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2026-04-14

申办/合作机构

Ipsen SA

NCT06730061

/ Active, not recruiting临床3期

A Phase III, Open-label, Single Arm Study to Investigate the Efficacy and Safety of Elafibranor 80 mg in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)

The purpose of this study is to find out about the safety and how well the study intervention (elafibranor) works in participants with PBC. The participants in this study will have confirmed PBC with inadequate response or intolerance to UDCA, which is a medication used in the management and treatment of cholestatic liver disease.
PBC is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis).
PBC may also be associated with multiple symptoms. Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. In this study all participants will receive a daily dose of elafibranor (the study intervention).
The main aim of this study is to determine if elafibranor reduces alkaline phosphatase (ALP) and total bilirubin levels. High ALP and bilirubin levels in the blood can indicate liver disease.
There will be 4 periods in this study: A screening period (up to 10 weeks) to assess whether the participant can take part. A treatment period (52 weeks) where all eligible participants will receive elafibranor. A variable treatment extension period (2-5 years) from End Of Treatment (EOT) period up to the commercial availability of elafibranor in Japan. A follow-up period (4 weeks) where participants' health will be monitored.
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a non-invasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (to measure stiffness of the liver). They will also be asked to fill in questionnaires. Each participant will be in this study for up to approximately 6 years

开始日期2025-01-16

申办/合作机构

Ipsen SA

NCT06383403

/ Active, not recruiting临床3期

A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.
Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms.
Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment).
The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.
There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.
Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).
They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).

开始日期2024-07-09

申办/合作机构

Ipsen SA

100 项与 Elafibranor 相关的临床结果

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100 项与 Elafibranor 相关的转化医学

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100 项与 Elafibranor 相关的专利（医药）

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130

项与 Elafibranor 相关的文献（医药）

2026-06-01·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

Understanding Pharmacokinetic-Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2024 to Better Manage the Risk of Drug Interactions With Concomitant Medications: A Review of Clinical Data From New Drug Applications

Review

作者: Owens, Katie ; Argon, Sophie ; Yu, Jingjing ; Ragueneau-Majlessi, Isabelle ; Wang, Yan

Objective:

This analysis aimed to provide a mechanistic understanding and an evaluation of the clinical relevance of pharmacokinetic drug-drug interactions (DDIs) associated with drugs approved by the Food and Drug Administration in 2024.

Methods:

Drug metabolism, transport, and absorption-based DDI data available in New Drug Applications (NDAs) of small molecular drugs approved (n = 34) was analyzed. The mechanism and clinical outcome of these interactions were characterized based on in vitro, in silico, and clinical data.

Results:

As objects, 11 drugs were identified as clinical substrates. Of these, 7 drugs were substrates of CYP3A, 3 of CYP2C9, one of CYP1A2, and one of CYP2C8, including the sensitive substrates vanzacaftor (CYP3A) and vorasidenib (CYP1A2). As precipitants, 6 drugs (acoramidis, cefepime/enmetazobactam, givinostat, lazertinib, mavorixafor, and resmetirom) were clinical inhibitors of CYP enzymes (2C8, 2C9, 2D6, 2E1, and 3A), with mavorixafor being a CYP2D6 strong inhibitor. Two drugs (elafibranor and tovorafenib) showed weak induction of CYP3A. Regarding transporter data, 3 drugs were substrates of transporters, including seladelpar (BCRP and OAT3), sulopenem (OAT3), and vadadustat (OAT1/3), and 8 drugs (arimoclomol, danicopan, givinostat, lazertinib, mavorixafor, resmetirom, vadadustat, and vazacaftor/tezacaftor/deutivacaftor) were inhibitors of transporters. All clinical DDIs with AUC changes ≥ 2-fold triggered labeling recommendations. Several DDIs with an AUC change <2 also had labeling recommendations, pertaining most often to the concomitant use of drugs with a narrow therapeutic index.

Conclusions:

Mechanistic DDI insights from newly approved therapies can be extrapolated to inform the management of commonly co-administered drugs, supporting a safer and more effective use of new drug products in the context of polypharmacy.

2026-02-01·Disease Models & Mechanisms

A small-molecule screen identifies that elafibranor links mechanical cues and Irf6-dependent epithelial differentiation

Article

作者: Yu, Emily P. Y. ; Golden, Brandi M. ; Liao, Eric C. ; Molteni, Helen L.

ABSTRACT:

The periderm is a transient epithelial layer with crucial roles in maintaining barrier integrity and preventing abnormal adhesions during midface development. Interferon regulatory factor 6 (IRF6) is a key genetic driver of periderm function. Zebrafish irf6 maternal-null embryos fail to form the periderm precursor epithelial population, termed the enveloping layer (EVL), resulting in embryonic rupture prior to gastrulation. We utilized this irf6 maternal-null model to perform a chemical screen and found that elafibranor, a dual PPARα/PPARδ agonist, delayed rupture and rescued irf6 maternal-null embryos to initiate gastrulation. Elafibranor treatment restored EVL cell-cell contacts, F-actin morphology and Zo1 localization at multiway junctions. Elafibranor also partially rescued expression of epithelial differentiation markers esrp1, tp63 and cebpb. Surprisingly, EVL structural changes preceded epithelial differentiation gene expression, suggesting that intercellular mechanical forces influence Irf6-mediated epithelial differentiation. Further, elafibranor-exposed wild-type zebrafish displayed characteristics of exacerbated adhesion, including axis shortening, craniofacial cartilage dysmorphology and elongated periderm microridges, as possible sequelae of apical epithelial constriction. These findings provide new insights into the complex interplay between tissue-level mechanical cues and transcriptional changes during early epithelial and embryonic development.

