主要：评价linerixibat长期治疗患PBC胆汁淤积性瘙痒的受试者的安全性和耐受性次要：表征linerixibat长期治疗对患PBC胆汁淤积性瘙痒的受试者疾病负担和健康相关生活质量（QoL）的影响表征linerixibat长期治疗对患PBC胆汁淤积性瘙痒的受试者疾病负担和健康相关生活质量（QoL）的影响 *仅第1组受试者表征linerixibat长期治疗对患PBC胆汁淤积性瘙痒的受试者的影响探索性：评价linerixibat对肝脏纤维化和疾病进展的无创标志物的影响 **仅第2组受试者（如获得）

开始日期2023-02-10

申办/合作机构

葛兰素史克（中国）投资有限公司

NCT05435170 / Completed临床1期

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

100 项与 Linerixibat 相关的临床结果

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100 项与 Linerixibat 相关的转化医学

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100 项与 Linerixibat 相关的专利（医药）

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项与 Linerixibat 相关的文献（医药）

2024-01-01·JHEP reports : innovation in hepatology

Combined inhibition of bile salt synthesis and intestinal uptake reduces cholestatic liver damage and colonic bile salts in mice

Article

作者: van de Graaf, Stan F J ; van Dasselaar, Rychon D J ; Oude Elferink, Ronald P J ; Beuers, Ulrich ; Nijmeijer, Bart A ; Bolt, Isabelle ; Kunst, Roni F

Background & Aims:

Intestine-restricted inhibitors of the apical sodium-dependent bile acid transporter (ASBT, or ileal bile acid transporter) are approved as treatment for several inheritable forms of cholestasis but are also associated with abdominal complaints and diarrhoea. Furthermore, blocking ASBT as a single therapeutic approach may be less effective in moderate to severe cholestasis. We hypothesised that interventions that lower hepatic bile salt synthesis in addition to intestinal bile salt uptake inhibition provide added therapeutic benefit in the treatment of cholestatic disorders. Here, we test combination therapies of intestinal ASBT inhibition together with obeticholic acid (OCA), cilofexor, and the non-tumorigenic fibroblast growth factor 15 (Fgf15)/fibroblast growth factor 19 (FGF19) analogue aldafermin in a mouse model of cholestasis.

Methods:

Wild-type male C57Bl6J/OlaHsd mice were fed a 0.05% 3,5-diethoxycarbonyl-1,4-dihydrocollidine (DDC) diet and received daily oral gavage with 10 mg/kg OCA, 30 mg/kg cilofexor, 10 mg/kg ASBT inhibitor (Linerixibat; ASBTi), or a combination. Alternatively, wild-type male C57Bl6J/OlaHsd mice were injected with adeno-associated virus vector serotype 8 (AAV8) to express aldafermin, to repress bile salt synthesis, or to control AAV8. During a 3-week 0.05% DDC diet, mice received daily oral gavage with 10 mg/kg ASBTi or placebo control.

Results:

Combination therapy of OCA, cilofexor, or aldafermin with ASBTi effectively reduced faecal bile salt excretion. Compared with ASBTi monotherapy, aldafermin + ASBTi further lowered plasma bile salt levels. Cilofexor + ASBTi and aldafermin + ASBTi treatment reduced plasma alanine transaminase and aspartate transaminase levels and fibrotic liver immunohistochemistry stainings. The reduction in inflammation and fibrogenesis in mice treated with cilofexor + ASBTi or aldafermin + ASBTi was confirmed by gene expression analysis.

Conclusions:

Combining pharmacological intestinal bile salt uptake inhibition with repression of bile salt synthesis may form an effective treatment strategy to reduce liver injury while dampening the ASBTi-induced colonic bile salt load.

Impact and Implications:

Combined treatment of intestinal ASBT inhibition with repression of bile salt synthesis by farnesoid X receptor agonism (using either obeticholic acid or cilofexor) or by expression of aldafermin ameliorates liver damage in cholestatic mice. In addition, compared with ASBT inhibitor monotherapy, combination treatments lower colonic bile salt load.

