Elafibranor Pregnancy Surveillance Program: A Post Marketing, Long Term, Multi-Center, Noninterventional, and Descriptive Study to Characterize Pregnancy and Maternal Complications and to Describe Effects on the Developing Fetus, Neonate and Infant Among Individuals Exposed to Elafibranor During Pregnancy

The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
Information will be collected from participants, their healthcare providers, published studies, and safety databases. Reports of pregnancy linked to elafibranor from clinical trials, spontaneous reports, or literature will also be included, with steps taken to avoid duplicates.
The study begins once the first participant is enrolled and ends after the last mother and child data are collected. It is planned to run for about 10 years, with infant follow-up lasting up to 2 years, for a maximum total duration of 12 years and 9 months.
The program is strictly observational. All medical care, visit schedules, and treatment decisions remain with healthcare providers. Only routine medical record data will be collected, and no extra tests or procedures are required.
Participation is voluntary, and written informed consent will be obtained before enrollment.

开始日期2026-07-29

申办/合作机构

Ipsen SA

NCT07387549

/ Recruiting临床3期

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis

The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC). PSC is a rare disease that causes inflammation and scarring of the bile ducts in the liver. Over time, this can lead to liver damage and serious health problems, including the need for a liver transplant and death.
In this study, about 350 participants with large duct PSC will take part. Participants will be randomized to receive either elafibranor 120 mg once daily or a placebo (a tablet with no active medicine). The study includes a screening period, an treatment period, and a post-treatment safety follow-up.
During the study, participants will undergo routine clinical assessments, laboratory testing, imaging evaluations, and complete patient-reassessments to evaluate liver disease progression, symptoms, quality of life and safety.
Following the end of treatment, participants will complete a safety follow-up period at approximately four weeks. Participants may withdraw from the study at any time. Each participant may be in the study for several years, as the treatment period will continue until the study reaches enough health events among participants, which is expected to take about 5 years.

开始日期2026-05-14

申办/合作机构

Ipsen SA

DRKS00039209

/ RecruitingN/A

Safety and efficacy of elafibranor therapy in patients with primary biliary cholangitis and liver cirrhosis. - Elafibranor in patients with primary biliary cholangitis and liver cirrhosis.

开始日期2026-03-16

申办/合作机构-

100 项与依非兰诺相关的临床结果

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100 项与依非兰诺相关的转化医学

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100 项与依非兰诺相关的专利（医药）

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161

项与依非兰诺相关的文献（医药）

2026-10-02·MEDICINE

Safety profile of elafibranor versus placebo in primary biliary cholangitis

Review

作者: Khan, Naveed Ahmed ; Adhikari, Pukar ; Khan, Muhammad Azam ; Talha, Muhammad ; Anwar, Umar ; Shahbaz, Hunain ; Khan, Muhammad Abdullah ; Tahir, Muhammad Aliyan

Background::

While elafibranor’s safety has been addressed within a 3 outcome network meta-analysis of second-line primary biliary cholangitis (PBC) agents and within a mixed design review using serious adverse events (AEs) as its sole safety endpoint, no review has yet applied trial sequential analysis (TSA) or Grading of Recommendations Assessment, Development and Evaluation (GRADE) certainty assessment to a dedicated, 10-outcome, placebo-controlled elafibranor evidence base. PBC is a chronic autoimmune liver disease affecting the small bile ducts, with approximately 30% to 40% of patients failing to respond adequately to first-line ursodeoxycholic acid (UDCA) therapy. Elafibranor, a dual peroxisome proliferator-activated receptor α/δ agonist, received Food and Drug Administration and European Medicines Agency approval in 2024 as a second-line option, yet no pooled randomized evidence for its safety profile had been synthesized.

Methods::

We conducted a systematic review and meta-analysis of RCTs comparing elafibranor with placebo in UDCA-inadequate-responder PBC patients, searching PubMed, Scopus, and Embase through June 2026. Three RCTs (Schattenberg 2021, Kowdley 2024/ELATIVE, Levy 2026/ELMWOOD) enrolling 274 patients (elafibranor n = 183; placebo n = 91) were included, all with low risk of bias. Ten safety outcomes were pooled via a random-effects model, with GRADE and TSA.

