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<meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]">
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yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK605979_"><span class="title" itemprop="name">Elafibranor</span></h1><p class="fm-aai"><a href="#_NBK605979_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Elafibranor.OVERVIEW"><h2 id="_Elafibranor_OVERVIEW_">OVERVIEW</h2><div id="Elafibranor.Introduction"><h3>Introduction</h3><p>Elafibranor is an orally available peroxisome proliferator-activated receptor agonist that is used in combination with ursodeoxycholic acid to treat primary biliary cholangitis. Elafibranor therapy is associated with rare instances of worsening of liver enzymes during therapy but has not been convincingly linked to episodes of clinically apparent liver injury with jaundice.</p></div><div id="Elafibranor.Background"><h3>Background</h3><p>Elafibranor (el’ a fib’ ran or) is an agonist of the peroxisome proliferator-activated receptors (PPAR) alpha (α), delta (δ), and gamma (γ), intracellular receptors with major effects on bile acid synthesis and transport as well as lipid metabolism and glucose homeostasis. Studies of other PPAR agonists such as pioglitazone and fenofibrate have suggested at least partial improvement in disease activity with their use in several liver diseases. Furthermore, the PPARα agonist bezafibrate has been shown to improve liver tests and histology in patients with primary biliary cholangitis (PBC, previously known as primary biliary cirrhosis) and is approved for use in Europe and Japan. Elafibranor has been shown to improve serum enzymes in several diseases including nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis. In a large, placebo controlled trial in PBC, elafibranor therapy was associated with significant improvements in serum alkaline phosphatase levels in 51% of patients compared to only 4% of placebo recipients. Treatment did not improve symptoms, and liver biopsies were not done for assessment of histological changes. Based upon its effects on serum aminotransferase and alkaline phosphatase levels, elafibranor was granted accelerated approval in 2024 for treatment of adults with PBC who have an inadequate response to or intolerance of ursodeoxycholic acid (ursodiol). It is typically given in combination with ursodiol but can be given as monotherapy in patients who are intolerant to ursodiol. Elafibranor has not been shown to prolong survival or prevent progression to cirrhosis in patients with PBC, and its continued approval is contingent on further demonstration of its clinical benefit. Elafibranor is available as tablets of 80 mg under the brand name Iqirvo. The recommended dose is 80 mg once daily. Elafibranor is not recommended for patients with advanced or decompensated cirrhosis, or complete biliary obstruction. Common adverse events include weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, gastroesophageal reflux, dry mouth, weight loss, and rash. Uncommon but potentially severe adverse events include myopathy and rhabdomyolysis, bone fractures, hypersensitivity reactions, and embryo-fetal toxicity. The risk of myalgia and rhabdomyolysis may be increased by concurrent therapy with statins, and assessment for muscle symptoms and serum creatine phosphokinase (CPK) levels is recommended before and during therapy. Elafibranor may cause fetal harm if taken during pregnancy. Women of child-bearing potential should be tested for pregnancy before starting elafibranor and practice an effective means of birth control during therapy.</p></div><div id="Elafibranor.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In preregistration clinical trials, elafibranor was found to decrease both serum aminotransferase and alkaline phosphatase elevations in a high proportion of patients with PBC. In preliminary dose-finding studies in healthy volunteers, elevations of ALT and AST levels above 5 times the upper limit of normal (ULN) were found to be dose related and occurred in one-third of subjects exposed to doses above 120 mg daily. In contrast, in clinical trials of elafibranor in doses of 80 mg daily in patients with NASH and PBC, ALT elevations above 5 times ULN occurred in only 1% to 2% of patients, typically arising within the first few months of therapy and resolving spontaneously without drug interruption and without jaundice or symptoms. Careful assessment of cases with ALT elevations concluded that 3 were possibly due to drug induced injury, 2 among 138 patients with PBC and 1 among 1433 patients with NASH. Among patients with myalgia and CPK elevations during elafibranor therapy, one patient with preexisting cirrhosis who was also taking a statin, developed jaundice [5.5 mg/dL] with elevations in ALT [300 U/L] and AST [828 U/L] concurrent with rhabdomyolysis [CPK 12,647 U/L] and subsequently suffered hepatic decompensation. The incidence of gallstones and cholecystitis also may be increased with elafibranor therapy. Rare instances of drug induced liver injury are known to occur with other PPARα (fenofibrate, bezafibrate) and PPARγ (pioglitazone, rosiglitazone) agonists.