2023-07-01·Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

New Treatment Paradigms in Primary Biliary Cholangitis

Review

作者: Levy, Cynthia ; Hirschfield, Gideon ; Manns, Michael

Primary biliary cholangitis (PBC) is an archetypal autoimmune disease. Chronic lymphocytic cholangitis is associated with interface hepatitis, ductopenia, cholestasis, and progressive biliary fibrosis. People living with PBC are frequently symptomatic, experiencing a quality-of-life burden dominated by fatigue, itch, abdominal pain, and sicca complex. Although the female predominance, specific serum autoantibodies, immune-mediated cellular injury, as well as genetic (HLA and non-HLA) risk factors, identify PBC as autoimmune, to date treatment has focused on cholestatic consequences. Biliary epithelial homeostasis is abnormal and contributes to disease. The impact of cholangiocyte senescence, apoptosis, and impaired bicarbonate secretion enhances chronic inflammation and bile acid retention. First-line therapy is a non-specific anti-cholestatic agent, ursodeoxycholic acid. For those with residual cholestasis biochemically, obeticholic acid is introduced, and this semisynthetic farnesoid X receptor agonist adds choleretic, anti-fibrotic, and anti-inflammatory activity. Future PBC licensed therapy will likely include peroxisome proliferator activated receptor (PPAR) pathway agonists, including specific PPAR-delta agonism (seladelpar), as well as elafibrinor and saroglitazar (both with broader PPAR agonism). These agents dovetail the clinical and trial experience for off-label bezafibrate and fenofibrate use. Symptom management is essential, and encouragingly, PPAR agonists reduce itch; IBAT inhibition (eg, linerixibat) also appears promising for pruritus. For those where liver fibrosis is the target, NOX inhibition is being evaluated. Earlier stage therapies in development include therapy to impact immunoregulation in patients, as well other approaches to treating pruritus (eg, antagonists of MrgprX4). Collectively the PBC therapeutic landscape is exciting. Therapy goals are increasingly proactive and individualized and aspire to rapidly achieve normal serum tests and quality of life with prevention of end-stage liver disease.

2023-07-01·Hepatology research : the official journal of the Japan Society of Hepatology

Japanese subgroup analysis of GLIMMER: A global Phase IIb study of linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis

Article

作者: McLaughlin, Megan M ; Das, Sugato ; Tanaka, Atsushi ; Notsumata, Kazuo ; Ito, Hiroshi ; Atsukawa, Masanori ; Tsuji, Keiji ; Suyama, Akari ; von Maltzahn, Robyn

Abstract:

Aim:

To compare patient characteristics and outcomes between the overall and Japanese populations of GLIMMER.

Methods:

GLIMMER was a multicenter, double‐blind, randomized, placebo‐controlled, Phase IIb study evaluating linerixibat for the treatment of pruritus in patients with primary biliary cholangitis.

Results:

In total, 147 patients were randomized in the GLIMMER overall population with 38 patients comprising the Japanese population. Demographics and baseline clinical characteristics were similar across treatment groups and between both populations. A reduction in mean worst daily itch score from baseline to week 16 (primary endpoint) was seen in all groups, with the largest reduction observed with linerixibat 40 mg twice daily (BID; −2.92 [95% confidence interval: −5.07, −0.76] and −2.86 [95% confidence interval: −3.76, −1.95] for Japanese and overall populations, respectively). The highest proportion of responders was generally in the 40 mg BID group in both populations regardless of the responder definition applied. Improvements in health‐related quality of life were generally consistent in both populations. In the Japanese and overall populations, on‐treatment drug‐related adverse events were reported in 25% and 19% of patients in the placebo group and 0%–86% and 31%–78% of patients in the linerixibat groups, respectively. Consistent with the mechanism of action, the most common events were gastrointestinal in nature. The effects of linerixibat on pharmacodynamic biomarkers favored BID dosing.

Conclusions:

Therapeutic responses and safety of linerixibat were consistent between the Japanese and overall populations of GLIMMER. Linerixibat may provide an effective treatment option for cholestatic pruritus in patients with primary biliary cholangitis.