Results::

Elafibranor showed no significant difference from placebo across any prespecified safety outcome. The primary outcome, any AE, showed RR 1.06 (95% CI: 0.97–1.16; I2 = 0%). Trends favored elafibranor for pruritus (RR 0.77) and fatigue (RR 0.71), with modest nonsignificant increases for nausea and treatment-related AEs. GRADE certainty was moderate across outcomes, downgraded solely for imprecision. TSA confirmed futility for any AE but found the remaining 9 outcomes substantially underpowered, with only 2.2% to 9.7% of required information accrued.

Conclusion::

Elafibranor shows a broadly reassuring safety profile, with encouraging trends toward improved pruritus and fatigue. However, evidence remains insufficient for definitive conclusions on rare or long-term safety signals, underscoring the need for larger, adequately powered trials. Jointly applying GRADE and TSA to this dedicated, placebo-controlled elafibranor evidence base clarifies which safety signals are genuinely null versus underpowered, a distinction broader second-line PBC comparisons have not resolved.

2026-09-01·DIGESTIVE AND LIVER DISEASE

AISF practice guidance on the treatment of primary biliary cholangitis: A 2026 update

Review

作者: Fianchi, Francesca ; Carbone, Marco ; Aghemo, Alessio ; Labanca, Sara ; Ronca, Vincenzo ; Viganò, Mauro ; D’ambrosio, Roberta ; Cristoferi, Laura ; Marzioni, Marco ; Invernizzi, Pietro ; Cazzagon, Nora ; Tovoli, Francesco ; Marrone, Giuseppe ; Calvaruso, Vincenza ; Giannini, Edoardo Giovanni ; Valsecchi, Alessandro ; Gitto, Stefano ; Pennisi, Grazia ; Terracciani, Francesca ; Gentilucci, Umberto Vespasiani ; Lleo, Ana ; Ponziani, Francesca Romana ; Germani, Giacomo ; D’Amato, Daphne ; Rigamonti, Cristina

Primary biliary cholangitis (PBC) is a chronic autoimmune cholestatic liver disease that, if untreated or inadequately treated, may progress to advanced fibrosis, cirrhosis, and liver-related complications. Although ursodeoxycholic acid (UDCA) remains the cornerstone of first-line therapy and improves transplant-free survival, an important proportion of patients show an inadequate biochemical response, and many continue to experience substantial symptoms, particularly pruritus and fatigue, with a major impact on quality of life. In recent years, the therapeutic landscape of PBC has evolved following the withdrawal of obeticholic acid and the availability of selective PPAR agonists, including elafibranor and seladelpar. At the same time, disease management has shifted beyond a dichotomous definition of biochemical response toward a risk-based and holistic approach integrating biochemical response, fibrosis stage, liver stiffness, and patient-reported outcomes. Therapeutic targets should be individualized according to age, disease stage, symptom burden, and risk of progression, distinguishing between "adequate" and "complete" biochemical response and supporting earlier treatment escalation in high-risk and symptomatic patients. This updated AISF guidance provides an evidence-based framework for PBC management in 2026 and beyond, reviewing therapeutic goals, response criteria, second-line therapies, and management in specific settings, including cirrhosis, pregnancy, variant syndromes, and metabolic comorbidities, emphasizing a patient-centred approach and highlighting unmet needs and future directions.

