汁淤积性瘙痒的孤儿药资格。Linerixibat此前已经在3期临床试验GLISTEN取得积极结果。GLISTEN是一项双盲、随机、安慰剂对照的3期试验，共纳入238名伴胆汁淤积性瘙痒的PBC患者，初始按1:1比例随机分配至活性药物组和安慰剂组。主要分析评估了linerixibat相较安慰剂的疗效和安全性。GLISTEN试验达到主要终点，结果显示，接受linerixibat治疗的患者（n=119）在24周内瘙痒显著改善，优于安慰剂组（n=119）。通过最严重瘙痒程度的数值评分量表（WI-NRS）进行评估，两组之间的最小二乘均值差为-0.72（95% CI：-1.15，-0.28，p=0.001）。该结果显示，linerixibat有望缓解PBC患者的一项主要症状——顽固性瘙痒。该研究还达成多个关键次要终点，包括第2周瘙痒评分改善及24周内瘙痒相关睡眠干扰评分的改善，具体表现如下：瘙痒改善起效迅速，第2周即优于安慰剂组，差异具有统计学意义（最小二乘均值差为-0.71，95% CI：-1.07，-0.34，p<0.001），且疗效在整个试验周期内持续维持。在24周的治疗周期中，与安慰剂相比，linerixibat显著改善了瘙痒引起的睡眠干扰，该症状对患者生活质量影响显著。到第24周，linerixibat组中有56%的患者瘙痒评分改善具有临床意义（WI-NRS降低≥3分），而安慰剂组为43%，治疗组之间的差异为13%（95% CI：0，27）。参考资料：[1]中国国家药监局药品审评中心（CDE）官网. Retrieved Jun 28, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c[2]Linerixibat accepted for review by the European Medicines Agency for cholestatic pruritus in patients with primary biliary cholangitis (PBC). From https://www.gsk.com/en-gb/media/press-releases/linerixibat-accepted-for-review-by-the-european-medicines-agency/[3] GLISTEN phase III trial results show linerixibat significantly improves cholestatic pruritus (relentless itch) in primary biliary cholangitis (PBC). Retrieved May 8, 2025, from https://www.gsk.com/en-gb/media/press-releases/glisten-phase-iii-trial-results-show-linerixibat-significantly-improves-cholestatic-pruritus/免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

优先审批孤儿药临床3期临床结果

2025-06-06

·PipelineReview

Linerixibat New Drug Application (NDA) accepted for review by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC)

LONDON, UK I June 02, 2025 I GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has accepted for review the NDA for linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), for the treatment of cholestatic pruritus in patients with PBC, a rare autoimmune liver disease. The Prescription Drug User Fee Act (PDUFA) goal date is 24 March 2026. Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: “The FDA’s acceptance of this file is an important milestone in the development of linerixibat. We believe that linerixibat has the potential to make a difference in the lives of patients living with relentless itch associated with PBC and its related sleep interference. These are debilitating symptoms which currently have very limited treatment options.” The application is based on positive data from the GLISTEN phase III trial, presented in May at the European Association for the Study of the Liver (EASL) Congress. GLISTEN met both primary and key secondary endpoints demonstrating a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference versus placebo. The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition. Linerixibat is currently not approved anywhere in the world. About cholestatic pruritus in PBC In PBC, a cholestatic liver disease, bile flow from the liver is disrupted. The resulting excess bile acids in circulation are thought to play a causal role in cholestatic pruritus, an internal itch that cannot be relieved by scratching. Pruritus can occur at any stage of PBC disease or biochemical control, and is experienced in varying degrees of severity by up to 90% of people living with PBC. 1 The first line treatment for PBC controls disease in approximately 70% of patients, but does not reduce the severity or impact of the pruritus. 2,3 Cholestatic pruritus is a serious condition that can be debilitating, with patients experiencing sleep disturbance, fatigue, impaired quality of life and even sometimes requiring liver transplantation in the absence of liver failure. 3,4 About linerixibat (GSK2330672) Linerixibat is an IBAT inhibitor, a targeted oral agent with potential to treat cholestatic pruritus (itch) associated with the rare autoimmune liver disease known as PBC. By inhibiting bile acid re-uptake, linerixibat reduces multiple mediators of pruritus in circulation. The US Food and Drug Administration and the European Medicines Agency have granted orphan drug designation for linerixibat in the treatment of cholestatic pruritus in patients with PBC. About the GLISTEN trial GLISTEN is a double-blind, randomised, placebo-controlled, phase III trial (NCT04950127; GSK study 212620) conducted in 238 PBC patients with cholestatic pruritus initially enrolled equally into active and placebo arms (n=119 each). The primary analysis evaluated the efficacy and safety of linerixibat compared with placebo. Participants with moderate to severe itch were enrolled. Participants initially received either linerixibat or placebo and had the potential to cross over in a part B of the trial. Primary and secondary outcome measures were assessed using a 0-10 numerical rating scale for worst itch and itch-related sleep interference. Stable use of guideline suggested anti-itch therapy was permitted. The trial was the first truly global PBC study completed in 19 countries including the Americas, Europe, China and Japan. About GSK research in hepatology GSK is currently investigating multiple potential treatments for patients with liver disease. In addition to PBC, we are also investigating potential treatments for chronic hepatitis B, alcohol-related liver disease (ALD), and metabolic dysfunction-associated steatohepatitis (MASH). About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References SOURCE: GlaxoSmithKline