Clinical Trial Registration:

NCT02966834.

项与 Linerixibat 相关的新闻（医药）

2024-06-24

·药智网

谁将成为全球第四款PBC新药？

原发性胆汁性胆管炎（PBC）是一种罕见的自身免疫性肝脏疾病，目前全球获批治疗PBC的药物非常有限，仅有3款药物。有限的治疗选择下，存在巨大的未满足的临床需求。 Coherent Market Insights报告显示，2017年全球PBC治疗市场规模为5.26亿美元，未来10年复合增长率将保持在36.3%，预计2026年将达到85.93亿美元。百亿美元市场待爆发，谁将成为全球第四款PBC药物？ 01 获批药物仅3款 PBC的进展与增加的肝相关死亡风险相关，目前其发病机制尚不明确，可能与遗传因素及其与环境因素相互作用所导致的免疫紊乱有关。目前，全球获批治疗PBC的药物非常有限。其中熊去氧胆酸（UDCA）是全球公认的PBC一线治疗药物，具有改善患者生化指标、缓解病理改变和延缓病程进展的作用，但约40%的患者对UDCA治疗应答不佳。 Ocaliva（奥贝胆酸）于2016年5月被FDA批准单药治疗无法耐受UDCA的成人PBC，或联合UDCA治疗UDCA疗效不佳的成人PBC。奥贝胆酸是一种法尼醇X受体（FXR）激动剂，其可以诱导肝细胞合成和分泌更多的胆汁酸，并抑制肝细胞合成甘油三酯，从而保护肝脏，减轻肝脏炎症、坏死和纤维化的进程。不过，Ocaliva治疗会导致患者的瘙痒症发生率增加，并引起低密度脂蛋白胆固醇水平升高。 Iqirvo（elafibranor）是近期获批的一款PBC新药，它是一种每日1次口服的过氧化物酶体增生激活受体(PPAR)激动剂，被FDA批准联合UDCA用于治疗对UDCA应答不足的成人PBC，或单药治疗对UDCA不耐受的PBC患者。 Ocaliva和Iqirvo这两款药物的适应症人群相同，均可降低PBC患者的血清碱性磷酸酶水平。值得注意的是，Ocaliva是全球首个获批的PBC二线疗法，业界非常看好该药，Evaluate Pharma曾预测其2020年销售额有望达到30亿美元，事实上，2020年其销售额为3.13亿美元。 02 Seladelpar即将撞线目前全球还有多款在研PBC新疗法，详见下表。这些在研PBC疗法作用靶点相对集中，主要包括PPAR、FXR。其中setanaxib作用靶点比较新颖，它是一种NOX4和NOX1抑制剂，具有抗炎和抗纤维化作用，曾被FDA授予治疗PBC的孤儿药资格认定。我国药企也积极布局PBC领域，不过在研药物最快处于2期临床，而且其中有些药物作用靶点未知，且药物类型不局限于小分子药物，如TB001是作用靶点未知的双靶点多肽药物。表1 全球部分在研PBC药物资料来源：公开资料整理 Seladelpar：正接受FDA优先审查 Seladelpar是一款口服强效选择性PPARδ激动剂，临床前和临床数据显示其具有参与调节胆汁酸合成、炎症、纤维化和脂质代谢、储存和运输基因的能力。目前，该药治疗PBC的新药申请正在美国接受优先审查，PDUFA日期为2024年8月14日。