2026-09-01·WIENER KLINISCHE WOCHENSCHRIFT

Austrian Society of Gastroenterology and Hepatology (ÖGGH) consensus on primary biliary cholangitis

Article

作者: Burghart, Lukas ; Stradner, Martin ; Peck-Radosavljevic, Markus ; Fickert, Peter ; Schaefer, Benedikt ; Mandorfer, Mattias ; Trauner, Michael ; Maieron, Andreas ; Aigner, Elmar ; Hofer, Harald ; Graziadei, Ivo ; Halilbasic, Emina ; Zoller, Heinz ; Traussnigg, Stefan ; Hofer, Benedikt Silvester ; Tatscher, Elisabeth ; Sieghart, Wolfgang ; Hametner-Schreil, Stephanie ; Wagner, Martin

Summary:

This consensus document of the Austrian Society of Gastroenterology and Hepatology (ÖGGH) is intended to provide practical guidance for the management of individuals with primary biliary cholangitis (PBC).PBC is a chronic inflammatory, autoimmune-mediated disease of the intrahepatic bile ducts that can lead to fibrosis and ultimately cirrhosis. Middle-aged women are significantly more frequently affected than men. The pathogenesis is currently not fully understood. Based on the presence of disease-specific autoantibodies, it is classified as an autoimmune liver disease, although a combination of genetic predisposition and environmental factors contribute to disease development and progression.The diagnosis of PBC is based on a cholestatic enzyme pattern together with the presence of anti-mitochondrial antibodies (AMA) or PBC-specific anti-nuclear antibodies (sp100, gp210). A liver biopsy is rarely required to establish the diagnosis; exceptions are the suspicion of a PBC autoimmune hepatitis (AIH) variant syndrome or the absence of the abovementioned antibodies. The therapeutic goal is to reduce cholestatic injury thereby preventing disease progression and to reduce symptoms. Approximately 60–70% of patients achieve clinical and biochemical remission with first-line treatment, i.e., ursodeoxycholic acid (UDCA). Recently, the therapeutic paradigm has shifted from achieving certain predefined response criteria to a normalization of alkaline phosphatase (ALP) together with a low-normal bilirubin level, as the latter was linked to improved outcomes in some subgroups. For patients who do not sufficiently respond to UDCA, the newly approved peroxisome proliferator-activated receptor (PPAR) agonists elafibranor and seladelpar, as well as bezafibrate ( off-label use), should be used as a combination treatment with UDCA. In patients with decompensated cirrhosis, liver transplantation has been associated with good long-term outcomes, albeit disease recurrence occurs in up to 50% by 15 years.

410

项与依非兰诺相关的新闻（医药）

2026-10-27

·手机新浪网

益普生2026前三季度销售额高增上调全年指引，管线并购稳步推进

【新华企业资讯10月27日】全球特药领域生物制药公司益普生于2026年10月23日公布了2026年年初至今及第三季度的销售业绩。益普生首席执行官David Loew表示：“我们在2026年前三季度的出色业绩得益于核心产品组合的强劲表现和索马杜林的持续增长。这一增长势头，加上严格高效的执行，为我们进一步上调全年销售额和利润率指引提供了有力支持。展望未来，我们对研发管线所带来的机遇倍感振奋。随着Dysport拓展至发作性和慢性偏头痛领域，以及Iqirvo有望新增原发性胆汁性胆管炎适应症，我们将有机会满足更多未被满足的医疗需求，惠及更广泛的患者。我们也非常期待navtemadlin治疗骨髓纤维化的Ⅲ期临床试验结果能在明年公布。此外，potravitug在治疗移植后肾病领域的发展前景同样令人振奋。这些极具差异化的后期研发管线充分彰显了我们在持续推进极具潜力的新药研发方面的决心，致力于为患者健康带来切实的改变。”基于年初至今的强劲业绩表现，益普生进一步上调了2026年财务指引：• 总销售额增长约23.0%（按固定汇率计算，CER）。基于10月的平均汇率水平，预计汇率将对总销售额产生约0.5%的不利影响• 核心运营利润率约占总销售额的39.0%全年销售额和核心运营利润率指引基于以下假设：核心产品组合将继续实现强劲的两位数增长；尽管第四季度将有兰瑞肽仿制药上市，索马杜林的销售额仍将保持增长。第三季度，益普生完成了对Memo Therapeutics和Kartos Therapeutics的收购，将处于后期研发阶段的抗BK多瘤病毒单克隆抗体potravitug和用于治疗骨髓纤维化、处于Ⅲ期开发阶段的MDM2抑制剂navtemadlin纳入公司管线。这些并购进一步增强了益普生在罕见病和肿瘤领域的研发管线实力，并通过布局具有差异化优势的后期研发资产，构建长期增长动力的发展战略。益普生加强了后期研发管线，推进关键项目并拓展新疾病领域：• 在肿瘤领域，通过收购navtemadlin以及IPN60340的开发，进一步增强益普生在血液肿瘤领域（包括骨髓纤维化和急性髓系白血病）的研发布局。• 在罕见病领域，继续推进elafibranor治疗原发性硬化性胆管炎的Ⅲ期临床开发，Iqirvo治疗原发性胆汁性胆管炎适应症的注册申报正在进行中，近期收购的potravitug新增了移植后肾病的Ⅱ/Ⅲ期临床项目。• 在神经科学领域，Dysport正在进行注册申报，有望成为首个在慢性和发作性偏头痛Ⅲ期研究中均取得积极顶线结果的肉毒毒素；同时，同类首创重组神经抑制剂corabotase（RNI™）正在推进治疗性和医美适应症的Ⅱ期和Ⅲ期临床开发。说明：所有财务数据均以百万欧元（€m）为单位。除非另有说明，本报告的业绩涵盖2026年9月30日之前的9个月（YTD2026）和2026年9月30日之前的3个月（2026年第三季度），而数据对比的对象为2025年9月30日之前的9个月（YTD2025）和2025年9月30日之前的3个月（2025年第三季度）。除非另有说明，否则评论基于2026年年初至今的业绩。