</p><p>Likelihood score: E* (unproven but suspected rare cause of clinically apparent liver injury).</p></div><div id="Elafibranor.Mechanism_of_Liver_Injury"><h3>Mechanism of Liver Injury</h3><p>The mechanism by which elafibranor might cause liver injury is unclear, but clinically apparent liver injury from other fibrates is likely immune mediated. Elafibranor is metabolized in the liver by multiple CYP isoenzymes and is susceptible to drug-drug interactions.</p></div><div id="Elafibranor.Outcome_and_Management"><h3>Outcome and Management</h3><p>The product label for elafibranor has a warning about drug induced liver injury and recommends assessing symptoms, signs, and laboratory features of liver disease before starting therapy and monitoring thereafter, with interruption if liver tests worsen or signs and symptoms of acute liver injury arise. If liver tests improve upon stopping but recur with restarting elafibranor, therapy should be permanently discontinued. There is little or no information on cross sensitivity to liver injury or adverse events between elafibranor and other therapies for PBC such as ursodiol, obeticholic acid, and other fibrates.</p><p>Drug Class: Liver Disease Agents; <a href="/books/n/livertox/ObeticholicAcid/?report=reader">Obeticholic Acid</a>, <a href="/books/n/livertox/Ursodiol/?report=reader">Ursodiol</a></p><p>Other PPAR Agonists: Bezafibrate, <a href="/books/n/livertox/Fenofibrate/?report=reader">Fenofibrate</a>, <a href="/books/n/livertox/Pioglitazone/?report=reader">Pioglitazone</a>, <a href="/books/n/livertox/Rosiglitazone/?report=reader">Rosiglitazone</a></p></div></div><div id="Elafibranor.PRODUCT_INFORMATION"><h2 id="_Elafibranor_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Elafibranor – Iqirvo®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Liver Disease Agents</p><p>
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<a href="http://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Elafibranor" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div><div id="Elafibranor.CHEMICAL_FORMULAS_AND_STRUCT"><h2 id="_Elafibranor_CHEMICAL_FORMULAS_AND_STRUCT_">CHEMICAL FORMULAS AND STRUCTURES</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figElafibranorTc"><a href="/books/NBK605979/table/Elafibranor.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img" rid-ob="figobElafibranorTc"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="Elafibranor.Tc"><a href="/books/NBK605979/table/Elafibranor.Tc/?report=objectonly" target="object" rid-ob="figobElafibranorTc">Table</a></h4></div></div></div><div id="Elafibranor.ANNOTATED_SELECTED_BIBLIOGRA"><h2 id="_Elafibranor_ANNOTATED_SELECTED_BIBLIOGRA_">ANNOTATED SELECTED BIBLIOGRAPHY</h2><p>References updated: 24 July 2024</p><p>Abbreviations: NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; PBC, primary biliary cholangitis (cirrhosis); PPAR, peroxisome proliferator-activated receptor; PSC, primary sclerosing cholangitis.</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Elafibranor.REF.zimmerman.1999">Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999.<div><i>(Review of hepatotoxicity published in 1999 before the availability of PPAR agonists).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.powers.2018">Powers AC, D’Alessio D. Thiazolidinediones: Endocrine pancreas and pharmacotherapy of diabetes mellitus and hypoglycemia. In, Brunton LL, Halal R, Knollman BC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 876-7.<div><i>(Textbook of pharmacology and therapeutics, discusses PPAR-gamma agonists only).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.fda.2024">FDA. 2024. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/218860Orig1s000IntegratedR.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.accessdata<wbr style="display:inline-block"></wbr>​.fda.gov/drugsatfda_docs<wbr style="display:inline-block"></wbr>​/nda/2024/218860Orig1s000IntegratedR.pdf</a><div><i>(FDA website with product label and integrated clinical review of data on elafibranor provided by the sponsor in support of its approval as therapy of primary biliary cholangitis [PBC], mentions that serum aminotransferase elevations were common with high doses of elafibranor [above 120 mg daily] and were occasionally seen with recommended doses [1%-2%], but there were no episodes of definite drug induced liver injury in the preregistration trials).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.iwasaki.2008.557">Iwasaki
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S, Ohira
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H, Nishiguchi
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S, Zeniya
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M, Kaneko
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S, Onji
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M, Ishibashi
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H, et al.; Study Group of Intractable Liver Diseases for Research on a Specific Disease, Health Science Research Grant, Ministry of Health, Labour and Welfare of Japan. The efficacy of ursodeoxycholic acid and bezafibrate combination therapy for primary biliary cirrhosis: A prospective, multicenter study.