临床3期临床结果申请上市孤儿药

2025-06-03

·GBIHealth

111亿美元！BioNTech合作BMS开发PD-L1×VEGF-A双抗

药械追踪No.1 / 赛诺菲行使选择权，4.8亿元获得Nurix STAT6项目独家许可2025年6月2日，Nurix Therapeutics, Inc.（简称“Nurix”，纳斯达克代码：NRIX）宣布，赛诺菲已行使选择权，获得Nurix在研STAT6项目的独家权益，这一候选药物（NX-3911）是一种口服的高选择性STAT6降解剂，可通过抑制STAT6信号治疗2型炎症相关疾病。赛诺菲此前于2019年12月与Nurix签署合作协议，运用Nurix专有的 DEL-AI 药物发现平台开发特定的靶向蛋白降解药物（TPD），协议涵盖共同开发和共同推广最多两种潜在产品的选择权。签署协议时，赛诺菲支付了5500万美元的首付款，其后又追加支付2200万美元以扩大合作范围。2025年4月，赛诺菲行使选择权获得Nurix一款未公开的TPD管线。此次赛诺菲再度行使选择权后，Nurix将获得1500万美元的许可延期费，使其基于该合作从赛诺菲获得的总款项达到1.27亿美元；此外Nurix还有资格获得与STAT6项目相关的4.65亿美元额外里程碑款，以及潜在的销售分成，并保留在美国共同开发和共同推广的选择权->点击文末阅读原文，解锁完整双语新闻No.2 / 百济神州双特异性HER2抑制剂百赫安获NMPA附条件批准2025年6月3日，百济神州（纳斯达克代码：ONC；香港联交所代码：06160；上交所代码：688235）宣布，双特异性HER2抑制剂百赫安（注射用泽尼达妥单抗）获得国家药品监督管理局（NMPA）附条件批准，用于治疗既往接受过全身治疗的HER2高表达（IHC3+）2的不可切除局部晚期或转移性胆道癌（BTC）患者。此次获批是基于关键性临床研究HERIZON-BTC-01（NCT04466891）的结果。该研究旨在评价泽尼达妥单抗用于治疗既往经治的、不可切除的HER2扩增性晚期或转移性BTC患者的有效性和安全性，结果显示泽尼达妥单抗疗效显著且安全性良好，经独立中心审查委员会（IRC）确认的ORR为51.6%，中位缓解持续时间（mDoR）为14.9个月，中位无疾病进展生存期（mPFS）7.2个月，中位总生存期（mOS）为18.1个月。泽尼达妥单抗是一种靶向HER2的人源化双特异性抗体，可与HER2上的两个非重叠的胞外位点近膜胞外结构域4（ECD4）和二聚化结构域2（ECD2）发生特异性反式结合，进而导致肿瘤细胞表面上的HER2受体减少，起到杀伤肿瘤的作用。2018年，百济神州与Zymeworks展开战略合作，在亚洲（不包括日本）、澳大利亚和新西兰共同开发和商业化泽尼达妥单抗。Jazz Pharmaceuticals负责该药物在美国、欧洲、日本和所有其他地区的开发和商业化。->点击文末阅读原文，解锁完整双语新闻No.3 / GSK IBAT抑制剂Linerixibat美国上市申请获FDA受理近日，葛兰素史克（GSK）宣布，linerixibat的新药上市申请（NDA）已获美国食品药品监督管理局（FDA）受理，用于治疗原发性胆汁性胆管炎（PBC）患者的胆汁淤积性瘙痒。Linerixibat是一种回肠胆汁酸转运体（IBAT）靶向抑制剂。