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

/ SuspendedN/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2026-03-01

申办/合作机构-

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

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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172

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.

2026-06-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Elafibranor inhibits neointima formation by downregulating CDK1 expression in carotid artery injury mice model

Article

作者: Chen, Jingjie ; Wang, Xuesheng ; Jiang, Ding-Sheng ; Zhao, Fang ; Gong, Fu-Han ; Huo, Bo ; Cheng, Wenlin ; Lin, Wenxin

In-stent restenosis remains a major challenge in coronary artery disease management. The proliferation, migration, and phenotypic switching of vascular smooth muscle cells (VSMCs) are key drivers of neointimal hyperplasia and restenosis. Pharmacological agents targeting these processes may therefore offer a strategy to prevent or treat neointima formation. Here, we demonstrate that elafibranor (also known as GFT505), a dual agonist of peroxisome proliferator-activated receptor alpha (PPARα) and peroxisome proliferator-activated receptor delta (PPARδ), significantly reduced neointima formation in a mouse model of carotid artery injury. In vitro, PDGF-BB stimulation induced VSMC proliferation, migration, and a phenotypic switch towards a synthetic state-all of which were markedly suppressed by elafibranor. Cell Counting Kit-8 assays, 5-Ethynyl-2'-deoxyuridine (EdU) incorporation, and proliferation markers (phosphorylated histone H3 (Ser10) and Proliferating Cell Nuclear Antigen (PCNA)) indicated that elafibranor inhibited VSMC proliferation primarily by inducing cell cycle arrest at the G2/M phase. Transwell assays and reduced expression of matrix metallopeptidase 2 (MMP2) and matrix metallopeptidase 9 (MMP9) pointed to a significant inhibition of VSMC migration. In addition, elafibranor suppressed the transition of VSMCs from a contractile to a synthetic phenotype, as shown by changes in marker expression. Mechanistically, transcriptome sequencing with Kyoto Encyclopedia of Genes and Genomes (KEGG), Gene Ontology (GO), and Gene Set Enrichment Analysis (GSEA) analyses revealed that elafibranor modulated pathways linked to cell proliferation and cycle control. In particular, it downregulated cyclin-dependent kinase 1 (CDK1), a key regulator of the G2/M checkpoint. Overexpression of CDK1 reversed the inhibitory effects of elafibranor on VSMC proliferation, migration, and phenotypic switching. Together, these findings identify elafibranor as a potential therapeutic agent capable of suppressing neointimal hyperplasia, pointing to a new approach for preventing and treating in-stent restenosis.

2026-05-01·CPT-Pharmacometrics & Systems Pharmacology

Population Pharmacokinetics and Pharmacokinetics‐Pharmacodynamics Analyses of Elafibranor to Support Dose Selection in Primary Biliary Cholangitis

Article

作者: Brendel, Karl ; Ooi, Qing Xi ; van Beek, Stijn ; Dehez, Marion ; Bardol, Maddlie ; Zdovc, Jurij Aguiar

ABSTRACT:

Elafibranor 80 mg/day is approved for second‐line primary biliary cholangitis (PBC) treatment. We present pharmacokinetic (PK) analyses of elafibranor and its metabolite, GFT1007, and pharmacokinetic‐pharmacodynamic (PKPD) analyses describing the relationship between their exposure and responses in alkaline phosphatase (ALP) and total bilirubin (TB). PK data originated from 17 clinical trials. Separate elafibranor and GFT1007 PK models were developed using nonlinear mixed‐effects modeling. Effects of covariates on PK parameters were explored. PKPD data originated from one phase II and one phase III trial; separate ALP and TB models were developed using a sequential approach. The sum of the areas under the plasma‐concentration time curve during a dosing interval at steady state of elafibranor and GFT1007 (AUC τ,ss sum ) from the PK models was used as a driver for drug effects. A joint ALP‐TB model, considering correlations in the inter‐individual variability on selected parameters, was developed and used to perform simulations. Elafibranor and GFT1007 are described by structurally similar two‐compartmental models. Elafibranor has a longer elimination half‐life versus GFT1007 (59.7 versus 10.7 h); predicted time to steady state was 12.4 versus 2.22 days. Covariate effects on the PK of elafibranor and GFT1007 had a limited effect on the PD response of patients receiving the 80 mg/day regimen. Based on PKPD simulations, elafibranor 80 mg/day showed a clear effect and improvement in ALP and TB versus placebo. Saturation in ALP responses was observed for > 30 μmol·h/L, reached by around 60% of patients. These analyses support that elafibranor 80 mg/day is an efficacious PBC treatment.