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Hepatol Res.
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2008;38:557-64.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/18452482" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18452482</span></a>]<div><i>(Study one: Among 45 patients with PBC treated with either bezafibrate or ursodiol, serum Alk P levels improved similarly in both groups and were within normal limits in 58% vs 38% by 24 weeks. Study two: Among 21 patients with PBC with an incomplete response to ursodiol, addition of bezafibrate led to further improvements in Alk P levels that were within normal limits in 60% by week 24 but remained elevated in all who did not have bezafibrate added; no mention of worsening liver tests, but 3 of 31 bezafibrate treated subjects developed CPK elevations).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.levy.2011.235">Levy
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C, Peter
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JA, Nelson
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[<a href="https://pubmed.ncbi.nlm.nih.gov/21083674" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21083674</span></a>]<div><i>(Among 20 patients with an incomplete response to ursodiol treated with addition of fenofibrate [160 mg/day] for 48 weeks, Alk P levels decreased [median 351 to 171 U/L] as did AST and IgM levels, while pruritus rates did not change and adverse events included heartburn [25%] and transient, early 2- to 5-fold increases in ALT and AST [10%] but no clinically apparent liver injury with jaundice).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.reig.2018.49">Reig
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A, Sesé
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P, Parés
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A. Effects of bezafibrate on outcome and pruritus in primary biliary cholangitis with suboptimal ursodeoxycholic acid response.
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Am J Gastroenterol.
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2018;113:49-55.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/29016567" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29016567</span></a>]<div><i>(Among 48 patients with PBC with an incomplete response to ursodiol who had the addition of bezafibrate, alkaline phosphatase fell into the normal range in 26 [54%] who also had improvements in itching and subsequently suffered no serious clinical outcomes [liver decompensation, cancer, death or liver transplantation], while the 22 not achieving normal alkaline phosphatase levels had less improvement in itching and 5 instances of serious clinical outcomes).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.corpechot.2018.2171">Corpechot
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C, Chazouillères
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O, Rousseau
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A, Le Gruyer
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A, Habersetzer
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F, Mathurin
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P, Goria
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O, et al.
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A placebo-controlled trial of bezafibrate in primary biliary cholangitis.
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N Engl J Med.
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2018;378:2171-2181.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/29874528" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29874528</span></a>]<div><i>(Among 100 patients with PBC and an incomplete response to ursodiol treated with bezafibrate or placebo for 24 months, Alk P levels fell into the normal range in 67% vs 2% and symptoms improved slightly, while adverse event rates were similar (49% vs 51%), including serious adverse events (28% vs 24%) and ALT elevations rising to 5 times ULN occurred in 6% vs 2%; 2 patients on bezafibrate having liver biopsy appearance of autoimmune hepatitis discontinued therapy and were treated successfully with corticosteroids).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.honda.2019.2035">Honda
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A, Tanaka
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A, Kaneko
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T, Komori
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A, Abe
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M, Inao
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M, Namisaki
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T, et al.; Japan PBC Study Group. Bezafibrate improves GLOBE and UK-PBC scores and long-term outcomes in patients with primary biliary cholangitis.
