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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. </p></div><div class="iconblock clearfix whole_rhythm no_top_margin bk_noprnt"><a class="img_link icnblk_img" title="All Drug Records" href="/books/n/livertox/"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png" alt="Cover of LiverTox" height="100px" width="80px" /></a><div class="icnblk_cntnt eight_col"><h2>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].</h2><a data-jig="ncbitoggler" href="#__NBK608065_dtls__">Show details</a><div style="display:none" class="ui-widget" id="__NBK608065_dtls__"><div>Bethesda (MD): <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>; 2012-.</div></div><div class="half_rhythm"><ul class="inline_list"><li style="margin-right:1em"><a class="bk_cntns" href="/books/n/livertox/">Drug Records</a></li></ul></div><div class="bk_noprnt"><form method="get" action="/books/n/livertox/" id="bk_srch"><div class="bk_search"><label for="bk_term" class="offscreen_noflow">Search term</label><input type="text" title="Search this book" id="bk_term" name="term" value="" data-jig="ncbiclearbutton" /> <input type="submit" class="jig-ncbibutton" value="Search this book" submit="false" style="padding: 0.1em 0.4em;" /></div></form></div></div><div class="icnblk_cntnt two_col"><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/livertox/Sedatives_Hypnotics/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/livertox/SERMS/" title="Next page in this title">Next ></a></div></div></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK608065_"><span class="title" itemprop="name">Seladelpar</span></h1><p class="small">Last Update: <span itemprop="dateModified">September 18, 2024</span>.</p></div><div class="body-content whole_rhythm" itemprop="text"><div id="Seladelpar.OVERVIEW"><h2 id="_Seladelpar_OVERVIEW_">OVERVIEW</h2><div id="Seladelpar.Introduction"><h3>Introduction</h3><p>Seladelpar is an orally available peroxisome proliferator-activated receptor delta (PPARδ) agonist that is used in combination with ursodeoxycholic acid to treat primary biliary cholangitis (PBC). Seladelpar 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="Seladelpar.Background"><h3>Background</h3><p>Seladelpar (sel’ a del’ par) is an agonist of the peroxisome proliferator-activated receptor delta (PPARδ) that is approved for use in primary biliary cholangitis (PBC). The PPARs (α, β, and δ) are intracellular receptors that have 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 PBC and is approved for this use in Europe and Japan. PBC is a chronic liver disease that occurs most commonly in middle aged women and is characterized by gradual inflammatory destruction of small bile ducts that slowly leads to cirrhosis and end-stage liver disease. The first line approved therapy of PBC is use of ursodeoxycholic acid (ursodiol), a hydrophilic bile acid, which has been shown to improve liver tests results and slow progression of disease. Seladelpar also has now been shown to improve serum enzymes and symptoms in patients with PBC. In a large, placebo-controlled trial in patients with PBC and an incomplete response to ursodiol, seladelpar therapy was associated with significant improvements in serum alkaline phosphatase levels in 62% of treated patients compared to only 20% of placebo recipients. Furthermore, alkaline phosphatase levels became normal in 25% receiving seladelpar vs none on placebo. Treatment was also associated with improvements in symptoms of pruritus and in serum lipids. Based upon its effects on alkaline phosphatase levels, seladelpar was granted accelerated approval in 2024 for treatment of adults with PBC who have an inadequate response to or intolerance of ursodiol. Seladelpar is typically given in combination with ursodiol but can be given as monotherapy in those with intolerance to ursodiol. Seladelpar 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. Seladelpar is available as capsules of 10 mg under the brand name Livdelzi. The recommended dose is 10 mg once daily. Seladelpar is not recommended for patients with advanced or decompensated cirrhosis, or complete biliary obstruction. Common adverse events include headache, abdominal pain and distension, nausea, indigestion, rash, and dizziness. Uncommon but potentially severe adverse events include bone fractures and hypersensitivity reactions. Seladelpar has not been evaluated in pregnancy, and women of childbearing potential should be tested for pregnancy before starting seladelpar and practice an effective means of birth control during therapy.</p></div><div id="Seladelpar.