349

项与 Elafibranor 相关的新闻（医药）

2026-06-15

·ir.genfit.com

GENFIT: June 15, 2026 Combined Shareholders Meeting Results

All resolutions recommended by the Board of Directors approved (quorum: 32.13 %) Lille (France); Cambridge, (Massachusetts, United States); Zurich (Switzerland); June 15, 2026 - GENFIT (Euronext: GNFT),, a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the results of the Combined Shareholders Meeting which took place on June 15, 2026. The quorum on first convening amounted to 32.13 % and shareholders approved all of the resolutions, with the exception of resolution n°26 which was rejected in accordance with the recommendations of the Board of Directors. The voting results, resolution by resolution, are available in the Investors & Media section of the Company’s website (Shareholders Meeting | GENFIT). ABOUT GENFIT GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for second-line treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.1 Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements with respect to GENFIT. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2025 Universal Registration Document filed on April 3, 2026 (no. D.26-0221) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in reports filed with the AMF or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACTS GENFIT | InvestorsJean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 | jean-christophe.marcoux@genfit.com GENFIT | Media Bruno ARABIAN – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.frStephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 Elafibranor is marketed and commercialized in the U.S by Ipsen under the trademark Iqirvo®. Attachment GENFIT: June 15, 2026 Combined Shareholders Meeting Results