2026-10-26

·百度百家

益普生2026年前三季度销售额强劲走高，上调全年销售与利润率指引

全球特药生物制药企业益普生(Euronext：IPN;ADR：IPSEY)公布2026年年初至今及第三季度销售业绩，整体业务实现强劲增长，公司同步上调2026全年财务指引。　　按固定汇率CER口径统计，2026年初至今公司总销售额增幅达到24.6%;以报告汇率计算同比增长23.0%，不含索马杜林的核心产品组合销售额增长24.2%。分板块来看，肿瘤业务年初至今销售额21.969亿欧元，同比实际增长14.9%、固定汇率口径增长16.3%;罕见病板块4.982亿欧元，实际增幅95.0%、固定汇率增幅100.1%;神经科学板块6.691亿欧元，实际增长17.9%、固定汇率增长18.8%。前三季度合计总销售额33.642亿欧元，对比去年同期27.348亿欧元实现显著提升。　　单看第三季度，益普生总销售额11.739亿欧元，去年同期为9.150亿欧元，报告汇率下增长28.3%，固定汇率下增长26.7%。其中肿瘤板块单季7.454亿欧元，罕见病1.935亿欧元，神经科学2.351亿欧元，三大核心治疗领域均保持双位数增长。　　依托前三季度亮眼表现，益普生更新全年预期：固定汇率口径总销售额增速目标上调至约23.0%，此前目标为固定汇率下增速超20.0%;核心营业利润率上调至总销售额的约39.0%，原指引为超过37.0%。公司说明，基于10月平均汇率，汇率因素预计对全年总销售额带来约0.5%的负面影响。本次指引建立在两项前提之上：核心产品组合持续保持强劲双位数增长;即便第四季度兰瑞肽仿制药上市，索马杜林依旧维持销售增长。　　益普生首席执行官DavidLoew表示，前三季度优异业绩来自核心产品组合的稳健表现以及索马杜林的持续放量。良好增长叠加高效执行，支撑公司上调全年销售和利润率目标。同时，公司对后期研发管线蕴藏的机会抱有信心：Dysport将拓展至发作性、慢性偏头痛适应症;Iqirvo有望新增原发性胆汁性胆管炎适应症，覆盖更多未被满足的临床需求;navtemadlin针对骨髓纤维化的Ⅲ期临床结果预计明年公布;potravitug在移植后肾病方向潜力突出。差异化后期管线，体现益普生持续投入新药研发、为患者创造临床价值的决心。　　第三季度益普生完成两项收购，拿下MemoTherapeutics与KartosTherapeutics，将处于后期研发阶段的抗BK多瘤病毒单克隆抗体potravitug和用于治疗骨髓纤维化、处于Ⅲ期开发阶段的MDM2抑制剂navtemadlin纳入公司管线，补强罕见病、肿瘤赛道布局，依靠差异化后期资产搭建长期增长引擎。　　研发管线层面多项项目稳步推进：　　• 在肿瘤领域，通过收购navtemadlin以及IPN60340的开发，进一步增强益普生在血液肿瘤领域(包括骨髓纤维化和急性髓系白血病)的研发布局　　• 在罕见病领域，继续推进elafibranor[4]治疗原发性硬化性胆管炎的Ⅲ期临床开发，Iqirvo治疗原发性胆汁性胆管炎适应症的注册申报正在进行中，近期收购的potravitug新增了移植后肾病的Ⅱ/Ⅲ期临床项目　　• 在神经科学领域，Dysport 正在进行注册申报，有望成为首个在慢性和发作性偏头痛Ⅲ期研究中均取得积极顶线结果的肉毒毒素;同时，同类首创重组神经抑制剂corabotase(RNI™)正在推进治疗性和医美适应症的Ⅱ期和Ⅲ期临床开发　　免责声明：此文内容为本网站转载企业资讯，仅代表作者个人观点，与本网无关。所涉内容不构成投资、消费建议，仅供读者参考，并请自行核实相关内容。原文转自：信阳新闻网