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In preregistration clinical trials, seladelpar was found to decrease both serum aminotransferase and alkaline phosphatase elevations in a high proportion of patients with PBC. However, in preliminary dose-finding studies in patients with PBC, transient elevations of <a class="def" href="/books/n/livertox/glossary/def-item/glossary.alanine-aminotransferase-alt-/">ALT</a> and <a class="def" href="/books/n/livertox/glossary/def-item/glossary.aspartate-aminotransferase-ast-/">AST</a> levels above 5 times the upper limit of normal (ULN) occurred in 3 of 25 subjects exposed to doses of 50 and 200 mg daily but in no placebo-treated patients. The elevations occurred during the few months of therapy and resolved rapidly upon drug discontinuation. Interestingly, alkaline phosphatase levels decreased markedly during the ALT elevations and rose to pretreatment levels soon after discontinuation.</p><p>In contrast, in subsequent clinical trials of seladelpar in doses of 10 mg daily in patients with PBC, <a class="def" href="/books/n/livertox/glossary/def-item/glossary.alanine-aminotransferase-alt-/">ALT</a> elevations above 5 times ULN were rare, occurred randomly, and were usually attributable to other causes. In the major preregistration randomized placebo-controlled trial, drug discontinuations because of liver test abnormalities arose in 2 of 128 patients [1.6%] receiving seladelpar vs 2 of 65 [3.1%] on placebo. In multiple small clinical trials, there were no episodes of clinically apparent liver injury that were considered due to seladelpar. However, the total clinical experience with seladelpar has been limited, and rare instances of drug induced liver injury are known to occur with other PPAR agonists, such as fenofibrate, bezafibrate, pioglitazone and rosiglitazone. In long term extension studies, decompensation and jaundice arose in a small number of patients taking seladelpar, but in all instances these outcomes arose in patients with preexisting cirrhosis and were interpreted as due to disease progression independent of therapy. Nevertheless, seladelpar and other PPAR agonists are not recommended for patients with advanced or decompensated cirrhosis, and routine monitoring of liver tests is recommended during therapy.</p><p><a class="def" href="/books/n/livertox/glossary/def-item/glossary.likelihood-score/">Likelihood score</a>: E* (unproven but suspected rare cause of clinically apparent liver injury).</p></div><div id="Seladelpar.Mechanism_of_Liver_Injury"><h3>Mechanism of Liver Injury</h3><p>The mechanism by which seladelpar might cause liver injury is unclear, but clinically apparent liver injury from other fibrates and PPAR agonists is likely immune mediated. Seladelpar is metabolized in the liver by multiple CYP isoenzymes and is susceptible to drug-drug interactions with strong inhibitors or inducers of CYP2C9.</p></div><div id="Seladelpar.Outcome_and_Management"><h3>Outcome and Management</h3><p>The product label for seladelpar 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 seladelpar, therapy should be permanently discontinued. There is little or no information on cross sensitivity to liver injury or adverse events between seladelpar and other therapies for PBC such as ursodiol, obeticholic acid, elafibranor, and fenofibrate.</p><p>Drug Class: Liver Disease Agents; <a href="/books/n/livertox/ObeticholicAcid/">Obeticholic Acid</a>, <a href="/books/n/livertox/Ursodiol/">Ursodiol</a></p><p>Other PPAR Agonists: Bezafibrate, <a href="/books/n/livertox/Elafibranor/">Elafibranor</a>, <a href="/books/n/livertox/Fenofibrate/">Fenofibrate</a>, <a href="/books/n/livertox/Pioglitazone/">Pioglitazone</a>, <a href="/books/n/livertox/Rosiglitazone/">Rosiglitazone</a></p></div></div><div id="Seladelpar.PRODUCT_INFORMATION"><h2 id="_Seladelpar_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
|
||
<b>REPRESENTATIVE TRADE NAMES</b>
|
||
</p><p>Seladelpar – Livdelzi®</p><p>
|
||
<b>DRUG CLASS</b>
|
||
</p><p>Liver Disease Agents</p><p>
|
||
<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Seladelpar" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
|
||
</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div><div id="Seladelpar.CHEMICAL_FORMULAS_AND_STRUCTU"><h2 id="_Seladelpar_CHEMICAL_FORMULAS_AND_STRUCTU_">CHEMICAL FORMULAS AND STRUCTURES</h2><div id="Seladelpar.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK608065/table/Seladelpar.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Seladelpar.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Seladelpar.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Seladelpar.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_Seladelpar.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_Seladelpar.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_Seladelpar.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Seladelpar</td><td headers="hd_h_Seladelpar.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">851528-79-5</td><td headers="hd_h_Seladelpar.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C21-H23-F3-O5-S</td><td headers="hd_h_Seladelpar.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/295371087" 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=295371087" alt="image 295371087 in the ncbi pubchem database" /></a>