加速审批

2026-06-14

·信狐药迅

三个国产1类新药：博瑞制药BGM0504、江苏豪森HS-10568和成都百利多特BL-B01D1提交上市申请|新受理（6.8-6.14）

本周药品注册受理数据，分门别类呈现，一目了然。(6.8-6.14）新药上市申请药品名称企业注册分类受理号 BGM0504注射液博瑞制药(苏州)有限公司 1 CXHS2600087 BGM0504注射液博瑞制药(苏州)有限公司 1 CXHS2600086 BGM0504注射液博瑞制药(苏州)有限公司 1 CXHS2600089 BGM0504注射液博瑞制药(苏州)有限公司 1 CXHS2600088 HS-10568注射液江苏豪森药业集团有限公 1 CXHS2600085 注射用BL-B01D1 成都百利多特生物药业有限责任公司 1 CXSS2600090 新药临床申请药品名称企业注册分类受理号 RN5681注射液深圳市大睿生物科技研究有限公司 1 CXHL2600705 IBI3040 信达生物制药(苏州)有限公司 1 CXHL2600710 IBI3032 信达生物科技有限公司 1 CXHL2600709 IBI3032 信达生物科技有限公司 1 CXHL2600708 IBI3032 信达生物科技有限公司 1 CXHL2600707 IBI3032 信达生物科技有限公司 1 CXHL2600706 TB-B002D注射液深圳市图微安创科技开发有限公司 1 CXHL2600694 TB-B002D注射液深圳市图微安创科技开发有限公司 1 CXHL2600693 TB-B002D注射液深圳市图微安创科技开发有限公司 1 CXHL2600697 TB-B002D注射液深圳市图微安创科技开发有限公司 1 CXHL2600696 YKYY033注射液北京悦康科创医药科技股份有限公司 1 CXHL2600704 YKYY033注射液北京悦康科创医药科技股份有限公司 1 CXHL2600702 YKYY033注射液北京悦康科创医药科技股份有限公司 1 CXHL2600703 IPG1094片南京艾美斐生物医药科技股份有限公司 1 CXHL2600685 YXC-002片上海谊众药业股份有限公司 1 CXHL2600688 YXC-002片上海谊众药业股份有限公司 1 CXHL2600687 IPG1094片南京艾美斐生物医药科技股份有限公司 1 CXHL2600686 ACT201注射液厦门特宝生物工程股份有限公司 1 CXHL2600690 HRS-1597片山东盛迪医药有限公司 1 CXHL2600692 HRS-1597片山东盛迪医药有限公司 1 CXHL2600691 铜[64Cu]-RAX301注射液上海君康立泰生物医药科技有限公司 1 CXHL2600689 YL-13027片上海璎黎药业有限公司 1 CXHL2600678 YL-13027片上海璎黎药业有限公司 1 CXHL2600677 HSK47388片(I) 海思科医药集团股份有限公司 1 CXHL2600680 HSK47388片(I) 海思科医药集团股份有限公司 1 CXHL2600679 CA-301注射液原研港脑科学技术(上海)有限公司 1 CXHL2600682 WRC2301 济南维瑞医药科技开发有限公司 2.2 CXHL2600684 WRC2301 济南维瑞医药科技开发有限公司 2.2 CXHL2600683 甲硝唑滴眼液中山万汉制药有限公司 2.2;2.4 CXHL2600698 WTITD003片广东万泰元科创药业有限公司 2.2;2.4 CXHL2600701 WTITD003片广东万泰元科创药业有限公司 2.2;2.4 CXHL2600700 甲硝唑滴眼液中山万汉制药有限公司 2.2;2.4 CXHL2600699 注射用泮托拉唑钠广东万泰元科创药业有限公司 2.4 CXHL2600695 莫米司特片赣州和美药业股份有限公司 2.4 CXHL2600681 皮内注射用重组卡介苗成都安永鼎业生物技术有限公司 2.2 CXSL2600636 GC012F注射液亘喜生物科技(上海)有限公司 1 CXSL2600633 注射用Efimosfermin alfa 葛兰素史克(中国)投资有限公司 1 CXSL2600632 重组抗IL-4Rα人源化单抗注射液三生国健药业(上海)股份有限公司 1 CXSL2600635 AZD5863 阿斯利康全球研发(中国)有限公司 1 CXSL2600634 HY001N细胞注射液合源生物科技股份有限公司 1 CXSL2600628 注射用AK157D1 中山康方生物医药有限公司 1 CXSL2600629 HS-IT101注射液青岛中赛伯曼生物科技有限公司 1 CXSL2600631 SCTB10注射液神州细胞工程有限公司 1 CXSL2600630 SK10胶囊广州知易生物科技股份有限公司 1 CXSL2600624 靶向间皮素嵌合抗原受体NK细胞注射液国健亦诺生物科技(北京)有限公司 1 CXSL2600620 DY1133滴眼剂厦门红观生物科技有限公司 1 CXSL2600618 重组抗CD19m-CD3抗体注射液天劢源和生物医药(长春)有限公司 1 CXSL2600625 SCTA02A注射液神州细胞工程有限公司 1 CXSL2600627 注射用TQB6426 上海正大天晴医药科技开发有限公司 1 CXSL2600626 注射用HBM7004 和铂医药(上海)有限责任公司 