2026-10-26

·华益药业

药闻动态 | 一周药闻 10.19-10.25

法规公告 NMPA：国家药监局关于发布仿制药参比制剂目录（第一百一十批）的通告（2026年第37号）经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第一百一十批）。 https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20261019165946162.html NMPA：国家药监局综合司公开征求《药品市场独占期实施办法（征求意见稿）》意见为进一步鼓励罕见病治疗用药品和儿童用药品研发，做好新修订《中华人民共和国药品管理法实施条例》的配套实施工作，国家药监局组织起草了《药品市场独占期实施办法》（见附件1），现向社会公开征求意见。 https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20261019175753196.html CDE：关于公开征求《药品市场独占期工作程序（征求意见稿）》意见的通知为配合国家药监局《药品市场独占期实施办法》贯彻落实，规范药品市场独占期制度具体实施工作，我中心起草了《药品市场独占期工作程序》，经中心内部讨论研究，并组织行业专家、企业代表研讨完善，形成了征求意见稿，现公开征求意见。 https://www.cde.org.cn/main/news/viewInfoCommon/51b398b238d1d30903504260ab1fb658 CDE：关于公开征求《M13A低风险制剂清单（第二批）》意见的通知为落实ICH《M13A：口服固体速释制剂的生物等效性》中制剂风险评估原则，指导企业提高研发效率，同时参考国际其他监管机构的技术要求，我中心拟定了M13A低风险制剂清单（第二批，见附件），现向社会公开征求意见。 https://www.cde.org.cn/main/news/viewInfoCommon/ab4430fa432def835650fd80eb6af807 企业动态 1、北京泰德制药股份有限公司申报的贝前列素钠缓释片获批上市，打破了原研在该剂型的垄断局面，临床主要用于治疗肺动脉高压，改善慢性动脉闭塞性疾病引起的溃疡、间歇性跛行、疼痛和冷感等症状。 2、正大天晴药业集团的乌美溴铵维兰特罗吸入粉雾剂获批上市，为国内首仿。临床用于慢性阻塞性肺病患者的长期维持治疗，现为国家医保谈判目录品种。2025年，乌美溴铵维兰特罗的全球销售额约7亿美元，在中国市场的销售额为1.2亿元。 3、千金药业的乌帕替尼缓释片获批上市，该产品是艾伯维开发的一种选择性JAK抑制剂，2022年获批进入中国市场，随后进入了国家医保谈判目录。2025年在中国市场的销售额已涨至9.9亿元，2026年有望突破10亿元关口。 4、北京福元医药股份有限公司申报的罗替高汀贴片获批上市，用于早期特发性帕金森病症状及体征的单药治疗，或与左旋多巴联合用于病程中的各个阶段。与其他口服药物相比，透皮贴剂可减少胃肠道不良反应、避免血药浓度波动并减少运动症状起伏，提高患者用药安全性与依从性。 5、石药集团/和铂医药申报的进口1类新药巴托利单抗注射液获批上市，这是一款靶向FcRn的全人源单克隆抗体，于2021年1月被CDE纳入突破性治疗药物程序，为全身型重症肌无力(gMG)患者提供新的治疗选择。 