此次NDA基于III期GLISTEN研究的积极数据，该研究已达到主要和关键次要终点，与安慰剂组相比，Linerixibat在缓解胆汁淤积性瘙痒及瘙痒相关睡眠受损方面具有快速、显著且持续的疗效。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 111亿美元！BioNTech合作BMS开发PD-L1×VEGF-A双抗2025年6月2日，BioNTech（Nasdaq:BNTX）宣布与百时美施贵宝（简称“BMS”，NYSE:BMY）达成一项全球战略合作协议，共同开发并商业化BNT327。BNT327是一款靶向PD-L1和VEGF-A的下一代双特异性抗体候选药物，拟用于治疗多种实体瘤。根据协议，双方将以50/50的比例共同承担BNT327的开发和商业化费用，并共担盈亏。BMS将向BioNTech支付15亿美元的首付款，并在2028年之前支付总计20亿美元的非或有年度付款。此外，BioNTech还可获得高达76亿美元的潜在开发、注册及商业化里程碑付款。BNT327目前正在进行多项临床试验，迄今已治疗超过1,000名患者，包括用于广泛期小细胞肺癌（ES-SCLC）和非小细胞肺癌（NSCLC）一线治疗的全球III期临床试验。其针对三阴性乳腺癌（TNBC）的全球III期临床试验计划于2025年底启动。初步研究数据显示，BNT327在多种肿瘤中具备临床获益潜力。->点击文末阅读原文，解锁完整双语新闻No.2 / 赛诺菲95亿美元收购Blueprint Medicines，扩充罕见免疫疾病管线2025年6月2日，赛诺菲（SNY.OQ）宣布将以每股129美元的现金收购总部位于美国的Blueprint Medicines，交易总额约91亿美元，若加上未来潜在的里程碑付款，整体交易估值达95亿美元。这项收购将使赛诺菲获得Blueprint在罕见免疫疾病领域的产品线，包括全球首个也是唯一获批治疗系统性肥大细胞增多症（SM）的药物Ayvakit/Ayvakyt，以及在研产品下一代KIT抑制剂elenestinib和高选择性口服野生型KIT抑制剂BLU-808。Blueprint专注于KIT驱动疾病及罕见免疫疾病，其产品管线有望增强赛诺菲在免疫学和肿瘤学的战略布局。Ayvakit/Ayvakyt在2024年实现了4.79亿美元的净收入，并在2025年第一季度录得近1.5亿美元的净收入，同比增长超过60%。此次收购预计将于2025年第三季度完成。赛诺菲预计此次收购将迅速提升公司毛利率，并在2026年后增加运营收入及每股收益。->点击文末阅读原文，解锁完整双语新闻No.3 / 再生元超20亿美元获翰森制药HS-20094全球权益2025年6月2日，翰森制药（3692.HK）宣布与再生元（NASDAQ: REGN）签署全球独家许可协议，授权再生元在除中国内地、香港和澳门外的全球范围内，开发、生产及商业化HS-20094。翰森制药将获得8000万美元首付款，并有资格根据产品开发、注册审批及商业化进展获得最高19.3亿美元的里程碑付款，以及未来产品销售的双位数百分比的特许权使用费。HS-20094是一款在研GLP-1/GIP双受体激动剂，已成功完成多项II期试验，目前正在中国进行III期临床研究，具备积极的疗效及安全性数据。->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