|
||
</td></tr><tr><td headers="hd_h_Seladelpar.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Elafibranor</td><td headers="hd_h_Seladelpar.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/249748714" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">923978-27-2</a>
|
||
</td><td headers="hd_h_Seladelpar.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_Seladelpar.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<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>
|
||
</td></tr><tr><td headers="hd_h_Seladelpar.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bezafibrate</td><td headers="hd_h_Seladelpar.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135001112" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">41859-67-0</a>
|
||
</td><td headers="hd_h_Seladelpar.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C19-H20-ClNO4</td><td headers="hd_h_Seladelpar.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<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>
|
||
</td></tr><tr><td headers="hd_h_Seladelpar.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Fenofibrate</td><td headers="hd_h_Seladelpar.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135000744" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">49562-28-9</a>
|
||
</td><td headers="hd_h_Seladelpar.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C20-H21-ClO4</td><td headers="hd_h_Seladelpar.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<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>
|
||
</td></tr></tbody></table></div></div></div><div id="Seladelpar.ANNOTATED_SELECTED_BIBLIOGRAP"><h2 id="_Seladelpar_ANNOTATED_SELECTED_BIBLIOGRAP_">ANNOTATED SELECTED BIBLIOGRAPHY</h2><p>References updated: 18 September 2024</p><p>Abbreviations: 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="Seladelpar.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="Seladelpar.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="Seladelpar.REF3">FDA. Integrated Review. 2024. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217899Orig1s000IntegratedR.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/2024/217899Orig1s000IntegratedR.pdf</a><div><i>(FDA website with product label and integrated clinical review of data on seladelpar provided by the sponsor in support of its approval as therapy of primary biliary cholangitis [PBC], mentions that serum aminotransferase elevations occurred with high doses of seladelpar (50 and 200 mg daily) but were not observed with the currently recommended dosage (10 mg daily); nevertheless, instances of hepatic decompensation did occur in some patients with advanced cirrhosis treated with seladelpar and warnings were recommended for monitoring patients for liver test abnormalities before and during treatment, and not using seladelpar in patients with decompensated cirrhosis or complete biliary obstruction).</i></div></div></li><li><div class="bk_ref" id="Seladelpar.REF.iwasaki.2008.557">Iwasaki
|
||
S, Ohira
|
||
H, Nishiguchi
|
||
S, Zeniya
|
||
M, Kaneko
|
||
S, Onji
|
||
M, Ishibashi
|
||
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.
|
||
Hepatol Res.
|
||
2008;38:557-64.
|
||
[<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="Seladelpar.REF.levy.2011.235">Levy
|
||
C, Peter
|
||
JA, Nelson
|
||
DR, Keach
|
||
J, Petz
|
||
J, Cabrera
|
||
R, Clark
|
||
V, et al.
|
||
Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid.
|
||
Aliment Pharmacol Ther.
|
||
2011;33:235-42.
|
||
[<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="Seladelpar.REF.ratziu.2016.1147">Ratziu
|
||
V, Harrison
|
||
SA, Francque
|
||
S, Bedossa
|
||
P, Lehert
|
||
P, Serfaty
|
||
L, Romero-Gomez
|
||
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.
|
||
Gastroenterology.
|
||
2016;150:1147-1159.e5.
|
||
[<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="Seladelpar.REF.cheung.2016.283">Cheung
|
||
AC, Lapointe-Shaw
|
||
L, Kowgier
|
||
M, Meza-Cardona
|
||
J, Hirschfield
|
||
GM, Janssen
|
||
HL, Feld
|
||
JJ. Combined ursodeoxycholic acid (UDCA) and fenofibrate in primary biliary cholangitis patients with incomplete UDCA response may improve outcomes.
|
||
Aliment Pharmacol Ther.
|
||
2016;43:283-93.
|
||
[<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="Seladelpar.REF.hegade.2016.3037">Hegade
|
||
VS, Khanna
|
||
A, Walker
|
||
LJ, Wong
|
||
LL, Dyson
|
||
JK, Jones
|
||
DEJ. Long-term fenofibrate treatment in primary biliary cholangitis improves biochemistry but not the UK-PBC risk score.
|
||
Dig Dis Sci.
|
||
2016;61:3037-3044.
|
||
[<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="Seladelpar.REF.jones.2017.716">Jones
|
||
D, Boudes
|
||
PF, Swain
|
||
MG, Bowlus
|
||
CL, Galambos
|
||
MR, Bacon
|
||
BR, Doerffel
|
||
Y, et al.
|
||
Seladelpar (MBX-8025), a selective PPAR-δ agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study.