已公布的Seladelpar在对UDCA反应不足或不耐受的PBC患者中开展的全球3期临床试验RESPONSE的数据显示：seladelpar 10 mg组和5 mg组治疗组分别有78.2%和57.1%的患者达到复合终点，而安慰剂组仅有12.5%达到复合终点；5 mg和10 mg seladelpar治疗组中碱性磷酸酶（ALP）恢复正常的比例分别为5.4%(p=0.08)和27.3%(p<0.0001)，而接受安慰剂治疗的患者中ALP恢复正常的比例为0%；与安慰剂相比，中度至重度瘙痒(NRS≥4)患者中10 mg seladelpar对瘙痒的改善具有统计学意义(p<0.02)；与安慰剂组相比，seladelpar组丙氨酸转氨酶显著降低(5 mg:23.4%;10 mg:16.7%；安慰剂：4%)。此外，Seladelpar在PBC患者中开展的开放性扩展研究ASSURE也已取得积极结果。数据显示：10mg Seladelpar治疗组中70.3%的患者达到了具有临床意义的综合反应终点，37.2%的患者在12个月后达到了ALP正常化。此外，Seladelpar治疗还会显著降低PBC患者的谷氨酰转肽酶（GGT）、丙氨酸转氨酶（ALT）和总胆红素（TB）水平，分别降低36.4%、25.2%和9.2%。值得一提的是，Seladelpar由CymaBay开发，今年2月，吉利德通过斥资43亿美元收购CymaBay将Seladelpar纳入囊中。而吉利德之所以如此大手笔，正是看中了Seladelpar的潜力。CymaBay在与吉利德的沟通中给出了seladelpar明确的销售预期，2037年将实现23.94亿美元的最高峰值。 Linerixibat：缓解PBC瘙痒症状 Linerixibat是一种口服小分子回肠胆汁酸转运体（IBAT）抑制剂，其通过阻断小肠中胆汁酸的吸收，减少循环中瘙痒性胆汁酸，从而达到缓解瘙痒的目的。已公布的一项多中心、随机、平行组2期临床试验结果显示：Linearixibat可减轻胆汁淤积性瘙痒，且未发生严重不良事件。 CS0159和ASC42：PBC适应症已进入2期临床 CS0159是一种基于晶体结构辅助设计获得的新型强效非甾体类FXR小分子激动剂，被开发用于治疗PBC、PSC（原发性硬化性胆管炎）和NASH（非酒精性脂肪性肝炎）。系统的临床前研究表明，CS0159具有强效的FXR激动活性及肝靶向分布的特点，可明显改善NASH小鼠模型的病理状况，具有起效剂量低、药效显著且耐受性良好的特点。目前，该药治疗PBC的临床试验已进入2期阶段。 ASC42是歌礼制药自主研发的一款新型高效选择性非甾类FXR激动剂。美国开展的1期临床试验数据显示：在人体有效剂量15 mg、每日一次、为期14天的治疗过程中，未观察到瘙痒症状，而且FXR靶向激活的生物标志物成纤维细胞生长因子19（FGF19）在给药第14天时的增幅高达1780%。同时，LDL-C均值在治疗期间维持正常水平。2023年7月，ASC42治疗PBC的2期临床试验完成患者入组。 03 结语作为一种罕见肝病，PBC治疗虽取得一些可喜进展，但整体来看该市场并未饱和，获批药物数量也很有限。庆幸的是，目前国内外还有多款在研PBC新药，其中Seladelpar正在美国接受优先审查，预计很快就会和近来获批的elafibranor同台打擂。期待PBC治疗领域早日有新成员入局，为PBC患者提供更多选择。参考资料： 1.《原发性胆汁性胆管炎治疗药物临床研发进展》.凡默谷.2023-07-01 2.《APASL名家讲堂丨贾继东教授：原发性胆汁性胆管炎最新进展》.国际肝病.2023-02-26 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 德清君转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是昨天最受欢迎的文章哦