6、葛兰素史克（GSK）官方宣布，反义寡核苷酸（ASO）药物贝普若韦生（bepirovirsen）获美国FDA批准，用于联合核苷（酸）类似物逆转录酶抑制剂（NrtI）治疗慢性乙型肝炎（CHB）。这是全球首个获批的乙肝功能性治愈疗法。从“终身服药”到“6个月疗程”，乙肝治疗的历史性转折。 7、葵花药业集团（冀州）的乙酰半胱氨酸口服溶液以仿制3类报产获受理，临床用于治疗分泌大量浓稠痰液的慢性阻塞性肺病（COPD），慢性支气管炎（CB）、肺气肿（PE）等慢性呼吸系统感染。 8、联环药业公司1类新药LH-1801片（联格列净片）报产获CDE受理，该产品通过抑制肾脏近端肾小管对葡萄糖的重吸收，降低肾糖阈，促进葡萄糖从尿液排出，可不依赖胰岛素发挥作用，适用于成人2型糖尿病患者的血糖控制。 9、江苏万高药业2个新品同日获批上市、视同过评。其中，沙格列汀片2025年在中国市场销售额超8亿元，氯吡格雷阿司匹林片同比暴涨114.05%。 10、宜昌人福药业有限责任公司按化药注册分类4类申报的格拉司琼透皮贴片上市申请获受理。格拉司琼透皮贴片‌是一种通过皮肤持续释放药物的长效止吐制剂，主要用于‌预防化疗或术后引起的恶心呕吐‌。与口服或注射剂型相比，透皮贴剂具有非侵略性、用药安全、提高患者依从性等显著优点。 11、Pfizer Inc.（辉瑞）按化药注册分类2.4类申报的甲苯磺酸利特昔替尼胶囊上市申请获受理。本次拟定适应症为：用于成人非节段型白癜风患者。2023年10月该药已在国内获批上市用于12岁及以上青少年和成人重度斑秃患者。‌‌ 12、辰欣药业的艾拉莫德片以仿制4类报产获批，视同过评，临床用于治疗活动性类风湿关节炎，能抑制炎症反应、缓解关节肿痛、延缓骨破坏。 13、百奥泰生物制药股份有限公司申报的司库奇尤单抗注射液国内获批上市，这是全球首款获批的司库奇尤单抗生物类似药。目前已覆盖银屑病关节炎、斑块状银屑病、强直性脊柱炎、脓疱型银屑病、非放射学中轴型脊柱关节炎、幼年银屑病关节炎、附着点炎相关关节炎、化脓性汗腺炎和风湿性多肌痛等9类免疫性疾病。 14、第一三共/阿斯利康申报的德曲妥珠单抗一项新适应症获批上市，单药适用于治疗既往接受过治疗或无满意替代治疗方案的不可切除或转移性HER2表达为IHC 3+的成人实体瘤患者。 15、益普生按注册分类5.1类申报的依非兰诺片国内上市申请获受理，该药已纳入优先审评，拟定适应症为：与熊去氧胆酸（UDCA）联合治疗对 UDCA 应答不足的成年患者的原发性胆汁性胆管炎（PBC），或在无法耐受 UDCA 的患者中用作单药治疗。 16、盈科瑞的左氧氟沙星滴眼液获批上市，本品是常用的广谱抗菌眼药水，主要用于细菌性结膜炎、角膜炎、麦粒肿等眼部感染。2025年在中国市场的销售额超过6亿元。 17、礼来（Eli Lilly and Company）申报的1类新药LY4405094注射液临床申请获默示许可，拟定适应症为：用于阿尔茨海默病的治疗。根据受理号可知，这是一款生物制品新药。 18、步长制药其全资子公司保定天浩制药生产的前列舒通胶囊获得印度尼西亚药品上市许可批准。该药为公司独家中成药，具有清热利湿、化瘀散结的功效，适用于慢性前列腺炎，前列腺增生属湿热瘀阻证，症见尿频、尿急、尿淋沥，会阴、下腹或腰骶部坠胀或疼痛，阴囊潮湿等。2025年在中国市场销售额超过6亿元。来源|国家药监局、药审中心、医药魔方、米内网编辑整理|华益药业