|
||
Lancet Gastroenterol Hepatol.
|
||
2017;2:716-726.
|
||
[<a href="https://pubmed.ncbi.nlm.nih.gov/28818518" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28818518</span></a>]<div><i>(Among 41 patients with PBC and an incomplete response to ursodiol treated with seladelpar [50 or 200 mg] or placebo daily, 3 treated patients developed marked elevations in serum ALT and AST without symptoms or jaundice within the first few weeks that reversed rapidly with discontinuation and that also led to the early termination of the trial, nevertheless by 12 weeks mean Alk P levels had decreased by 53% in seladelpar- vs only 2% in placebo-recipients).</i></div></div></li><li><div class="bk_ref" id="Seladelpar.REF.reig.2018.49">Reig
|
||
A, Sesé
|
||
P, Parés
|
||
A. Effects of bezafibrate on outcome and pruritus in primary biliary cholangitis with suboptimal ursodeoxycholic acid response.
|
||
Am J Gastroenterol.
|
||
2018;113:49-55.
|
||
[<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="Seladelpar.REF.corpechot.2018.2171">Corpechot
|
||
C, Chazouillères
|
||
O, Rousseau
|
||
A, Le Gruyer
|
||
A, Habersetzer
|
||
F, Mathurin
|
||
P, Goria
|
||
O, et al.
|
||
A placebo-controlled trial of bezafibrate in primary biliary cholangitis.
|
||
N Engl J Med.
|
||
2018;378:2171-2181.
|
||
[<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="Seladelpar.REF.honda.2019.2035">Honda
|
||
A, Tanaka
|
||
A, Kaneko
|
||
T, Komori
|
||
A, Abe
|
||
M, Inao
|
||
M, Namisaki
|
||
T, et al.; Japan PBC Study Group. Bezafibrate improves GLOBE and UK-PBC scores and long-term outcomes in patients with primary biliary cholangitis.
|
||
Hepatology.
|
||
2019;70:2035-2046.
|
||
[<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="Seladelpar.REF.lleo.2020.1915">Lleo
|
||
A, Wang
|
||
GQ, Gershwin
|
||
ME, Hirschfield
|
||
GM. Primary biliary cholangitis.
|
||
Lancet.
|
||
2020;396(10266):1915-1926.
|
||
[<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="Seladelpar.REF.ghonem.2020.1213">Ghonem
|
||
NS, Auclair
|
||
AM, Hemme
|
||
CL, Gallucci
|
||
GM, de la Rosa Rodriguez
|
||
R, Boyer
|
||
JL, Assis
|
||
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.
|
||
Clin Pharmacol Ther.
|
||
2020;108:1213-1223.
|
||
[<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="Seladelpar.REF.de_vries.2021.734">de Vries
|
||
E, Bolier
|
||
R, Goet
|
||
J, Parés
|
||
A, Verbeek
|
||
J, de Vree
|
||
M, Drenth
|
||
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.
|
||
Gastroenterology.
|
||
2021;160:734-743.e6.
|
||
[<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="Seladelpar.REF.sorda.2021.1202">Sorda
|
||
JA, González Ballerga
|
||
E, Barreyro
|
||
FJ, Avagnina
|
||
A, Carballo
|
||
P, Paes de Lima
|
||
A, et al.
|
||
Bezafibrate therapy in primary biliary cholangitis refractory to ursodeoxycholic acid: a longitudinal study of paired liver biopsies at 5 years of follow up.
|
||
Aliment Pharmacol Ther.
|
||
2021;54:1202-1212.
|
||
[<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="Seladelpar.REF.schattenberg.2021.1344">Schattenberg
|
||
JM, Pares
|
||
A, Kowdley
|
||
KV, Heneghan
|
||
MA, Caldwell
|
||
S, Pratt
|
||
D, Bonder
|
||
A, et al.
|
||
A randomized placebo- controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA.
|
||
J Hepatol.
|
||
2021;74:1344-1354.
|
||
[<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="Seladelpar.REF.bowlus.2022.353">Bowlus
|
||
CL, Galambos
|
||
MR, Aspinall
|
||
RJ, Hirschfield
|
||
GM, Jones
|
||
DEJ, Dörffel
|
||
Y, Gordon
|
||
SC, et al.
|
||
A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis.
|
||
J Hepatol.
|
||
2022;77:353-364.