优先审批孤儿药临床2期

2024-06-12

·FierceBiotech

GSK signs AI pact with Ochre to pinpoint source of liver diseases

GSK’s interest in Ochre Bio lies in the company’s platform that allows livers to stay alive for a few days for the extraction of tissue samples. GSK and Ochre Bio will work together in a $37.5 million partnership to pinpoint the drivers of liver disease. The new partnership, announced Wednesday morning, will see GSK access Ochre’s computational biology, cellular and perfused human organ platforms to generate human liver data sets that can be used to better understand the biology of the liver. The goal, of course, is to eventually develop therapeutics to address liver diseases. The companies did not specify what indications they plan to target, however, GSK said the collaboration would complement its disease area focus in hepatology. The U.K. pharma has clinical assets in primary biliary cholangitis, metabolic dysfunction-associated steatohepatitis, cholestatic pruritus and hepatitis B, the latter of which dominates a large portion of its early-stage pipeline. GSK is advancing bepirovirsen in a phase 3 trial for chronic hepatitis B as a functional cure for the infection. The pharma expects annual sales of 2 billion pounds sterling ($2.57 billion) for the med. Also in phase 3 from the liver portfolio is linerixibat for cholestatic pruritus in primary biliary cholangitis, a condition that causes intense itch that is not satisfied by scratching. “In addition to our programs in MASH to hepatitis B, we are committed to addressing unmet need in liver disease by generating unique data in human-derived systems. Ochre Bio’s platform will provide GSK with foundational data sets to create AI models allowing us to better understand liver function and disease for the development of novel medicines,” said Kim Branson, senior vice president and global head of AI and machine learning at GSK, in a Wednesday statement. GSK’s interest in Ochre lies in the biotech’s platform that allows livers to stay alive for a few days for the extraction of tissue samples. GSK’s in-house AI and machine learning experts will analyze the data from the partnership and use it to build better models and, thus, more precise experiments for developing new liver disease therapeutics. The $37.5 million deal will include both co-exclusive and nonexclusive data licenses, but full details were not released.