2026-01-01·Innere Medizin (Heidelberg, Germany)

Review

作者: Herta, Toni ; Berg, Thomas

Primary biliary cholangitis (PBC) is a chronic inflammatory, autoimmune-mediated liver disease that progresses to fibrosis and cirrhosis if left untreated. In addition to preventing complications, the management of burdensome symptoms, particularly pruritus, represents a key therapeutic goal. Ursodeoxycholic acid (UDCA) is the established first-line treatment; however, up to 40% of patients show an inadequate response and require second-line treatment. Bezafibrate, a pan-peroxisome proliferator-activated receptor (PPAR) agonist, has long been used off-label as an effective option to improve parameters of cholestasis and relieve pruritus. More recently, two new PPAR agonists, elafibranor (PPAR alpha/delta) and seladelpar (PPAR delta), have received conditional approval in Germany. Both demonstrated strong biochemical efficacy and a favorable safety profile in clinical trials. This article provides a comprehensive update on the diagnostics, risk stratification and treatment of PBC, with a particular focus on the role of novel PPAR agonists in second-line treatment. Practical strategies for the treatment of pruritus are also discussed. The aim is to support guideline-based care and to improve the treatment of patients with PBC through timely treatment adjustment and individualized treatment concepts.

308

项与 Elafibranor 相关的新闻（医药）

2026-02-25

·医药投资并购俱乐部

Ipsen SA 益普生

Ipsen SA 益普生公司在全球拥有超过 5,300 名员工。全球领导团队中，女性占比达到 55%。在 35 个国家设有直接机构。公司崇尚去风险化与聚焦，旨在解决长期困扰公司的Somatuline（兰瑞肽）专利悬崖问题。通过内部与外部创新丰富管线，例如利用重组神经毒素领域的全球领导地位，开发长效神经毒素。在罕见病和肿瘤领域推出了多款重要疗法，巩固了其在细分领域的领导地位；在治疗复杂罕见癌症，包括上皮样肉瘤、神经内分泌肿瘤（NETs）和肾细胞癌（RCC）。专注于改善特定儿童脑肿瘤患者的治疗效果。内部开发下一代神经毒素等核心技术。通过战略伙伴关系探索前沿治疗方式。利用端到端的研发能力，高效推进管线中 “first-in-class” 和 “best-in-class” 的分子，优先选择能快速惠及患者的项目。战略与商业模式 Ipsen 已彻底完成从一家混合型药企向纯粹的生物制药公司（Global Specialty Care Biopharma）的转型。通过果断剥离非核心的消费者健康业务（Consumer HealthCare），公司将全部资源集中在高壁垒、高附加值的三大核心领域：肿瘤、罕见病和神经科学。这种“做减法”的战略极大地提高了资本效率，使其核心运营利润率维持在35%左右的行业高位。外部创新（External Innovation）已取代内部发现，成为增长的第一引擎。不同于Big Pharma依赖庞大的内部研发中心，Ipsen 将自己定位为“资产整合者”。其战略逻辑利用强劲的资产负债表，通过许可引进（In-licensing）或并购（M&A）获取处于临床中后期（Mid-to-late stage）的资产。这种模式显著降低了早期药物发现的高失败率风险，同时利用其覆盖全球（特别是中、美、欧）的商业化网络实现资产价值最大化。 Ipsen 强调“全球化规模，本地化聚焦”。特别是在美国市场，Ipsen 正在积极扩张其商业足迹，以承接新购入资产（如Iqirvo和Bylvay）的落地。Ipsen的战略愿景并非追求全覆盖，而是在细分市场（Niche Market）做到全球第一，成为特定疾病领域的“特种部队”。