引进/卖出医药出海

100 项与利奈昔巴特相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11539	-	-	DB11729

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胆汁淤积性瘙痒	申请上市	美国	GSK Plc	2025-06-02
原发性胆汁性胆管炎	申请上市	美国	GSK Plc	2025-06-02
瘙痒	临床2期	澳大利亚	GSK Plc	2017-01-11
2型糖尿病	临床2期	美国	GSK Plc	2013-08-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04950127 (GLISTEN, Company_Website 1 \| Company_Website 2) 人工标引	临床3期	原发性胆汁性胆管炎	238	Linerixibat	願夢糧襯蓋鏇繭遞餘積(觸築鏇廠蓋淵構顧選鹹): Difference (LS Mean) = -0.72 (95% CI, -1.15 ~ -0.28), P-Value = 0.001 达到更多	积极	2024-11-19
				Placebo
NCT03992014 (CTgov)	临床1期	胆汁淤积	6	[14C] Linerixibat+Linerixibat (Linerixibat 90 mg Oral Tablets + [14C] Linerixibat 100 μg IV)	願襯鑰製鏇繭製廠鹹襯(夢觸構膚網簾製鹹膚壓) = 鏇願淵鏇壓製糧鹹衊糧壓繭餘簾襯獵醖鹽觸餘 (鏇衊範憲網淵糧廠製製, 25.8) 更多	-	2020-06-26
				[14C]-Linerixibat ([14C]-Linerixibat 90 Milligram Oral Solution)	鬱願齋簾鬱膚繭繭觸鏇(糧鹽鑰繭醖積齋衊壓壓) = 鏇製鹹遞襯淵積簾壓構廠遞憲積鑰範範範顧淵 (蓋糧夢鑰糧膚獵構夢艱, 95.3) 更多
NCT02202161 (CTgov)	临床2期	2型糖尿病	70	placebo+metformin+GSK2330672 (Placebo)	鹽鹹積鬱糧鹹簾鏇醖積(鏇壓壓壓餘鹽鹽夢艱衊) = 鑰壓醖顧選製鑰遞襯壓網壓願獵鏇膚淵鏇遞鹹 (築觸構網憲餘憲選觸製, 16.357) 更多	-	2017-11-06
				GSK2330672 (GSK2330672 10 mg BID)	鹽鹹積鬱糧鹹簾鏇醖積(鏇壓壓壓餘鹽鹽夢艱衊) = 淵積齋積選醖鹹艱範觸網壓願獵鏇膚淵鏇遞鹹 (築觸構網憲餘憲選觸製, 6.500) 更多
NCT01929863 (CTgov)	临床2期	2型糖尿病	16	Metformin+GSK2330672 (Treatment A-GSK2330672 + Metformin)	襯蓋衊觸構遞網衊鑰鏇 = 糧衊觸範鹽構蓋製選廠遞鏇餘窪鹹夢衊遞顧蓋 (網糧廠窪衊製膚糧鑰遞, 願窪窪遞壓繭夢網獵願 ~ 膚襯醖衊廠觸夢夢齋顧) 更多	-	2017-08-16
				Placebo+Metformin (Treatment B-Placebo + Metformin)	襯蓋衊觸構遞網衊鑰鏇 = 衊獵糧鬱襯鑰窪選淵膚遞鏇餘窪鹹夢衊遞顧蓋 (網糧廠窪衊製膚糧鑰遞, 遞廠糧構醖淵範簾選鬱 ~ 鏇壓壓夢願蓋鹽廠鏇餘) 更多
NCT01899703 (Pubmed \| Lancet) 人工标引	临床2期	瘙痒 \| 原发性胆汁性胆管炎	22	GSK2330672	壓網築築獵繭鏇憲夢艱(淵繭願膚醖醖顧鹹窪膚) = Diarrhoea was the most frequent adverse event during treatment with GSK2330672 (seven with GSK2330672 vs one with placebo) and headache was the most frequent adverse event during treatment with placebo (seven with placebo vs six with GSK2330672). 襯簾顧齋淵願壓廠壓廠 (艱廠構願鹹窪積簾蓋築 )	积极	2017-03-18
				Placebo