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Hepatology.
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2019;70:2035-2046.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/30737815" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30737815</span></a>]<div><i>(Among 118 Japanese patients with PBC treated with ursodiol for at least a year followed by its combination with bezafibrate for a year, there was no decrease in risk of clinical outcomes but there were changes in risk scores that predicted fewer outcome in the future).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.lleo.2020.1915">Lleo
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A, Wang
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GQ, Gershwin
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ME, Hirschfield
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GM. Primary biliary cholangitis.
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Lancet.
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2020;396(10266):1915-1926.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/33308474" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33308474</span></a>]<div><i>(Review of the clinical features, diagnosis, natural history, etiology, and therapy of PBC; no mention of hepatoxicity of medications used in treatment).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.de_vries.2021.734">de Vries
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E, Bolier
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R, Goet
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J, Parés
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A, Verbeek
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J, de Vree
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M, Drenth
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J, et al.; Netherlands Association for the Study of the Liver-Cholestasis Working Group. Fibrates for itch (FITCH) in fibrosing cholangiopathies: a double-blind, randomized, placebo-controlled trial.
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Gastroenterology.
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2021;160:734-743.e6.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/33031833" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33031833</span></a>]<div><i>(Among 74 patients with moderate-to-severe pruritus due to chronic cholestatic liver disease treated with bezafibrate or placebo for 21 days, serum alkaline phosphatase levels and pruritus decreased with bezafibrate but not placebo and there were no serious adverse events or episodes of worsening of serum liver enzymes).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.sorda.2021.1202">Sorda
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JA, González Ballerga
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E, Barreyro
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FJ, Avagnina
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A, Carballo
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P, Paes de Lima
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A, et al.
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Bezafibrate therapy in primary biliary cholangitis refractory to ursodeoxycholic acid: a longitudinal study of paired liver biopsies at 5 years of follow up.
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Aliment Pharmacol Ther.
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2021;54:1202-1212.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/34587309" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34587309</span></a>]<div><i>(Among 49 patients with PBC and an incomplete response to ursodiol who were treated with addition of bezafibrate, serum Alk P levels fell into the normal range in 86% by 1 year and repeat liver biopsies in 31 patients at 5 years showed a decrease in fibrosis in 48% and decline in cirrhosis rate from 19% to 3%).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.ratziu.2016.1147">Ratziu
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V, Harrison
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SA, Francque
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S, Bedossa
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P, Lehert
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P, Serfaty
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L, Romero-Gomez
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M, et al.; GOLDEN-505 Investigator Study Group. Elafibranor, an agonist of the peroxisome proliferator-activated receptor-α and -δ, induces resolution of nonalcoholic steatohepatitis without fibrosis worsening.
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Gastroenterology.
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2016;150:1147-1159.e5.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/26874076" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26874076</span></a>]<div><i>(Among 276 patients with nonalcoholic steatohepatitis [NASH] without cirrhosis treated with elafibranor [80 and 120 mg] or placebo once daily for 52 weeks, there were no differences in rates of NASH resolution in the 3 groups although serum alkaline phosphatase and GGT levels decreased more on elafibranor, while rates of adverse events were similar in the 3 groups, those on elafibranor were more likely to have nausea, vomiting, diarrhea, renal impairment, myalgia, decreased appetite, and rash; no mention of worsening of ALT or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.schattenberg.2021.1344">Schattenberg
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JM, Pares
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A, Kowdley
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KV, Heneghan
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MA, Caldwell
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S, Pratt
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D, Bonder
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A, et al.
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A randomized placebo- controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA.
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J Hepatol.