核心领域肿瘤学 (Oncology)（占比约70%） Cabometyx（卡博替尼片） (RCC（肾细胞癌）/HCC（肝细胞癌）) 和 Onivyde（伊立替康脂质体注射液），胰腺癌，是当前的支柱。正在从传统的实体瘤向血液瘤（血液系统肿瘤）拓展（通过Epizyme（艾匹zyme公司）收购获得Tazverik他泽司他，并布局下一代免疫疗法ImCheck（艾姆克公司）的ICT01，针对γ9δ2 T细胞（伽马9德尔塔2 T细胞））罕见病 (Rare Disease) 建立了全球领先的罕见肝病（Rare Liver，罕见肝病）特许经营权。 • Iqirvo（艾启沃） (Elafibranor，伊拉非布兰)：治疗原发性胆汁性胆管炎 (PBC，原发性胆汁性胆管炎)，Best-in-class（同类最佳）潜力。 • Bylvay（蓓尔唯） (Odevixibat，奥德昔巴特)：覆盖 PFIC（进行性家族性肝内胆汁淤积症）和 ALGS（阿拉杰里综合征）等儿科胆汁淤积症。 • 罕见骨病： Sohonos（索霍诺斯） (Palovarotene，帕洛伐罗汀) 是全球首个获批用于 FOP（进行性骨化性纤维发育不良）的药物。神经科学 (Neuroscience) 围绕 Dysport（吉适） (肉毒毒素) 构建。不仅在医美（医疗美容），更在治疗性适应症（痉挛）上拥有极强统治力。正在开发长效版本（LANT，长效肉毒毒素候选药物）以对抗竞品。其他/前沿探索：通过与 Marengo 和 Skyhawk 的合作，探索 RNA剪接（RNA剪切）和 T细胞激活平台（T细胞激活平台），意图攻克“不可成药”靶点。图2：三大治疗领域的临床管线概览（来源：Ipsen-Integrated-annual-report-2024-1.pdf，第24页）技术平台肉毒毒素工程 (Toxin Engineering) Ipsen 在英国 Wrexham 拥有一流的研发与制造中心，专注于肉毒杆菌毒素（BoNT）的重组与修饰。这是公司的核心护城河。毒素生产涉及极高的生物安全标准和复杂的发酵工艺，极难被仿制。长效神经毒素（Long-Acting Neurotoxins）。其在研平台致力于通过蛋白工程技术，开发半衰期更长的重组毒素（如IPN10200），旨在减少患者注射频率，直接对标艾伯维的Botox。 RNA 剪接调节平台 (RNA Splicing)：通过与 Skyhawk Therapeutics 的合作，Ipsen 进入了小分子靶向RNA的领域。该技术旨在纠正神经系统罕见病中的RNA错误剪接，这为Ipsen在肉毒毒素之外，打开了治疗神经退行性疾病（如亨廷顿舞蹈症等）的新窗口。 T细胞重编程平台 (T-Cell Engagers)：通过与 Marengo Therapeutics 的合作，引入 TriSTAR 平台。该技术不同于传统的CAR-T或双抗，它通过特异性激活Vβ T细胞亚群来攻击“冷肿瘤”。这标志着Ipsen的技术触角延伸至下一代免疫肿瘤学。病毒载体技术 (Viral Vectors)：针对罕见病基因治疗的递送系统探索。总结： Ipsen 的技术平台策略是实用主义的。它不追求拥有所有底层技术，而是通过掌握核心制造工艺（毒素、缓释制剂）确立防守优势，同时通过灵活的BD接入前沿技术（RNA、免疫平台）以博取未来的爆发。核心产品产品组合协同性强： Dysport、 Somatuline提供稳定现金流（合计20亿欧元/年），Iqirvo、Bylvay贡献长期增量，Cabometyx主导肿瘤领域增长。2. 中国市场成关键变量：多款产品纳入医保，渗透率快速提升，成为全球增长核心极。3. 壁垒支撑估值：独家适应症、技术工艺、临床数据构建核心竞争优势，保障长期商业化价值。 Bylvay® (odevixibat) 全球推出的首款用于进行性家族性肝内胆汁淤积症（PFIC）的治疗药物。已获批用于治疗 Alagille 综合征相关的胆汁淤积性瘙痒（美国），并在欧洲以 Kayfanda® 品牌名上市。 IQIRVO® (elafibranor) 作为首款原发性胆汁性胆管炎（PBC）一线疗法，在美欧加速获批。其全球上市确立了益普生在罕见胆汁淤积性肝病领域的领导地位。 Onivyde® (irinotecan) NALIRIFOX 在美国推出，作为转移性胰腺腺癌（mPDAC）成人患者的一线治疗。有望成为该领域新的标准治疗方案，为患者提供更优选择。 Somatuline®（Lanreotide）长效生长抑素类似物，GEP-NET治疗一线标杆，肽自组装凝胶剂型，无需冷链、可自我注射，GEP-NET领域中位PFS 32.8个月（显著优于竞品奥曲肽微球）。2024年全球销售额12亿欧元，中国市场销售额8亿元（+25% YoY），医保覆盖后渗透率加速提升。全球SSA市场份额40%，凭借剂型与疗效优势，持续追赶诺华（58%份额） Dysport®（AboBoNT-A）全球第二大A型肉毒毒素品牌，神经肌肉治疗与医美领域双栖现金牛，工艺壁垒极高。无血清发酵工艺构建技术壁垒，扩散半径适中（3cm），适配肢体痉挛与面部除皱，免疫原性低。2024年全球销售额8亿欧元，新兴市场（中国、东南亚）增速超15%；市场份额约25%，性价比优于保妥适。拓展儿童脑瘫、下尿路障碍新适应症，研发长效制剂提升依从性 Iqirvo®（Elafibranor）首个获批的PPARα/δ双重激动剂，Ipsen未来5年核心增长引擎，填补PBC二线治疗近十年空白。双重激活PPAR受体，调节胆汁酸代谢、抗炎抗纤维化，瘙痒症状改善优于传统FXR激动剂。ELATIVE研究中，63%患者ALP降低≥40%，51%患者瘙痒评分改善≥30%，不良反应停药率＜5%，耐受性优异。