1 CXSL2600623 注射用QLS2319 齐鲁制药有限公司 1 CXSL2600619 ZMPB-NK006注射液北京美欧赛奥金生物科技有限公司 1 CXSL2600614 IBR822细胞注射液英百瑞(杭州)生物医药股份有限公司 1 CXSL2600613 IBR822细胞注射液英百瑞(杭州)生物医药股份有限公司 1 CXSL2600612 RG002注射液仁景(苏州)生物科技有限公司 1 CXSL2600611 Pumitamig注射液百欧恩泰(上海)医药有限公司 1 CXSL2600617 注射用RT023 上海偌妥生物科技有限公司 1 CXSL2600616 西妥昔单抗β注射液泰州迈博太科药业有限公司 2.2 CXSL2600615 仿制药申请药品名称企业注册分类受理号米诺地尔搽剂湖北康正药业有限公司 3 CYHS2601401 米诺地尔搽剂湖北康正药业有限公司 3 CYHS2601400 环磷酰胺注射液上海创诺制药有限公司 3 CYHS2601403 注射用甲磺酸萘莫司他重庆华邦制药有限公司 3 CYHS2601406 注射用甲磺酸萘莫司他重庆华邦制药有限公司 3 CYHS2601405 盐酸西替利嗪注射液山东新时代药业有限公司 3 CYHS2601399 布美他尼注射液丹东医创药业有限责任公司 3 CYHS2601384 布美他尼注射液丹东医创药业有限责任公司 3 CYHS2601382 磷酸奥司他韦颗粒重庆万霖生物医药科技有限公司 3 CYHS2601380 盐酸溴己新口服溶液江苏神华药业有限公司 3 CYHS2601379 盐酸氯普鲁卡因注射液江苏万高药业股份有限公司 3 CYHS2601393 盐酸氯普鲁卡因注射液江苏万高药业股份有限公司 3 CYHS2601392 盐酸氨溴索滴剂安徽康融药业有限公司 3 CYHS2601389 注射用盐酸兰地洛尔哈尔滨三联药业股份有限公司 3 CYHS2601362 吡非尼酮片成都倍特药业股份有限公司 3 CYHS2601361 氨基酸(15)腹膜透析液广东科泓药业有限公司 3 CYHS2601360 氨基酸(15)腹膜透析液广东科泓药业有限公司 3 CYHS2601359 注射用甲磺酸萘莫司他南京正大天晴制药有限公司 3 CYHS2601358 注射用甲磺酸萘莫司他南京正大天晴制药有限公司 3 CYHS2601357 盐酸利多卡因眼用凝胶沈阳兴齐眼药股份有限公司 3 CYHS2601374 曲安奈德益康唑乳膏福元药业有限公司 3 CYHS2601373 曲安奈德益康唑乳膏福元药业有限公司 3 CYHS2601372 比拉斯汀口服溶液广州大光制药有限公司 3 CYHS2601344 布洛芬去氧肾上腺素片康芝药业股份有限公司 3 CYHS2601350 洛索洛芬钠口服溶液江西众泽源医药科技有限公司 3 CYHS2601325 马来酸噻吗洛尔滴眼液广东南国药业有限公司 3 CYHS2601324 普瑞巴林缓释片北京泰德制药股份有限公司 3 CYHS2601329 普瑞巴林缓释片北京泰德制药股份有限公司 3 CYHS2601328 西甲硅油咀嚼片江西施美药业股份有限公司 3 CYHS2601335 普瑞巴林口崩片山东创新药物研发有限公司 3 CYHS2601334 普瑞巴林口崩片山东创新药物研发有限公司 3 CYHS2601333 普瑞巴林口崩片山东创新药物研发有限公司 3 CYHS2601332 美洛昔康注射液(III) 健康元药业集团股份有限公司 3 CYHS2601331 注射用甲磺酸萘莫司他湖南埃威格林医药科技有限公司 3 CYHS2601327 盐酸多塞平片沈阳华泰药物研究有限公司 3 CYHS2601336 苯磺酸美洛加巴林片山东鲁抗医药股份有限公司 4 CYHS2601398 苯磺酸美洛加巴林片山东鲁抗医药股份有限公司 4 CYHS2601397 磷酸特地唑胺片浙江东亚药业股份有限公司 4 CYHS2601396 依折麦布片南京海鲸药业股份有限公司 4 CYHS2601395 磷霉素氨丁三醇颗粒安徽新世纪药业有限公司 4 CYHS2601402 乌帕替尼缓释片濮阳市汇元药业有限公司 4 CYHS2601404 氧泸州市纳溪区金鑫气体化工有限公司 4 CYHS2601376 糠酸莫米松乳膏苏州高迈药业有限公司 4 CYHS2601375 阿托伐他汀钙片江苏万高药业股份有限公司 4 CYHS2601378 阿托伐他汀钙片江苏万高药业股份有限公司 4 CYHS2601377 苯磺酸美洛加巴林片天方药业有限公司 4 CYHS2601386 苯磺酸美洛加巴林片天方药业有限公司 4 CYHS2601385 苯磺酸美洛加巴林片天方药业有限公司 4 CYHS2601383 盐酸莫西沙星氯化钠注射液湖北广济药业股份有限公司 4 CYHS2601381 替米沙坦氨氯地平片海南赛立克药业有限公司 4 CYHS2601394 瑞维那新吸入溶液东吴制药(山东)有限公司 4 CYHS2601391 单硝酸异山梨酯缓释胶囊(IV) 鲁南贝特制药有限公司 4 CYHS2601390 帕拉米韦氯化钠注射液信合援生制药股份有限公司 4 CYHS2601388 帕拉米韦氯化钠注射液信合援生制药股份有限公司 4 CYHS2601387 蒙脱石混悬液重庆国泰康宁制药有限责任公司 4 CYHS2601363 布瑞哌唑片浙江华义制药有限公司 4 CYHS2601356 布瑞哌唑片浙江华义制药有限公司 4 CYHS2601355 