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2021;74:1344-1354.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/33484775" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33484775</span></a>]<div><i>(Among 45 patients with PBC and an incomplete response to ursodiol treated with elafibranor [80 or 120 mg] or placebo once daily for 12 weeks, serum levels of alkaline phosphatase and GGT decreased with elafibranor but not placebo therapy, while there was little change in symptoms or ALT levels and adverse event rates were similar in all 3 groups although 2 patients receiving elafibranor developed elevations in ALT, both of whom stopped therapy, one received corticosteroids).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.kamata.2023.1523">Kamata
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S, Honda
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A, Ishikawa
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R, Akahane
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M, Fujita
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A, Kaneko
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S, et al.
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Functional and structural insights into the human PPARα/δ/γ targeting preferences of anti-NASH investigational drugs, lanifibranor, seladelpar, and elafibranor.
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[<a href="/pmc/articles/PMC10451623/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10451623</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/37627519" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37627519</span></a>]<div><i>(Functional assays for PPARα, δ, and γ binding and activity demonstrate that elafibranor binds to and activates all three subtypes of PPAR, inducing antioxidant genes, as well as mediators of pathways of lipid and glucose metabolism and inflammation).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.jorge_nardelli.2023.413">Jorge Nardelli
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M, Rodrigues Maffia
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L, Alves Gelape
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F, Grossi Lopes Cançado
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G, Alves Couto
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J Gastrointestin Liver Dis.
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2023;32:413-414.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/37774223" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37774223</span></a>]<div><i>(65 year old woman developed AMA negative PBC with little response to ursodiol and a transient partial response to bezafibrate, eventually with progressive jaundice and death from liver failure interpreted as drug induced liver injury but with latency of several years, no dechallenge on stopping, and course compatible with progressive PBC and lack of sustained response to bezafibrate).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.cheung.2016.283">Cheung
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AC, Lapointe-Shaw
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L, Kowgier
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M, Meza-Cardona
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GM, Janssen
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HL, Feld
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JJ. Combined ursodeoxycholic acid (UDCA) and fenofibrate in primary biliary cholangitis patients with incomplete UDCA response may improve outcomes.
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Aliment Pharmacol Ther.
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2016;43:283-93.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/26559762" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26559762</span></a>]<div><i>(In a retrospective analysis, comparison of patients with PBC treated with ursodiol alone [n=66] or combined with fenofibrate [n=66: cohorts matched for age, cirrhosis, Alk P, bilirubin and platelet counts] for a median of 11 months demonstrated greater decreases in Alk P levels and improved decompensation- and transplant-free survival with fenofibrate, but 1 patient developed ALT elevations above 5 times ULN after 5.4 years which resolved upon stopping).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.hegade.2016.3037">Hegade
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VS, Khanna
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LJ, Wong
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LL, Dyson
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DEJ. Long-term fenofibrate treatment in primary biliary cholangitis improves biochemistry but not the UK-PBC risk score.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/27435324" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27435324</span></a>]<div><i>(Among 23 patients with PBC and an incomplete response to ursodiol who were treated with the addition of fenofibrate [200 mg daily] for a median of 21 months, there were sustained improvements in Alk P levels, but no improvement in the UK-PBC risk scores for decreasing liver-related deaths or liver transplantations).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.ghonem.2020.1213">Ghonem
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NS, Auclair
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AM, Hemme
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CL, Gallucci
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GM, de la Rosa Rodriguez
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R, Boyer
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JL, Assis
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DN. Fenofibrate improves liver function and reduces the toxicity of the bile acid pool in patients with primary biliary cholangitis and primary sclerosing cholangitis who are partial responders to ursodiol.
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Clin Pharmacol Ther.
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2020;108:1213-1223.
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[<a href="/pmc/articles/PMC7886378/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7886378</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/32480421" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32480421</span></a>]<div><i>(In a retrospective analysis of 31 patients with PBC or PSC with an incomplete response to ursodiol therapy who had the addition of fenofibrate [160 mg daily], alkaline phosphatase levels fell into the normal range in 84% and total serum bile acid levels improved as well).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.liu.2023.1973">Liu
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Y, Guo
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G, Zheng
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L, Sun
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R, Wang
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X, Deng
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J, Jia
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G, et al.
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Effectiveness of fenofibrate in treatment-naive patients with primary biliary cholangitis: a randomized clinical trial.