全球PBC患者20-30万人，2029年销售额预计超10亿美元；同步拓展NASH、PSC适应症，延长生命周期。 Bylvay®（Odevixibat）首创IBAT抑制剂，儿科罕见病领域独家性产品，拥有罕见病优先审评券（PRV）战略价值。选择性抑制回肠胆汁酸重吸收，降低肝脏毒性，不影响脂溶性维生素吸收，适配儿童患者。全球唯一PFIC治疗药物、首个ALGS瘙痒治疗药物，患者忠诚度100%，无替代疗法竞争。儿科罕见病定价弹性大，2029年全球销售额预计8亿美元；胆道闭锁适应症进入III期，进一步打开增长空间。 Cabometyx®（Cabozantinib）多靶点TKI，晚期肾癌一线联合免疫标准疗法，Ipsen肿瘤管线核心支柱。抑制MET、VEGFR等9个靶点，调节肿瘤微环境，与免疫治疗协同增效，降低进展/死亡风险。CheckMate 9ER研究中，联合纳武利尤单抗使晚期RCC中位PFS达16.6个月（vs 对照组8.3个月），ORR 55%。2024年全球销售额12亿欧元，2029年预计超15亿欧元；拓展肝癌、神经内分泌肿瘤适应症，联合用药延长生命周期。核心在研管线 IPN10200 (LANT，肉毒素)：处于 Phase III 准备阶段。目标是在医美（眉间纹）和治疗（痉挛、偏头痛）领域替代现有短效毒素。这是 Ipsen 最大的潜在重磅产品之一。 Bylvay (IBAT抑制剂，治疗胆道闭锁 - BA)：正在进行 Phase III (BOLD) 试验。胆道闭锁的患儿数量远多于 PFIC 和 ALGS，若获批，将显著提升 Bylvay 的销售峰值潜力. Fidrisertib (FOP)： Phase II (FALKON) 试验中。作为 ALK2 激酶抑制剂，旨在阻断 FOP 的病理核心——骨形态发生蛋白（BMP）信号通路的过度激活，有望比第一代药物 Sohonos 更有效. ICT01 (ImCheck)：即将进入注册性临床。针对一线不适合化疗的 AML 患者，有望填补巨大的临床空白。 Tovorafenib (pLGG)：正在进行 Phase III (FIREFLY-2) 试验，针对一线需要治疗的儿童低级别胶质瘤，旨在替代传统的化疗方案. IPN01194 / IPN01195：针对 MAPK 通路的下一代抑制剂，旨在克服现有 BRAF/MEK 抑制剂的耐药性问题，用于治疗实体瘤. 重点交易合作伙伴合作形式领域核心资产/技术交易结构与战略逻辑 ImCheck Therapeutics 2025年12月收购 (Acquisition) 肿瘤 (IO) ICT01 (γ9δ2 T细胞激活剂) 结构：€3.5亿首付 + 里程碑付款，总额可达€10亿。逻辑：获得 First-in-class 的免疫治疗资产，补充血液肿瘤管线。这是对“非传统T细胞疗法”的一次豪赌，旨在突破 PD-1/L1 的治疗瓶颈. Day One Biopharmaceuticals 2024年7月许可引进 (In-licensing) 肿瘤 (儿科) Tovorafenib (pLGG) 结构：$1.11亿首付（含股权投资） + 里程碑。逻辑：获取除美国以外的全球权益。利用 Ipsen 强大的欧洲及全球商业网络变现，Day One 则保留美国市场。这是典型的“地域互补”型合作. Marengo Therapeutics 2024年6月扩大战略合作 (Strategic Partnership) 肿瘤 (实体瘤) TriSTAR 平台 (TCEs) 结构：高达$12亿的里程碑付款。逻辑：针对“冷肿瘤”的攻坚战。通过特异性激活 Vβ T 细胞，解决传统免疫疗法无效的难题。这属于“技术平台型”合作，旨在储备未来资产. Skyhawk Therapeutics 2024年4月研发合作 (R&D Collaboration) 神经科学 RNA 剪接调节小分子结构：高达$18亿的里程碑付款。逻辑：布局未来技术。利用小分子靶向 RNA，治疗难以成药的神经系统罕见病，补充毒素以外的神经管线，实现技术路线的多元化. 重点案例 1：收购 Albireo (2023年 M&A) • 交易金额：约 9.52亿美元（含预付款和CVR）。 • 核心资产： Bylvay (Odevixibat) 及整个胆汁酸调节剂管线。 • 交易解读：这是一笔教科书式的**“补强收购 (Bolt-on)”**。￮战略契合：完美契合 Ipsen 的罕见病战略。￮协同效应： Ipsen 利用其现有的全球消化/肝病销售网络，迅速放大了 Bylvay 的商业价值。￮价值判断：直接确立了 Ipsen 在儿科罕见肝病领域的全球统治地位。重点案例 2：与 Day One Biopharmaceuticals 的独家许可 (2024年 Licensing) • 涉及资产： Tovorafenib (泛RAF抑制剂，治疗儿科脑胶质瘤 pLGG)。 • 交易结构： 1.11亿美元首付款 (含股权投资) + 约 3.5亿美元里程碑 + 销售分成。 • 交易解读：典型的**“地域互补 (Geographic Split)”** 模式。￮逻辑： Day One 保留美国权益，Ipsen 获得除美国以外的全球权益。￮双赢： Day One 这种小型 Biotech 难以在欧洲建立商业团队，而 Ipsen 在欧洲拥有强大的肿瘤销售网络。这是一笔低风险、高杠杆的交易，直接变现了 Ipsen 的渠道价值。价值判断罕见病（Bylvay/IQIRVO）与神经科学（Dysport）提供中短期增长；肿瘤领域通过 Onivyde 一线拓展、MAPK 管线与外部引入资产形成催化剂。 END 扫码关注医药投资并购俱乐部获得更多讯息