沙库巴曲缬沙坦钠片瑞阳制药股份有限公司 4 CYHS2601354 沙库巴曲缬沙坦钠片瑞阳制药股份有限公司 4 CYHS2601353 西诺氨酯片江苏恩华药业股份有限公司 4 CYHS2601366 西诺氨酯片江苏恩华药业股份有限公司 4 CYHS2601365 西诺氨酯片江苏恩华药业股份有限公司 4 CYHS2601364 达格列净片迪沙药业集团有限公司 4 CYHS2601369 精氨酸布洛芬片湖南华纳大药厂股份有限公司 4 CYHS2601368 克立硼罗软膏哈药集团生物工程有限公司 4 CYHS2601367 环吡酮搽剂江苏知原药业股份有限公司 4 CYHS2601371 缬沙坦氢氯噻嗪片浙江金立源药业有限公司 4 CYHS2601370 多替诺雷片辽宁鑫善源药业有限公司 4 CYHS2601347 多替诺雷片辽宁鑫善源药业有限公司 4 CYHS2601346 多替诺雷片辽宁鑫善源药业有限公司 4 CYHS2601345 吸入用丙酸倍氯米松混悬液河北汇德旭盛医药科技有限公司 4 CYHS2601343 吗啉硝唑氯化钠注射液中国大冢制药有限公司 4 CYHS2601351 盐酸曲唑酮缓释片兆科药业(广州)有限公司 4 CYHS2601349 盐酸曲唑酮缓释片兆科药业(广州)有限公司 4 CYHS2601348 阿达帕林过氧苯甲酰凝胶四川科瑞德制药股份有限公司 4 CYHS2601352 苯磺酸美洛加巴林片江西山香药业有限公司 4 CYHS2601326 罗替高汀贴片湖南派格兰药业有限公司 4 CYHS2601323 罗替高汀贴片湖南派格兰药业有限公司 4 CYHS2601322 罗替高汀贴片湖南派格兰药业有限公司 4 CYHS2601321 盐酸奥洛他定滴眼液南京海纳制药有限公司 4 CYHS2601339 利丙双卡因乳膏重庆康刻尔制药股份有限公司 4 CYHS2601330 多替诺雷片杭州中美华东制药有限公司 4 CYHS2601340 雌二醇片/雌二醇地屈孕酮片复合包装四川科伦药业股份有限公司 4 CYHS2601338 雌二醇片/雌二醇地屈孕酮片复合包装四川科伦药业股份有限公司 4 CYHS2601337 蛋白琥珀酸铁口服溶液湖南千金协力药业有限公司 4 CYHS2601341 氢溴酸替格列汀片远大医药(天津)有限公司 4 CYHS2601342 德谷门冬双胰岛素注射液杭州中美华东制药有限公司 3.3 CXSS2600092 德谷门冬双胰岛素注射液杭州中美华东制药有限公司 3.3 CXSS2600091 盐酸右哌甲酯片河南中帅药业有限公司 3 CYHL2600070 盐酸哌甲酯缓释咀嚼片北京华素制药股份有限公司 4 CYHL2600071 特立帕肽注射液昆山新蕴达生物科技有限公司 3.3 CXSL2600621 西妥昔单抗注射液上海宏成药业有限公司 3.3 CXSL2600622 进口申请药品名称企业注册分类受理号阿帕他胺片 Janssen-Cilag International NV 2.4 JXHS2600061 注射用罗特西普 Celgene Corporation 2.2 JXSS2600051 注射用罗特西普 Celgene Corporation 2.2 JXSS2600050 BMS-986510胶囊 Bristol-Myers Squibb Company 2.4 JXHL2600218 BMS-986510胶囊 Bristol-Myers Squibb Company 2.4 JXHL2600217 BMS-986510胶囊 Bristol-Myers Squibb Company 2.4 JXHL2600216 Elafibranor片 Ipsen Bioscience, Inc. 2.4 JXHL2600215 奥氟格列隆钙片 Eli Lilly and Company 2.4 JXHL2600212 奥氟格列隆钙片 Eli Lilly and Company 2.4 JXHL2600211 奥氟格列隆钙片 Eli Lilly and Company 2.4 JXHL2600210 奥氟格列隆钙片 Eli Lilly and Company 2.4 JXHL2600209 奥氟格列隆钙片 Eli Lilly and Company 2.4 JXHL2600208 奥氟格列隆钙片 Eli Lilly and Company 2.4 JXHL2600207 BYL719 Novartis Pharma AG 2.4 JXHL2600214 BYL719 Novartis Pharma AG 2.4 JXHL2600213 AZD2936 AstraZeneca AB 1 JXSL2600141 GIA632注射液 Novartis Pharma AG 1 JXSL2600140 中药相关申请药品名称企业注册分类受理号芪地通便颗粒山东汉方制药股份有限公司 1.1 CXZL2600054 西帕依固龈液新奇康药业股份有限公司 2.3 CXZL2600055 苓桂术甘汤颗粒长沙新林制药有限公司 3.1 CXZS2600031 抗病毒口服液华润三九(雅安)药业有限公司 4 CYZS2600002 注：绿色字体部分为潜在首仿品种；咸达数据2026年5月每月药讯已出！关注“咸达数据”，微信关键词回复 ” 年+月，如202605” 获得最新药迅！不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