临床3期临床2期

2024-05-02

·CPHI制药在线

从吉利德43亿美元交易，看PBC治疗进展

关注并星标CPHI制药在线近日，CymaBay Therapeutics（以下简称"CymaBay"）宣布了其核心管线seladelpar治疗原发性胆汁性胆管炎（PBC）的全球III期ENHANCE研究结果，引发市场关注。值得一提的是，今年2月12日，吉利德曾以每股32.5美元的价格现金收购CymaBay，总股权价值约为43亿美元。此次收购将进一步扩充吉利德肝脏领域的产品线组合。同时seladelpar也成为吉利德重返肝病领域的一把"利剑"。那么，seladelpar有哪些独特优势？ PPARδ激动剂：Seladelpar Seladelpar是一款强效、选择性过氧化物酶体增殖物激活受体（PPAR）δ激动剂，具有调节胆汁酸合成、炎症、纤维化和脂质代谢、储存和运输基因的能力。 PPARδ属于PPARs的一种。PPARs是一类核转录因子，能够调控多种参与细胞内外脂类代谢的目的基因表达，以及脂肪细胞的分化。PPAR基因有PPARα、β、γ三种亚型，β亚型也叫PPARδ，其几乎在所有组织均有低水平表达。在针对PBC患者的全球III期RESPONSE研究中，评估了使用seladelpar与安慰剂相比，在对熊去氧胆酸（UDCA）反应不足或不耐受的原发性PBC患者中的有效性和安全性。结果显示：在seladelpar 10 mg组和5 mg组，分别有78.2%和57.1%的患者达到了复合终点，而安慰剂组仅有12.5%达到了复合终点。接受5 mg和10 mg seladelpar治疗的患者中，碱性磷酸酶（ALP）恢复正常的比例分别为5.4% (p= 0.08)和27.3% (p < 0.0001)；而接受安慰剂治疗的患者中ALP恢复正常的比例为0%。目前，ALP是受到FDA认可的治疗PBC的替代终点。此次RESPONSE研究的公布，揭示了seladelpar在PBC治疗领域的潜力。 PBC领域新药研发进展 PBC是一种罕见的慢性进行性自免肝病，会导致肝硬化和肝功能衰竭，免疫应答失常被认为是PBC发病的重要原因。目前获FDA批准用于PBC治疗的药物仅2款：熊去氧胆酸（UDCA）和奥贝胆酸（Ocaliva），其中接受熊去氧胆酸治疗的患者中，约有40%的患者不产生治疗应答；奥贝胆酸则因肝损伤风险被FDA给予黑框警告。因此，寻找安全、有效的治疗药物无比紧迫。目前，PBC治疗新药主要分为PPAR激动剂、FXR激动剂、IBAT抑制剂等。 PPAR激动剂 PPAR激动剂代表药物除了CymaBay的Seladelpar外，还有印度Zydus Cadila公司的Saroglitazar，这是一款PPARα/γ双重激动剂，同时具有调节PPARα和PPARγ活性的功能。Saroglitazar最早于2013年9月在印度获批，用于治疗非他汀类药物控制的2型糖尿病患者的糖尿病血脂异常和高甘油三酯血症。在治疗对UDCA应答不佳的PBC患者的临床试验中，在Saroglitazar 4mg组和 2mg组与对照组相比，第4周时，Saroglitazar 4mg组和2mg组的ALP水平均迅速降低，这在整个治疗过程中一直持续。第16周时，Saroglitazar 4mg、2mg和对照组中，GGT（谷氨酰转移酶）水平分别降低79.7U/L、124.5U/L和30.9U/L。与基线相比，ALP水平降低≥15%患者百分比在Saroglitazar 4mg（84.6%）和2mg组（92.9%），均显著高于对照组（仅20%）。本研究表明Saroglitazar即使在对UDCA无反应的患者中也可能起作用，为难治性PBC患者提供了新的、有潜力的治疗方法。 FXR激动剂法尼醇X受体（FXR）是一种参与胆汁酸稳态调节的核激素受，可抑制胆酸合成限速酶基因CYP7A1的表达，抑制胆汁酸（BA）合成；其次，可以抑制肝细胞NTCP/OATP表达，抑制BA重吸收；而且可以促进肝细胞BSEP表达，从而促进BA排泄。因此，FXR被视为治疗PBC的理想靶点。奥贝胆酸就是一款FXR激动剂，除此之外，代表药物还有Tropifexor，这是一款由诺华研发的FXR激动剂，在PBC患者治疗中，GGT和ALP均有改善，但ALP下降幅度低，存在瘙痒副作用。 IBAT抑制剂回肠胆汁酸转运蛋白（IBAT）抑制剂主要用来开发治疗PBC患者的胆汁淤积性瘙痒症，目前已进展至全球III期临床。在PBC患者中，用于肝脏的胆汁流出受到干扰，产生的过量胆汁酸被认为会引起胆汁淤积性瘙痒，且不能通过抓挠来缓解，可使人衰弱、疲劳等，甚至需要进行肝移植。 GSK研发的linerixibat是一种IBAT小分子抑制剂，通过阻断小肠中胆汁酸的吸收，减少循环中瘙痒性胆汁酸，从而达到缓解瘙痒的目的。在一项针对PBC胆汁淤积性瘙痒患者进行的IIb期研究中，结果显示，linerixibat可显著改善患者的瘙痒程度。 PBC作为一种慢性胆汁淤积性肝病，在我国发病率及患病率均呈逐渐上升的趋势。尽管UDCA 可以改善患者的长期预后和生存率，但仍有约40%的患者应答不佳，由于现有可用药物的局限性，研究者开始寻求新的治疗药物，其中以FXR激动剂和PPAR激动剂潜力最大。主要参考资料： 1.Raj Vuppalanchi, Stephen H. Caldwell，Nikolaos Pyrsopoulos，et al.Proof-of-concept study to evaluate the safety and efficacy of saroglitazar in patients with primary biliary cholangitis[J].J Hepatol.2022；76:75-85. 2.https://us.gsk.com/en-us/media/press-releases/gsk-presents-phase-2b-data-on-linerixibat-for-the-treatment-of-cholestatic-pruritus-in-primary-biliary-cholangitis-pbc/. 【智药研习社近期线下课程预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

临床3期临床结果并购

100 项与 Linerixibat 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11539	-	-	DB11729