并购申请上市

2026-02-23

·研发客

益普生公布2025年业绩

在肿瘤（4.1%[1]）、罕见病（102.5%[1]）和神经科学（9.7%[1]）三个治疗领域增长的推动下，以固定汇率计算，2025财年总销售额增长10.9%[1]，以报告汇率计算增长8.1%；索马杜林®销售额增长4.3%[1]，除索马杜林外其他产品实现了销售额双位数增长（14.2%[1]） 2025财年核心营业利润为12.94亿欧元，以报告汇率计算增长16.7%，核心营业利润率占总销售额的35.2%，增长2.6个点 2025年研发管线持续推进，包括重大监管和临床里程碑的推动，整合多项具有全球权益和创新模式的临床前资产，以及收购ImCheck Therapeutics获得中期候选药物 2026年有望实现五项重大监管和临床里程碑，并将公布IPN10200在医美适应症中的完整数据结果公布2026年全年财务指引[2]，以固定汇率计算，总销售额增长超过13.0%[3]，核心营业利润率超过总销售额的35.0%，基于除索马杜林外产品组合实现加速增长，同时由于兰瑞肽仿制药生产方面的挑战导致索马杜林销售额增长的假设。巴黎2026年2月13日-- 全球特药领域生物制药公司益普生（Euronext: IPN; ADR: IPSEY）今日公布了2025全年（财年）和2025年第四季度的财务业绩。益普生首席执行官David Loew表示："益普生在2025年实现了强劲的销售额和利润增长。我们在三个治疗领域继续深耕，其中Iqirvo的表现尤为突出。我们推进了多个研发管线项目，并通过有针对性的业务开发，包括收购ImCheck Therapeutics，进一步加强了创新引擎。我们还在同类首创差异化长效重组分子IPN10200中取得了充满希望的概念验证结果。 2026年，我们有望再次实现销售额的双位数增长，这将得益于整个产品组合的增长提速，以及在兰瑞肽仿制药生产受限的背景下，索马杜林的市场前景进一步改善。我们预计今年将实现五项监管和临床里程碑，并进一步落实我们的外部创新战略。" 2026年全年指引及中期展望益普生为2026财年制定了以下财务指引：以固定汇率计算，总销售额增长超过13.0%。基于2026年1月的平均汇率水平，预计汇率将对总销售额产生约2%的不利影响。核心营业利润率超过总销售额的35.0%，其中已计入因预期的早期和中期外部创新机会所产生的额外研发费用。总销售额和核心营业利润率指引基于如下假设：除索马杜林外的产品组合销售额加速增长，以及因兰瑞肽仿制药生产受限带来的索马杜林销售额增长。该指引排除了潜在的后期（Ⅲ期临床开发或之后）业务开发交易的任何影响。基于对长期假设（包括竞争强度和产品生命周期考量）的持续评估，益普生已不再将Onivyde和达唯珂实现5亿欧元销售峰值作为目标。基于索马杜林因兰瑞肽仿制药持续生产受限所带来的更高销售预期，以及更广泛产品组合的业绩表现，益普生对2027年中期目标充满信心，认为2023~2027年间实现总销售额年均增长率[5]至少7%，并在2027年实现核心营业利润率至少占总销售额的32%[6]。研发管线进展 2025年，益普生在不同产品组合实现多项重要的监管和临床里程碑，反映了三个治疗领域的研发管线持续推进。 2025年第一季度，欧洲药品管理局（EMA）受理了用于治疗儿童低分化胶质瘤的口服Ⅱ型RAF-激酶抑制剂tovorafenib的监管申报文件。 2025年5月，益普生在欧洲肝脏研究学会（EASL）大会上公布了Iqirvo®（elafibranor）ELMWOOD研究的Ⅱ期数据，证明了在原发性硬化性胆管炎患者的12周治疗中具有良好安全性特征和剂量依赖性疗效。原发性硬化性胆管炎是一种医疗需求高度未满足的疾病。 2025年7月，基于Ⅲ期CABINET试验的积极结果，欧盟委员会批准Cabometyx®（cabozantinib）用于治疗有既往治疗史的晚期神经内分泌肿瘤（NETs）。 2025年9月，益普生公布了IPN10200在医美领域LANTIC Ⅱ期临床的积极数据，显示该产品具有差异化的长效临床特征。年内，益普生还启动了IPN10200用于颈部张力障碍的Ⅱ期研究，这是该长效重组分子跨治疗和医美适应症的全球开发计划中的第四项临床研究。 2025年12月，益普生宣布，关于将fidrisertib用于进行性骨化性纤维发育不良（FOP）的关键性Ⅱ期FALKON试验未达到主要终点，研究随后终止；fidrisertib总体耐受性良好，未发现安全性问题。此外，益普生启动了多项肿瘤I期临床研究，包括RAF抑制剂IPN01195、抗体偶联药物IPN60300和T细胞激活剂IPN01203，进一步强化了益普生的肿瘤靶向药物研发管线。外部创新 2025年12月，益普生通过收购ImCheck Therapeutics进一步扩展了肿瘤免疫治疗产品组合。ImCheck Therapeutics是一家致力于开发下一代肿瘤免疫疗法的生物技术公司，产品包括IPN60340（ICT01），这是一种靶向BTN3A的同类首创单克隆抗体，目前处于Ⅰ/Ⅱ期开发阶段，计划于2026年启动Ⅱb/Ⅲ期研究。