引进/卖出申请上市

2026-06-11

·药研前瞻

一粒药的二十二年：Seladelpar的沉浮与重生

2000年初的加州湾区，基因组学和代谢疾病研究正如火如荼。Metabolex公司的一间实验室里，化学家们合成了一批又一批小分子化合物，它们被注入高脂小鼠体内，研究人员盯着血脂指标，希望找到一柄降脂的利剑。谁也不会想到，这批化合物中的一个，在二十多年后会成为原发性胆汁性胆管炎（PBC）患者手中的救命药——它的名字叫Seladelpar。这是一个关于坚持、转向与救赎的故事。一款药，两家公司，三度濒死，最终在被代谢疾病领域“除名”的边缘，凭借一个几乎毫不相干的自身免疫性肝病，站稳了脚跟。PPARδ：一把被低估的钥匙要理解Seladelpar，得先认识PPARδ。过氧化物酶体增殖物激活受体，听起来像一串密码，实际上它们确实是细胞核内的信号开关，有三种亚型：α、γ、δ。α管血脂，激活贝特类药物；γ管血糖，噻唑烷二酮类降糖药就是它的钥匙。唯独δ像个隐士，分布广泛，却迟迟找不到专属的药物。激活PPARδ能加速脂肪酸燃烧、调节能量代谢，理论上对肥胖、血脂异常、糖尿病都有好处。九十年代末到本世纪初，几乎所有大药企都往这个靶点砸钱。 Metabolex也是其中一员。这家成立于1992年的生物技术公司，一直扎根于代谢病，早期产品MBX-102是一种PPARγ调节剂，梦想着改善胰岛素抵抗，但安全性亮起了红灯，最终搁浅。公司把希望寄托在下一代化合物上——针对PPARδ，开发一种高选择性的激动剂。这就是MBX-8025，Seladelpar的前身。起初的想法很直白：做成降脂药。2008年，MBX-8025进入临床一期，次年开启名为SPIRE的二期试验，招募混合型高脂血症患者。试验显示，它能降低甘油三酯、升高高密度脂蛋白，数据有统计学意义，却称不上惊艳。问题在于，降脂领域早已是一片红海，他汀类地位稳固，贝特类、烟酸乃至后来的PCSK9抑制剂你争我夺，一个微弱的优势很难说服支付方和处方医生。华尔街和合作方强生相继撤出，Metabolex几乎走到了尽头。 2013年，Metabolex更名CymaBay，管理层换血，砍掉不相关的管线，把剩下的子弹全压在了MBX-8025身上。新名字——Seladelpar，取自希腊神话里的月亮女神塞勒涅（Selene）和“PAR”的缩写，希望它能像月光一样照亮前路。但当时的CymaBay市值微薄，没人看好这颗遗珠。移花接木：从降脂到利胆转机来自科学家对PPARδ功能的重新审视。人们发现，PPARδ在肝脏中高度表达，参与胆汁酸合成的关键酶CYP7A1的调控。激活PPARδ，能抑制胆汁酸合成，改善胆汁淤积。而胆汁淤积，正是原发性胆汁性胆管炎的核心病理。PBC是一种自身免疫性肝病，免疫系统攻击肝内小胆管，胆汁排不出去，淤积在肝脏里，像个垃圾场一样引发炎症、纤维化，最终走向肝硬化。患者血液里的碱性磷酸酶（ALP）和γ-谷氨酰转移酶（GGT）飙升，皮肤奇痒难忍，骨头酸痛，疲劳不堪。当时PBC的治疗手段少得可怜。一线药熊去氧胆酸（UDCA）能改善胆汁流，但近四成患者应答不佳；二线药只有奥贝胆酸（OCA），一种FXR激动剂，虽然降ALP有效，却会加剧瘙痒，还背着一个肝毒性黑框警告。对于这些应答不佳又深受瘙痒折磨的患者，临床空白巨大。 CymaBay的团队盯着Seladelpar的早期机制研究，隐约嗅到了机会。既然PPARδ能抑制胆汁酸合成，又有抗炎和抗纤维化的潜力，为什么不去试试PBC？2015年，公司大胆地启动了一项开放标签的概念验证二期试验，入组对UDCA应答不佳的PBC患者，给Seladelpar单药，看的是ALP的变化。 2016年秋天，结果揭晓。Seladelpar展现出惊人的降ALP能力，50毫克和200毫克剂量组在12周内将ALP拉低至接近正常，瘙痒评分也显著改善。更关键的是，它没有OCA那样加剧瘙痒的尴尬，安全性相当干净。也就是说，它不仅可能控制疾病，还可能缓解患者最难熬的症状。消息一出，CymaBay的股价从谷底反弹，公司终于喘过气来，迅速启动了关键三期ENHANCE研究，目标是让Seladelpar成为PBC二线治疗的新标准。风暴突至：NASH暗礁如果故事这么一帆风顺，Seladelpar的研发史就太无聊了。2017年以后，CymaBay带着新生的信心，同时推进PBC的ENHANCE三期和NASH（非酒精性脂肪性肝炎）的二期试验。NASH是另一个代谢病领域的大赌场，PPARδ激活能改善脂代谢和炎症，看起来顺理成章。CymaBay想一箭双雕。 2019年6月，晴天霹雳。公司在NASH二期的肝活检中，发现了一些“非典型”的组织学变化：部分患者肝组织里出现了界面性肝炎——一种通常在自身免疫性肝炎中才看到的炎症模式。公司不得不暂停NASH试验入组。几个月后，美国FDA在2019年11月正式对Seladelpar所有在研适应症下达临床暂停令，包括正在入组的PBC关键三期ENHANCE。原因在于，FDA无法排除药物诱导自身免疫性肝损伤的可能性。这是一个毁灭性的决定。临床暂停意味着新患者不能入组，所有已入组患者必须停药。ENHANCE试验戛然而止，CymaBay的股价从近7美元暴跌至不到2美元。原本清晰的前路瞬间变作一片漆黑。外界纷纷猜测，这个药是不是要凉了。 CymaBay进入了至暗时刻。CEO Sujal Shah在内部会议上对员工说：“我们需要用数据和科学，而不是辩护，来说服监管机构。”公司忍痛裁员维持现金流，同时把所有资源倾注在一件事情上——弄清楚那些肝脏病理变化到底是什么。