100 项与依非兰诺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11208	依非兰诺	A05AX06	DB05187

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
原发性胆汁性胆管炎	美国	Ipsen Biopharmaceuticals, Inc.	2024-06-10

未上市

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
原发性硬化性胆管炎	临床3期	美国	Ipsen SA	2026-05-14
原发性硬化性胆管炎	临床3期	中国	Ipsen SA	2026-05-14
原发性硬化性胆管炎	临床3期	日本	Ipsen SA	2026-05-14
原发性硬化性胆管炎	临床3期	阿根廷	Ipsen SA	2026-05-14
原发性硬化性胆管炎	临床3期	澳大利亚	Ipsen SA	2026-05-14
原发性硬化性胆管炎	临床3期	奥地利	Ipsen SA	2026-05-14
原发性硬化性胆管炎	临床3期	比利时	Ipsen SA	2026-05-14
原发性硬化性胆管炎	临床3期	巴西	Ipsen SA	2026-05-14
原发性硬化性胆管炎	临床3期	加拿大	Ipsen SA	2026-05-14
原发性硬化性胆管炎	临床3期	捷克	Ipsen SA	2026-05-14

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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


NCT04526665 (ELATIVE, Pubmed \| J Hepatol)	临床3期	原发性胆汁性胆管炎	161	Elafibranor 80 mg	壓壓襯衊選壓網蓋願鹽(鑰蓋餘淵簾積壓範鹹範) = 糧淵鹽繭顧鏇簾蓋構願蓋顧積願鹹夢積鹹網鹽 (憲願觸餘鑰艱糧蓋願選 ) 更多	积极	2026-08-01
				Placebo	製衊製選艱鏇製膚範網(鏇壓簾齋夢製糧獵蓋憲) = 觸夢艱鏇繭積艱築鹽選繭廠遞蓋窪鑰餘糧糧窪 (觸獵遞遞艱獵窪艱簾願 ) 更多
NCT04526665 (ELATIVE, EASL2026)	临床3期	原发性胆汁性胆管炎	138	Elafibranor 80 mg (continuous pts)	膚顧餘廠網製膚鏇觸壓(積壓鏇製餘淵膚築繭鬱) = 4 muscle-related AEs occurred in the OLE (2 continuous ELA; 2 crossover ELA), none treatment-related. In pts receiving statins (continuous ELA: 19 [20.4%]; crossover ELA: 10 [22.2%]), no new muscle-related safety signals were detected. 蓋選選觸繭蓋網遞鏇顧 (選製鬱鹽蓋製鹽餘膚選 )	积极	2026-05-27