IPN60340有望在一线不适合强化治疗的急性髓系白血病（一种常见于老年人的侵袭性血癌）患者中，通过联合用药方案，形成新的治疗标准。在2025年美国临床肿瘤学会年度会议上口头报告的Ⅰ/Ⅱ期EVICTION试验的期中数据显示，ICT01联合维奈克拉和阿扎胞苷（Ven - Aza）治疗获得了令人鼓舞的高缓解率。在这项单臂试验中，与历史标准治疗数据相比，新诊断患者的所有分子亚型（包括对标准治疗[Ven-Aza]反应较差的亚型）的治疗缓解率几乎提高了一倍。2026年1月，益普生还宣布美国FDA已授予IPN60340突破性疗法认定，用于一线不适合强化治疗的急性髓系白血病。 2025年12月，益普生通过另外两项有针对性的业务开发和研究合作，进一步加强了肿瘤学和早期研发管线。益普生与先声再明（Simcere Zaiming）签署独家授权协议，获得SIM0613，一款靶向LRRC15的抗体偶联药物，在大中华区以外地区的权益。益普生还宣布与蒙特利尔大学和IRICoR达成一项新的研究合作和选择权协议，该协议涵盖两个处于发现阶段的研究项目，重点关注对MAP激酶通路具有互补作用的新型抑制途径。 2026年即将达到的里程碑益普生预计2026年产品组合将迎来多项关键里程碑，包括： Tovorafenib（FIREFLY-1）-针对儿童低分化胶质瘤的欧洲监管决策蓓尔唯（BOLD）- 胆管闭锁关键性Ⅲ期试验的数据读出 Iqirvo（ELSPIRE）- 原发性胆汁性胆管炎关键性Ⅲ期试验的数据读出吉适（BEOND）- 慢性和发作性偏头痛关键性Ⅲ期试验的数据读出 IPN10200（LANTIC）- 外眦纹和抬头纹Ⅱ期试验的数据读出这些里程碑进一步加强了益普生致力于推进创新疗法，为全球患者扩大治疗选择的承诺。 IPN10200的Ⅱ期LANTIC研究的完整数据预计将于2026年上半年在即将召开的大会上公布，研究结果此前已显示出积极的同类首创、差异化长效临床特征，并支持启动Ⅲ期研究。 Galderma仲裁事项 2026年1月，国际商会（ICC）仲裁庭已作出有利于益普生的最终裁决，驳回了Galderma就益普生终止研发协议提起的仲裁请求。仲裁庭确认了益普生对在美学领域的临床阶段毒素项目的全部权利，包括IPN10200。益普生将继续评估所有方案，以最大限度地发挥长效方案的价值。环境、社会和治理 2025年，益普生在推进宏伟的可持续发展战略方面采取了重要措施，持续将可持续发展融入公司运营和决策中。从减少环境足迹到提高患者可及性，再到发扬企业文化，益普生进一步加强对造福患者、员工、社区和地球的承诺。益普生在多个环境目标方面取得了良好进展，包括：范围1和范围2的温室气体排放量减少54%（与2019年基线相比）范围3的排放量减少16%，完全符合我们的2030年目标（与2019年基线相比）益普生全球用电现在100%来自可再生能源在"未来车队"项目的影响下，截至2025年，公司车队中电动汽车占比已达55%。益普生因在环境行动和透明度方面的最佳实践，以及对环境依赖性、风险和机遇的全面理解，成功斩获CDP A级评级。益普生很自豪地成为首批在执行领导团队内实现完全性别均等的生物制药公司之一，目前全球领导团队中女性占比达53%。说明除非另有说明，否则本报告中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2025年12月31日之前的12个月（2025财年）和2025年12月31日之前的3个月（2025年第四季度），而数据对比的对象为2024年12月31日之前的12个月（2024财年）和2024年12月31日之前的3个月（2024年第四季度）。除非另有说明，否则评论基于2025财年的业绩。关于益普生益普生是一家全球性的生物制药公司，专注于在肿瘤学、罕见病和神经科学三个治疗领域为患者提供革新型药物。我们的研发管线由内部和外部创新推动，并由近100年的开发经验以及位于美国、法国和英国的全球中心提供支持。我们的团队遍布全球40多个国家，在世界各地均有合作伙伴，这使我们能够为100多个国家的患者提供药物。益普生在巴黎（泛欧交易所：IPN）上市并通过赞助的I级美国存托凭证项目（ADR：IPSEY）在美国上市交易。更多信息，请访问ipsen.com。关于益普生中国益普生集团于1992年进入中国，于2021年在上海成立中国区总部，并于2022年根据集团业务变动，同步剥离多元健康业务，专注于特药领域，针对三大疾病领域（肿瘤、罕见病、神经科学），益普生中国将持续推出创新治疗方案以满足中国患者亟待解决的治疗需求。 [1] 以固定汇率（CER）计算，即通过应用前一时期使用的汇率重新计算相关时期的业绩，排除任何外汇影响。 [2] 排除潜在后期（Ⅲ期临床开发或后续开发）外部创新交易的任何影响。 [3] 基于2026年1月的平均汇率水平，预计货币汇率将对总销售额产生约2%的不利影响。 [4] 合并业绩摘录。公司审计师对合并财务报表进行了审查。 [5] 以固定汇率计算的2023~2027复合年均增长率（CAGR） [6] 排除潜在后期（Ⅲ期临床开发或后续开发）外部创新交易的任何影响。