他们召集了全球顶尖的肝脏病理学家，组成独立专家组，对NASH试验中所有的肝活检切片进行盲法重新阅片。分析结果慢慢浮出水面：所谓“非典型”变化，不仅出现在Seladelpar组，安慰剂组也有一定比例。很多被最初标记为“界面性肝炎”的切片，在严谨的评分标准下，更符合NASH本身的活动性炎症特征。NASH这个疾病本身就伴随着门管区炎症，过去被忽视了。药物相关的肝损伤并不成立。同时，回顾所有PBC试验的数据，没有任何一例符合药物诱导肝损伤的生化标准。 2020年3月，CymaBay将整套分析报告递交FDA。经过四个月的审慎审查，FDA在7月解除了临床暂停。笼罩在Seladelpar上空的乌云散开，阳光重新洒下，但CymaBay已经元气大伤：ENHANCE试验因提前中止而样本量受损，单独依靠它申请上市，统计学说服力不足。背水一战：RESPONSE的完美答卷 CymaBay没有退路。2021年，公司与FDA协商后，重新设计了一个全新的三期试验——RESPONSE。这是一项完全随机、双盲、安慰剂对照的注册研究，入组对UDCA应答不佳或无法耐受的PBC患者，按照2:1接受Seladelpar 10毫克或安慰剂治疗。主要终点被定为“复合生化应答”：12个月时，ALP降至1.67倍正常上限以下、且较基线下降至少15%，同时总胆红素正常。这个复合终点比单纯的ALP下降更为严苛，因为它直接关联了无移植生存率——也就是说，它能预示患者是否活得更久、不用换肝。 RESPONSE在近20个国家铺开，顶着新冠疫情的压力入组了近200名患者。2023年9月7日，答案揭晓：61.7%的患者达到主要终点，而安慰剂组只有20%。组间差异超过41个百分点，p值小到可以忽略不计。更重要的是，关键次要终点瘙痒——通过患者每日记录的NRS评分衡量——在Seladelpar组实现了有临床意义的显著下降。这可是之前任何二线药物都未能充分解决的问题。同时，安全性数据干净，没有出现与药物相关的严重不良反应，没有黑框警告级别的隐患。在医学会议上公布这些数据时，会场里响起掌声。对于PBC领域而言，这几乎是久违的胜利。UDCA问世于上世纪九十年代，OCA虽然有效却因瘙痒和肝毒性让很多医生和患者纠结不已。而Seladelpar就像一个“多边形战士”：降ALP、降胆红素、缓解瘙痒、耐受性良好。基于这份答卷，CymaBay在2023年12月向FDA提交了新药上市申请，并获得了优先审评资格。吉利德的43亿赌注数据读出后不久，嗅觉敏锐的买家就敲响了CymaBay的门。2024年2月12日，吉利德科学宣布以每股32.5美元、总交易价值约43亿美元的价格收购CymaBay。这笔交易的核心标的，就是Seladelpar。吉利德是肝病领域的巨无霸，在乙肝、丙肝上缔造过治愈神话，但丙肝市场萎缩后，它亟需下一个肝病增长点。PBC虽然是罕见病，但在全球有相当稳定的患者存量，且二线治疗远未饱和。Seladelpar凭借其疗效和瘙痒改善优势，完全有潜力成为基石疗法。43亿的收购价，对于一款尚未获批、但已递交NDA的罕见病药物来说，算是一笔豪赌。吉利德的资源注入，也加速了Seladelpar的上市进程和商业化准备。2024年8月14日，FDA正式加速批准Seladelpar上市，商品名Livdelzi，用于联合UDCA治疗应答不佳的成人PBC，或单药用于不能耐受UDCA的患者。这是继Iqirvo（Elafibranor）获批后，半年内第二个获批的PBC新药。PBC患者终于等来了真正的“选择困难症”时刻：两款新一代药物，一个PPARδ选择激动剂，一个PPARα/δ双重激动剂，各有千秋。但Seladelpar在瘙痒改善上的差异化数据，让它在临床讨论中占据了特殊的位置。二十二年沉浮的注脚从Metabolex的降脂梦，到CymaBay的胆管守护者，再到吉利德的肝病版图利器，一粒Seladelpar浓缩了现代药物研发的残酷与魅力。它之所以能活下来，靠的不是初始设计，而是科学上的重新发现。PPARδ从代谢综合征的“万金油”靶点，变成胆汁酸稳态的关键调节器，这一认知迁移，是基础研究馈赠的意外礼物。它之所以没死在临床暂停的刀下，靠的是病理切片的客观复读，以及公司管理层孤注一掷的透明沟通——不掩盖，不狡辩，把每一张切片拿出来让全世界最好的专家看。这给行业留下了一笔危机处理的正面教材。回看Seladelpar的临床数据，它并没有创造什么颠覆性的生物学新机制，却把每一个临床需求的痛点都照顾到了：生化应答够硬，瘙痒改善够直接，安全性够干净。这种“均衡”往往比单项冠军更能赢得临床信任。对于患者而言，从每天抓挠到皮肤出血、骨痛难忍的困境里解脱出来，哪怕只是瘙痒NRS评分下降两分，也是生活质量质的飞跃。在RESPONSE试验的受试者自述中，有患者说：“我不再需要在夜里戴着手套睡觉，怕把自己抓伤。”这种回馈，任何p值和商业估值都无法衡量。如今，Seladelpar正在全球多个市场申请上市，长期结局研究也在推进，以确证它延缓肝硬化、推迟肝移植的终极价值。同时，吉利德也在探索它在其他胆汁淤积性肝病中的潜力。站在2026年的今天回顾，Seladelpar的二十二年，像一场生物学、医学与运气的三重奏。它提醒我们：药物的命运，从来不在化合物的第一个瓶子里，而在科学家不断切换的视角里，在数据面前敢于认错又敢于坚持的勇气里，在那些等不到好药的患者无声的等待里。这或许就是新药研发最动人的部分——它不是一条直线，而是一盏在迷雾中忽明忽暗的灯，需要无数只手接力，护住它不灭。