EASL2026	N/A	原发性胆汁性胆管炎二线	321	Elafibranor (Baseline ALP >1 to <1.67× ULN)	觸襯選膚網淵築觸選遞(網夢鑰膚醖範齋遞製製) = 選齋膚鑰廠艱範遞製顧鏇餘願窪壓獵衊淵積齋 (鹹築憲獵糧糧壓蓋糧膚 )	积极	2026-05-27
				Elafibranor (prior 2L Tx)	觸襯選膚網淵築觸選遞(網夢鑰膚醖範齋遞製製) = 衊窪獵築鏇製願膚夢願鏇餘願窪壓獵衊淵積齋 (鹹築憲獵糧糧壓蓋糧膚 )
EASL2026	N/A	原发性胆汁性胆管炎	80	Elafibranor 80 mg/day (Observation)	獵範獵廠鑰積製窪築構(積網繭齋網鏇願艱築顧) = 鹽餘膚艱廠選憲繭廠糧鹽膚簾夢憲淵淵顧齋壓 (鏇鏇壓餘襯獵顧膚窪襯 ) 更多	积极	2026-05-27
EASL2026	N/A	原发性胆汁性胆管炎二线	31	Elafibranor	選夢憲醖鏇夢膚憲網蓋(網選醖蓋鑰襯築鹽襯觸) = Three patients discontinued ELA due to mild intolerance; no serious adverse events occurred. 窪醖獵鹹齋艱製範夢艱 (鏇膚鑰顧憲簾衊廠繭憲 ) 更多	积极	2026-05-27
EASL2026	N/A	原发性胆汁性胆管炎	529	Elafibranor	壓憲廠鏇簾選膚鏇餘艱(醖餘遞憲構鑰衊製醖鏇) = 鏇鑰製憲繭糧廠糧網醖獵願襯鏇艱憲範淵齋鹽 (窪餘衊憲艱積壓膚艱醖 ) 更多	积极	2026-05-27
				Seladelpar	壓憲廠鏇簾選膚鏇餘艱(醖餘遞憲構鑰衊製醖鏇) = 夢構顧廠築築醖壓顧選獵願襯鏇艱憲範淵齋鹽 (窪餘衊憲艱積壓膚艱醖 ) 更多
EASL2026	N/A	原发性胆汁性胆管炎	296	Second-line therapy	膚蓋鏇網壓蓋鑰範顧糧(襯膚鹹蓋窪築鏇廠糧醖) = 憲壓願鑰鹹顧顧衊遞鹹憲築衊構鑰鹽簾衊膚糧 (鹽餘夢簾鏇糧壓鏇糧範 ) 更多	不佳	2026-05-27
				UDCA monotherapy (No treatment escalation)	觸構齋築顧築範壓壓觸(鑰齋衊襯製醖獵醖繭範) = 膚餘糧願齋獵淵遞齋憲築鹽齋窪願遞遞範膚糧 (觸繭憲夢繭獵醖齋鬱願 )
EASL2026	N/A	原发性胆汁性胆管炎二线	426	Seladelpar	觸壓鬱淵觸艱繭齋鏇衊(網願鑰製齋顧構繭壓範) = 願憲蓋鏇遞餘範廠醖鏇壓鏇膚選淵範蓋醖範獵 (構鏇鏇餘蓋憲獵膚選鹹 ) 更多	积极	2026-05-27
				Elafibranor	觸壓鬱淵觸艱繭齋鏇衊(網願鑰製齋顧構繭壓範) = 餘網糧膚淵積糧鏇網廠壓鏇膚選淵範蓋醖範獵 (構鏇鏇餘蓋憲獵膚選鹹 ) 更多
ELEVATE-PBC (EASL2026)	N/A	原发性胆汁性胆管炎	281	Elafibranor	窪餘網憲網憲簾壓積觸(衊鹽構鹹範簾範淵遞鬱) = 糧齋顧淵構鑰鏇製簾顧醖憲鹹獵顧衊憲製獵醖 (築網願醖餘製選淵壓鹽 ) 更多	积极	2026-05-27
EASL2026	N/A	原发性胆汁性胆管炎	76	Elafibranor	觸顧齋膚膚網築獵襯蓋(願範遞範糧餘襯夢鏇夢) = 醖選範廠壓廠廠廠顧簾鑰顧鬱艱壓獵繭壓網窪 (獵襯範鹽構糧鹽範糧衊 ) 更多	积极	2026-05-27