临床3期并购财报申请上市

2026-02-19

·PRNewswire

Devonian Reports Human Liver-on-a-Chip Data Demonstrating Disease-Relevant Modulation of MASH by Thykamine™, with Dose-Dependent Anti-Fibrotic and Anti-Inflammatory Effects

QUEBEC, Feb. 19, 2026 /PRNewswire/ - Devonian Health Group Inc. ("Devonian" or the Company) (TSXV: GSD) (OTCQB: DVHGF) today announced positive results from a follow-up preclinical study evaluating Thykamine™ in a human metabolic-associated steatohepatitis (MASH) model using PhysioMimix® Liver-on-a-Chip platform. The study was conducted by CN Bio Innovations, Cambridge, UK. Importantly, the study demonstrates that Thykamine™ exerts dose-dependent effects on key pathological hallmarks of MASH, including fibrosis and inflammation, in a physiologically relevant human liver system. These results represent a critical translational bridge between Devonian's previously disclosed efficacy in the mouse STAM® MASH model and a predictive human microphysiological model. Study Design and Dosing Thykamine™ was evaluated at four low concentrations (0.025, 0.05, 0.1, and 0.2 mg/mL) over a 14-day treatment period in a dynamic, triple-cell liver model incorporating primary human hepatocytes, Kupffer cells, and hepatic stellate cells under continuous microfluidic flow to induce a MASH phenotype. Elafibranor, a clinically advanced compound previously evaluated in MASH clinical trials3,4, was included as a reference positive control (20 uM), alongside a vehicle control. Key Findings Demonstrating Impact on the MASH Phenotype Disease-relevant reduction in fibrosis: Thykamine™ produced a clear, dose-dependent reduction in fibrosis-associated biomarkers, including pro-collagen and TIMP-1, with the strongest effects observed at 0.1 and 0.2 mg/mL. These markers are central to extracellular matrix deposition and fibrotic progression in MASH. Suppression of collagen accumulation: Confocal imaging confirmed a significant decrease in Type I collagen deposition, indicating attenuation of one of the core structural features of fibrotic MASH. At higher doses, the magnitude of collagen reduction was greater than that observed with Elafibranor under identical experimental conditions. Modulation of inflammatory signaling: Thykamine™ induced a dose-dependent reduction in pro-inflammatory cytokines IL-6 and IL-8 at later time points, reflecting an effect on inflammatory pathways that contribute to hepatocellular injury and disease progression in MASH. Preservation of liver cell health: LDH levels remained low throughout the study, with no evidence of drug-induced liver injury. Observed changes in albumin production were not associated with cytotoxicity and will be further investigated. "These findings show that Thykamine™ does more than modulate individual biomarkers—it impacts the core biological processes that define MASH, including fibrosis and inflammation," said Dr. André P. Boulet, PhD, Chief Executive Officer of Devonian. "Together with our previously reported mouse STAM® data, this study strengthens the translational rationale for Thykamine™ as a potential disease-modifying therapeutic candidate" added Dr Boulet. The PhysioMimix® Liver-on-a-Chip platform recapitulates key aspects of human MASH pathology by combining multi-cellular liver architecture with physiological flow. The consistent activity of Thykamine™ across in vivo and human organ-on-a-chip models supports its differentiated profile among emerging MASH therapeutics. Devonian plans to advance additional preclinical studies to further characterize Thykamine™'s disease-modifying potential and support continued development in MASH and other fibrotic diseases. About NAFLD/MASH1,2 Nonalcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease with a worldwide prevalence of 20-30%. It is represented by fat accumulation in the liver, a condition that is commonly associated with features of the metabolic syndrome (MetS), such as obesity, type 2 diabetes, dyslipidemia, and hypertension. NAFLD progresses to metabolic dysfunction-associated steatohepatitis (MASH), the hallmarks of which are inflammation, hepatocellular ballooning, and subsequent worsening fibrosis. Left untreated, MASH can ultimately progress to cirrhosis of the liver and hepatocellular carcinoma, liver failure and death. The global Metabolic Dysfunction-Associated Steatohepatitis (MASH) treatment market is experiencing rapid growth, driven by rising rates of obesity, type 2 diabetes, and metabolic syndrome5. According to DataM Intelligence6, the market was valued at $7.87 billion in 2024 and is projected to reach $31.76 billion by 2033, growing at a 17.7% CAGR from 2025 to 2033. About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian's SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large Phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are covered by patents issued in several North American, European and Asian countries. About CN Bio CN Bio is on a mission to accelerate drug discovery. As a leading Organ-on-chip (OOC) company, the team is transforming how human-specific efficacy and safety data are generated. CN Bio's human organ models deepen the understanding of disease mechanisms, help uncover new drug targets and enable development of novel, safe, and effective therapeutics. The Company's portfolio of products and services offer deeper and more valuable insights into how drugs are predicted to perform in patients to greatly reduce risk, time and costs. Based in Cambridge (UK), CN Bio leverages over a decade of experience and expertise in bringing single and multi-organ OOC based microphysiological systems (MPS) to the market. The Company's ground-breaking benchtop PhysioMimix® Core System accurately mimics human physiology using advanced, predictive in vitro human organ models, relieving dependence on animals in line with regulatory change. The power of PhysioMimix® technology has been harnessed by 16 leading pharmaceutical companies and is recognized by the US FDA, resulting in the first co-publication between a drug regulator and MPS provider, plus acceptance into the FDA's ISTAND program. PhysioMimix data has informed several regulatory filings, including a regulatory world first in 2023 when the Company supported a successful filing to initiate clinical testing for the treatment of metabolic liver disease. To find out more about how CN Bio is pioneering faster, more accurate drug discovery, please visit: or follow the company on LinkedIn @CN Bio. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune fibroinflammatory disease with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription drugs for the treatment of fibroinflammatory autoimmune diseases including but not limited to atopic dermatitis, radiodermatitis and ulcerative colitis. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare LP, focused on selling prescription pharmaceutical products in Canada, under licenses from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Quebec, Canada where it owns a state-of-the art extraction facility. Devonian is traded publicly on the TSX Venture Exchange (the " Exchange") ( TSXV: GSD) and currently quoted on the OTCQB Venture Market ( OTCQB: DVHGF). For more information, visit . References Ekstedt M, Nasr P and Kechagias S. Natural History of NAFLD/NASH. Curr Hepatology Rep. 16:391-397, 2017. Pierantonelli I. and Svegliati-Baroni G. Nonalcoholic Fatty Liver Disease: basic Pathogerenic Mechanisms in the Progression from NAFLD to NASH. Transplantation, 103(1): p e1-e13, 2019. Ewsome PN and Loomba R. Therapeutic horizons in metabolic dysfunction–associated steatohepatitis. J Clin Invest.135(13):e186425; 2025. GENFIT: Announces Results from Interim Analysis of RESOLVE-IT Phase 3 Trial of Elafibranor in Adults with NASH and Fibrosis, May 11, 2020 Jeffrey V. Lazarus JV, Brennan PN,Mark HE, et al. A call for doubling the diagnostic rate of at-risk metabolic dysfunction-associated steatohepatitis.The Lancet Regional Health – Europe, 54:101320, 2025. NASH/MASH Treatment Market Size, Share, Growth Insights and Forecast 2025-2033. DataM Intelligence, November 2025. Cautionary Note Regarding Forward-Looking Statements All statements, other than statements of historical fact, contained in this press release including, but not limited to those relating to the Common Shares consolidation; the anticipated post-consolidation trading price of the Common Shares; the potential impact of the consolidation on investor interest and liquidity; the ability to satisfy minimum price or other listing requirements of U.S and other stock exchanges; the impacts in perceived trading price following the consolidation; the ability of the Company to maintain compliance with regulatory requirements following the consolidation; and generally, the above "About Devonian" paragraph, all of which essentially describes the Company's outlook, constitute "forward-looking information" or "forward-looking statements" within the meaning of certain securities laws (collectively, "forward-looking statements"), and are based on expectations, estimates and projections as of the time of this press release. Such forward-looking statements may be identified by the use of words such as "intends", "believes", "expects", or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", or "will" be taken, occur or be achieved. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management's expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release. 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临床2期临床3期临床结果

100 项与 Elafibranor 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11208	Elafibranor	-	DB05187

研发状态

批准上市

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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

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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	-	Ipsen SA	2026-04-14
纤维化	临床3期	比利时	Genfit SA	2016-02-25
代谢功能障碍相关脂肪性肝炎	临床3期	比利时	Genfit SA	2016-02-25
肝功能衰竭	临床2期	德国	Ipsen Bioscience, Inc.	2023-01-18
代谢功能障碍相关的脂肪肝病	临床2期	荷兰	Genfit SA	2019-08-16
肝损伤	临床2期	比利时	Genfit SA	2012-09-11
胰岛素抵抗	临床2期	法国	Genfit SA	2010-12-21
2型糖尿病	临床2期	波斯尼亚和黑塞哥维那	Genfit SA	2010-12-01
2型糖尿病	临床2期	拉脱维亚	Genfit SA	2010-12-01
2型糖尿病	临床2期	摩尔多瓦	Genfit SA	2010-12-01

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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