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

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
纤维化	临床3期	美国	Genfit SA	2016-03-01
纤维化	临床3期	阿根廷	Genfit SA	2016-03-01
纤维化	临床3期	澳大利亚	Genfit SA	2016-03-01
纤维化	临床3期	比利时	Genfit SA	2016-03-01
纤维化	临床3期	加拿大	Genfit SA	2016-03-01
纤维化	临床3期	智利	Genfit SA	2016-03-01
纤维化	临床3期	哥伦比亚	Genfit SA	2016-03-01
纤维化	临床3期	捷克	Genfit SA	2016-03-01
纤维化	临床3期	丹麦	Genfit SA	2016-03-01

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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


NCT04526665 (ELATIVE, Pubmed \| Liver Int)	临床3期	原发性胆汁性胆管炎二线	468	Elafibranor	艱醖醖簾構憲簾夢遞衊(築網鑰獵廠憲願艱糧範) = 壓鹹積窪鹽鏇範範鹹膚壓艱構蓋鬱餘淵醖廠衊 (糧遞鹽齋膚鬱艱憲遞鏇 ) 更多	积极	2026-05-01
				Placebo	鹹鹽製顧網齋憲衊遞餘(觸糧艱築艱繭構鹹鹹鹹) = 壓壓鏇糧夢淵壓顧觸鬱鑰膚遞蓋鹽襯鑰蓋鏇網 (簾鑰艱構範獵遞鏇觸願 )
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	遞餘齋鹹築觸鬱構艱遞(餘糧鏇憲鑰廠衊網醖餘) = 網網構醖衊壓顧鬱範窪窪齋顧廠餘襯衊鑰衊窪 (齋鹹膚觸艱積遞鹽衊範 ) 更多	积极	2025-05-01
				Elafibranor 120 mg	遞餘齋鹹築觸鬱構艱遞(餘糧鏇憲鑰廠衊網醖餘) = 鏇襯膚齋遞憲鬱顧鬱築窪齋顧廠餘襯衊鑰衊窪 (齋鹹膚觸艱積遞鹽衊範 ) 更多
NCT05627362 (ELMWOOD, NEWS) 人工标引	临床2期	原发性硬化性胆管炎	68	elafibranor	窪壓願窪醖鬱窪壓鬱襯(選獵鑰鬱製鹽獵構鏇夢) = Data from ELMWOOD demonstrated a positive safety and tolerability profile. 鹽齋觸範觸壓範艱繭願 (鹹鏇繭選壓鹹夢繭築觸 ) 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	齋積糧製艱繭顧夢製觸 = 廠繭獵鏇夢遞鏇艱艱鬱簾繭範襯簾窪構繭衊夢 (夢鏇淵顧顧觸鏇夢艱壓, 簾觸夢網淵選範醖繭構 ~ 鹹繭繭遞鹽餘艱衊艱憲) 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	鹹觸願繭範襯鬱襯鹹廠(觸範選選觸齋廠憲醖膚) = 廠膚積糧醖夢衊鏇遞艱遞網遞網艱積蓋糧餘鏇 (網網鏇蓋範簾鬱顧積壓 ) 更多	积极	2024-06-10
				Placebo	鹹觸願繭範襯鬱襯鹹廠(觸範選選觸齋廠憲醖膚) = 構襯選餘醖衊襯繭廠獵遞網遞網艱積蓋糧餘鏇 (網網鏇蓋範簾鬱顧積壓 ) 更多
NCT04526665 (ELATIVE, EASL2024) 人工标引	临床3期	原发性胆汁性胆管炎	161	Elafibranor	齋積餘遞鹹簾齋鏇蓋淵(醖夢構遞製鏇築膚鏇遞) = 網鑰鬱鹽網鹽窪鹽壓築淵膚蓋簾遞壓襯願繭觸 (廠鏇齋窪鹽遞醖糧遞憲 ) 更多	积极	2024-06-01
				Placebo	獵窪選獵壓獵築鏇遞憲(選衊夢築觸齋鏇鏇窪觸) = 蓋齋廠遞鬱淵顧鬱淵糧鏇淵願範襯艱淵觸憲餘 (鹽築鹹製淵淵鏇壓繭膚 )
NCT04526665 (ELATIVE, Pubmed) 人工标引	临床3期	原发性胆汁性胆管炎	161	Elafibranor 80 mg	築顧醖鬱構齋壓鹽範糧(積蓋遞壓鹽艱鹽築選觸) = 簾夢壓壓餘構憲夢構醖獵齋顧繭餘積網願醖艱 (鹽願鹹齋顧顧餘築鹽顧 ) 更多	积极	2024-02-29
				Placebo	築顧醖鬱構齋壓鹽範糧(積蓋遞壓鹽艱鹽築選觸) = 鑰選願鏇廠鹽鑰顧淵壓獵齋顧繭餘積網願醖艱 (鹽願鹹齋顧顧餘築鹽顧 ) 更多
NEWS 人工标引	临床3期	原发性胆汁性胆管炎	161	elafibranor	膚糧齋鏇簾衊鹹獵鹽醖(膚遞窪積膚蓋窪網繭淵): 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	選鑰選憲壓選糧鏇獵醖(鏇艱觸鏇衊窪顧鬱遞憲) = 願蓋遞糧鑰糧齋繭齋壓餘願製積製遞積顧夢簾 (繭淵淵顧膚醖積築鑰構 )	积极	2023-09-20
				placebo	選鑰選憲壓選糧鏇獵醖(鏇艱觸鏇衊窪顧鬱遞憲) = 糧製壓淵艱齋簾遞齋壓餘願製積製遞積顧夢簾 (繭淵淵顧膚醖積築鑰構 )
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	齋壓網獵壓餘窪鹹遞選(衊膚獵餘鑰鏇鹽鹽築製) = 襯獵製鬱壓顧簾襯願鏇觸淵膚醖積構遞廠鹹繭 (顧獵構廠廠構網觸繭製, 13)	积极	2023-08-01
				Elafibranor 120 mg	齋壓網獵壓餘窪鹹遞選(衊膚獵餘鑰鏇鹽鹽築製) = 積襯遞網壓積構範顧蓋觸淵膚醖積構遞廠鹹繭 (顧獵構廠廠構網觸繭製, 20)