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Am J Gastroenterol.
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2023;118:1973-1979.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/36892506" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36892506</span></a>]<div><i>(Among 117 Chinese patients with newly diagnosed PBC treated with ursodiol alone vs urso and fenofibrate [200 mg daily] for 12 months, Alk P fell into the normal range in 40% vs 62% by 12 months, while ALT elevations arose in 8% vs 19%, none were above 5 times ULN and all resolved spontaneously).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.tanaka.2024.102358">Tanaka
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A, Corpechot
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C.
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PPAR agonists in PBC: where do we go from here? or how to choose between the new and the old.
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Clin Res Hepatol Gastroenterol.
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2024;48:102358.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/38677506" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 38677506</span></a>]<div><i>(Review of recent phase 3 trials of seladelpar and elafibranor [PPAR agonists] demonstrating achievement of endpoint of improvements in serum alkaline phosphatase but not a decrease in long term complications of PBC, whereas the many trials of bezafibrate with long term follow up have shown improvements in alkaline phosphatase levels and also liver histology, fibrosis, and in mortality and need for liver transplantation).</i></div></div></li><li><div class="bk_ref" id="Elafibranor.REF.kowdley.2024.795">Kowdley
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KV, Bowlus
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CL, Levy
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C, Akarca
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US, Alvares-da-Silva
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MR, Andreone
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P, Arrese
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M, et al; ELATIVE Study Investigators’ Group; ELATIVE Study Investigators' Group. Efficacy and safety of elafibranor in primary biliary cholangitis.
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N Engl J Med.
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2024;390:795-805.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/37962077" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37962077</span></a>]<div><i>(Among 161 patients with PBC and an incomplete response to ursodiol treated with elafibranor [80 mg] or placebo for 52 weeks, improvements in alkaline phosphatase to less than 167 U/L occurred in 51% of those on elafibranor vs 4% on placebo, and while total [96% vs 91%] and serious adverse event rates [11% vs 11%] were similar in the 2 groups, those on elafibranor were more likely to have abdominal pain [11% vs 6%], diarrhea [11% vs 9%], nausea [11% vs 6%] and vomiting [11% vs 2%], and 1 patient on elafibranor developed possible and 2 on placebo developed probable drug induced liver injury).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK605979_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">July 24, 2024</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a></div></div><h3>Publisher</h3><p><a href="https://www.niddk.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Diabetes and Digestive and Kidney Diseases</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Elafibranor. [Updated 2024 Jul 24].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Elacestrant/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/livertox/Elagolix/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article><article data-type="table-wrap" id="figobElafibranorTc"><div id="Elafibranor.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK605979/table/Elafibranor.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Elafibranor.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Elafibranor.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Elafibranor.Tc_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_Elafibranor.Tc_1_1_1_3" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Elafibranor.Tc_1_1_1_4" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Elafibranor.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Elafibranor</td><td headers="hd_h_Elafibranor.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/249748714" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">923978-27-2</a>
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</td><td headers="hd_h_Elafibranor.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C22-H24-O4-S</td><td headers="hd_h_Elafibranor.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/249748714" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=249748714" alt="image 249748714 in the ncbi pubchem database" /></a>
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</td></tr><tr><td headers="hd_h_Elafibranor.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bezafibrate</td><td headers="hd_h_Elafibranor.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135001112" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">41859-67-0</a>
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</td><td headers="hd_h_Elafibranor.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C19-H20-ClNO4</td><td headers="hd_h_Elafibranor.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135001112" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=135001112" alt="image 135001112 in the ncbi pubchem database" /></a>
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</td></tr><tr><td headers="hd_h_Elafibranor.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Fenofibrate</td><td headers="hd_h_Elafibranor.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135000744" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">49562-28-9</a>
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</td><td headers="hd_h_Elafibranor.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C20-H21-ClO4</td><td headers="hd_h_Elafibranor.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135000744" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=135000744" alt="image 135000744 in the ncbi pubchem database" /></a>
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