NCT05627362 (ELMWOOD, Pubmed \| J Hepatol)	临床2期	原发性硬化性胆管炎 alkaline phosphatase (ALP)	68	Elafibranor 80 mg	淵窪築構醖鏇鏇鏇膚廠(獵選醖觸艱鹹蓋鹽構襯) = 繭餘範觸鹽蓋糧窪遞製醖網築憲鏇壓膚範壓衊 (遞衊憲簾壓餘夢廠積選 ) 更多	积极	2025-05-01
				Elafibranor 120 mg	淵窪築構醖鏇鏇鏇膚廠(獵選醖觸艱鹹蓋鹽構襯) = 積簾築繭觸積獵簾鹽鏇醖網築憲鏇壓膚範壓衊 (遞衊憲簾壓餘夢廠積選 ) 更多
NCT05627362 (ELMWOOD, NEWS) 人工标引	临床2期	原发性硬化性胆管炎	68	elafibranor	鑰餘壓窪選憲壓鏇觸窪(衊齋淵獵範夢遞觸廠襯) = Data from ELMWOOD demonstrated a positive safety and tolerability profile. 襯壓繭觸艱廠壓範鑰夢 (繭觸獵壓壓鹽廠繭窪醖 ) 更多	积极	2025-04-25
				Placebo
NCT04526665 (ELATIVE, CTgov)	临床3期	原发性胆汁性胆管炎	161	Placebo	夢顧憲鹽窪齋醖選憲鹽 = 簾襯構鑰壓鏇簾淵膚廠構獵窪積膚製鏇艱鏇齋 (醖膚製鏇願餘製鏇遞鹹, 齋蓋醖築築餘鏇餘蓋壓 ~ 淵襯衊壓艱繭願繭鬱網) 更多	-	2024-09-05
NCT04526665 (FDA_CDER) 人工标引	临床3期	原发性胆汁性胆管炎	161	IQIRVO 80mg Once Daily	構壓醖構憲壓廠衊顧選(壓鹽鹹鑰範獵淵廠願齋) = 膚製鑰窪壓憲選簾糧壓壓廠餘廠鹹廠廠夢網蓋 (糧衊鏇壓願選獵襯築顧 ) 更多	积极	2024-06-10
				Placebo	構壓醖構憲壓廠衊顧選(壓鹽鹹鑰範獵淵廠願齋) = 艱製膚醖鑰鏇蓋醖壓衊壓廠餘廠鹹廠廠夢網蓋 (糧衊鏇壓願選獵襯築顧 ) 更多
NCT04526665 (ELATIVE, EASL2024) 人工标引	临床3期	原发性胆汁性胆管炎	161	Elafibranor	積觸餘糧獵夢觸壓廠構(範淵遞鬱願艱鏇簾簾齋) = 鑰廠廠醖鑰遞廠網鑰構鏇鬱窪範窪構壓積鹽窪 (願壓積膚壓鹽艱鑰窪構 ) 更多	积极	2024-06-01
				Placebo	顧製鬱網艱膚壓齋夢鹹(範憲顧顧醖鏇淵構膚膚) = 襯繭襯餘壓餘繭壓鹹範艱蓋築衊製繭觸觸築窪 (鏇獵艱憲糧顧壓範夢廠 )
NCT04526665 (ELATIVE, Pubmed) 人工标引	临床3期	原发性胆汁性胆管炎	161	Elafibranor 80 mg	鬱憲鹹選餘淵繭簾觸觸(蓋齋積網窪積簾蓋獵簾) = 淵壓構積範顧壓積選觸糧選膚窪築醖鬱憲憲餘 (積艱鏇醖鹹鏇膚遞選鑰 ) 更多	积极	2024-02-29
				Placebo	鬱憲鹹選餘淵繭簾觸觸(蓋齋積網窪積簾蓋獵簾) = 齋蓋膚廠蓋憲餘壓夢積糧選膚窪築醖鬱憲憲餘 (積艱鏇醖鹹鏇膚遞選鑰 ) 更多
NEWS 人工标引	临床3期	原发性胆汁性胆管炎	161	elafibranor	顧願餘窪願膚艱壓顧製(齋醖繭鏇積築夢積鏇蓋): 3.0 更多	积极	2023-11-14
				placebo
NCT04526665 (ELATIVE, Biospace) 人工标引	临床3期	原发性胆汁性胆管炎	161	elafibranor 80mg	構窪夢選膚膚鹹廠憲淵(願齋醖鏇鏇網顧蓋廠蓋) = 範糧衊艱顧顧願繭廠願壓襯遞艱範獵鬱選簾範 (獵選鑰廠淵糧築構鹹築 )	积极	2023-09-20
				placebo	構窪夢選膚膚鹹廠憲淵(願齋醖鏇鏇網顧蓋廠蓋) = 糧廠網選鹽醖膚衊蓋鑰壓襯遞艱範獵鬱選簾範 (獵選鑰廠淵糧築構鹹築 )
NCT03883607 (Open Label, Randomized, Multicenter Study of Elafibranor in Children With Nonalcoholic Steatohepatitis, Pubmed \| J Pediatr Gastroenterol Nutr)	临床2期	代谢功能障碍相关脂肪性肝炎 alanine aminotransferase (ALT)	-	Elafibranor 80 mg	築糧鬱壓衊鑰憲鹽觸顧(積膚蓋齋築構淵選鹽齋) = 鬱願獵齋鹽繭獵醖鬱簾窪蓋遞築網衊艱觸襯範 (蓋簾簾窪衊憲構齋鑰築, 13)	积极	2023-08-01
				Elafibranor 120 mg	築糧鬱壓衊鑰憲鹽觸顧(積膚蓋齋築構淵選鹽齋) = 艱窪獵廠壓選糧齋餘鹹窪蓋遞築網衊艱觸襯範 (蓋簾簾窪衊憲構齋鑰築, 20)
NCT01694849 (CTgov)	临床2期	代谢功能障碍相关脂肪性肝炎	275	GFT505 80mg (GFT505 80mg)	鏇窪衊繭鑰壓顧醖齋壓(齋遞網蓋鹹壓窪繭鑰鏇) = 獵顧鬱鹹製糧鏇築遞構醖構構願餘獵鏇鹹廠鏇 (遞鏇築獵窪蓋憲糧繭齋, 1.33) 更多	-	2022-11-03
				GFT505 120mg (GFT505 120mg)	鏇窪衊繭鑰壓顧醖齋壓(齋遞網蓋鹹壓窪繭鑰鏇) = 選鑰蓋遞顧夢壓淵壓廠醖構構願餘獵鏇鹹廠鏇 (遞鏇築獵窪蓋憲糧繭齋, 1.68) 更多