研发状态

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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	临床3期	美国	GSK Plc	2020-07-14
胆汁淤积性瘙痒	临床3期	中国	GSK Plc	2020-07-14
胆汁淤积性瘙痒	临床3期	日本	GSK Plc	2020-07-14
胆汁淤积性瘙痒	临床3期	阿根廷	GSK Plc	2020-07-14
胆汁淤积性瘙痒	临床3期	比利时	GSK Plc	2020-07-14
胆汁淤积性瘙痒	临床3期	巴西	GSK Plc	2020-07-14
胆汁淤积性瘙痒	临床3期	保加利亚	GSK Plc	2020-07-14
胆汁淤积性瘙痒	临床3期	加拿大	GSK Plc	2020-07-14
胆汁淤积性瘙痒	临床3期	捷克	GSK Plc	2020-07-14
胆汁淤积性瘙痒	临床3期	法国	GSK Plc	2020-07-14

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临床结果

适应症

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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


NCT03992014 (CTgov)	临床1期	胆汁淤积	6	Linerixibat (Linerixibat 90 mg Oral Tablets + [14C] Linerixibat 100 μg IV)	齋醖觸鬱鑰構顧鏇夢襯(夢襯鹹醖鬱窪簾遞窪鏇) = 鹽淵壓獵糧廠窪構鹹淵鏇鏇願窪艱構顧願餘顧 (窪糧遞築鹽淵鹹繭願壓, 糧醖餘衊鏇觸構鹹製鹹 ~ 鹽選糧壓齋鏇鬱獵齋遞) 更多	-	2020-06-26
				[14C]-Linerixibat ([14C]-Linerixibat 90 Milligram Oral Solution)	壓襯淵糧壓獵鬱憲鏇壓(顧襯構鏇製艱膚選網憲) = 襯製積齋夢鏇艱構鏇製淵窪觸範窪鹹繭鑰願鹹 (淵夢觸襯積範淵選餘遞, 淵醖憲願網鏇積憲願艱 ~ 憲願窪簾範齋衊鬱鹹網) 更多
NCT02202161 (CTgov)	临床2期	2型糖尿病	70	placebo+GSK2330672+metformin (Placebo)	製襯醖襯餘齋選簾膚鹽(襯鏇淵築築蓋觸製齋觸) = 願淵衊鹹衊簾齋積鑰觸網構築遞鹽築構窪選觸 (網窪憲範襯簾夢網網選, 廠顧顧繭鑰鑰鹽鬱窪簾 ~ 簾膚網簾觸淵鬱簾構艱) 更多	-	2017-11-06
				GSK2330672 (GSK2330672 10 mg BID)	製襯醖襯餘齋選簾膚鹽(襯鏇淵築築蓋觸製齋觸) = 醖鑰觸積築鏇網構選襯網構築遞鹽築構窪選觸 (網窪憲範襯簾夢網網選, 繭觸廠壓獵憲顧衊蓋選 ~ 窪壓艱憲壓簾膚廠顧獵) 更多
NCT01929863 (CTgov)	临床2期	2型糖尿病	16	GSK2330672+Metformin (Treatment A-GSK2330672 + Metformin)	廠簾醖齋製獵築夢簾選(鏇夢襯遞憲齋鬱衊簾衊) = 願顧鏇膚廠遞蓋簾淵鑰醖願鬱艱廠衊簾齋鑰廠 (製淵艱廠獵鬱艱壓繭憲, 顧遞鑰簾醖衊齋顧顧齋 ~ 鬱願網顧艱鬱範獵觸選) 更多	-	2017-08-16
				Placebo+Metformin (Treatment B-Placebo + Metformin)	廠簾醖齋製獵築夢簾選(鏇夢襯遞憲齋鬱衊簾衊) = 壓鹽餘鏇繭膚鬱醖齋鏇醖願鬱艱廠衊簾齋鑰廠 (製淵艱廠獵鬱艱壓繭憲, 願選艱築遞醖淵膚鏇夢 ~ 繭選齋遞鏇壓餘選網獵) 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	壓鏇繭夢廠醖範艱簾選(簾鏇壓窪鏇膚廠膚顧顧) = 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). 願簾鹹鬱蓋壓顧醖醖鬱 (壓顧壓餘繭壓遞範艱憲 )	积极	2017-03-18
				Placebo