|
||
[<a href="https://pubmed.ncbi.nlm.nih.gov/35367282" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35367282</span></a>]<div><i>(Among 119 patients with PBC and an incomplete response to ursodiol treated with seladelpar [2, 5, or 10 mg daily] for 52 weeks, there were dose related decreases in mean Alk P levels by 23% to 43% by 12 weeks and normalization of levels at 52 weeks with the 10 mg dose, while adverse events were generally mild, and although 3 patients developed episodes of ALT elevations, all 3 occurred after starting other drugs [rifampin or ibuprofen]).</i></div></div></li><li><div class="bk_ref" id="Seladelpar.REF.colapietro.2023.100188">Colapietro
|
||
F, Gershwin
|
||
ME, Lleo
|
||
A. PPAR agonists for the treatment of primary biliary cholangitis: Old and new tales.
|
||
J Transl Autoimmun.
|
||
2023;6:100188.
|
||
[<a href="/pmc/articles/PMC9850184/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9850184</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/36684809" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36684809</span></a>]<div><i>(Review of the clinical experience with use of PPAR agonists as therapy of PBC including beneficial results using bezafibrate, fenofibrate, seladelpar, and elafibranor mentions a single patient who discontinued seladelpar early because of serum ALT elevations above 3 times ULN).</i></div></div></li><li><div class="bk_ref" id="Seladelpar.REF.kamata.2023.1523">Kamata
|
||
S, Honda
|
||
A, Ishikawa
|
||
R, Akahane
|
||
M, Fujita
|
||
A, Kaneko
|
||
C, Miyawaki
|
||
S, et al.
|
||
Functional and structural insights into the human PPARα/δ/γ targeting preferences of anti-NASH investigational drugs, lanifibranor, seladelpar, and elafibranor.
|
||
Antioxidants (Basel). 2023;12:1523.
|
||
[<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="Seladelpar.REF.jorge_nardelli.2023.413">Jorge Nardelli
|
||
M, Rodrigues Maffia
|
||
L, Alves Gelape
|
||
F, Grossi Lopes Cançado
|
||
G, Alves Couto
|
||
C.
|
||
Bezafibrate severe late onset drug-induced liver injury in primary biliary cholangitis: case report.
|
||
J Gastrointestin Liver Dis.
|
||
2023;32:413-414.
|
||
[<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="Seladelpar.REF.liu.2023.1973">Liu
|
||
Y, Guo
|
||
G, Zheng
|
||
L, Sun
|
||
R, Wang
|
||
X, Deng
|
||
J, Jia
|
||
G, et al.
|
||
Effectiveness of fenofibrate in treatment-naive patients with primary biliary cholangitis: a randomized clinical trial.
|
||
Am J Gastroenterol.
|
||
2023;118:1973-1979.
|
||
[<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 ursodiol 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="Seladelpar.REF.tanaka.2024.102358">Tanaka
|
||
A, Corpechot
|
||
C.
|
||
PPAR agonists in PBC: where do we go from here? Or how to choose between the new and the old.
|
||
Clin Res Hepatol Gastroenterol.
|
||
2024;48:102358.
|
||
[<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="Seladelpar.REF.mayo.2024.186">Mayo
|
||
MJ, Vierling
|
||
JM, Bowlus
|
||
CL, Levy
|
||
C, Hirschfield
|
||
GM, Neff
|
||
GW, Galambos
|
||
MR, et al.
|
||
Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis.
|
||
Aliment Pharmacol Ther.
|
||
2024;59:186-200.
|
||
[<a href="https://pubmed.ncbi.nlm.nih.gov/37904314" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37904314</span></a>]<div><i>(Among 106 patients with PBC and an incomplete response to ursodiol who participated in early phase trials of seladelpar and were then enrolled in open-label extension studies, liver tests continued to improve over 2 years and there were no liver-related serious adverse events).</i></div></div></li><li><div class="bk_ref" id="Seladelpar.REF.hirschfield.2024.783">Hirschfield
|
||
GM, Bowlus
|
||
CL, Mayo
|
||
MJ, Kremer
|
||
AE, Vierling
|
||
JM, Kowdley
|
||
KV, Levy
|
||
C, et al.; RESPONSE Study Group. A phase 3 trial of seladelpar in primary biliary cholangitis.
|
||
N Engl J Med.
|
||
2024;390:783-794.
|
||
[<a href="https://pubmed.ncbi.nlm.nih.gov/38381664" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 38381664</span></a>]<div><i>(Among 193 patients with PBC and an incomplete response or intolerance to ursodiol treated with addition of seladelpar [10 mg] or placebo once daily for 12 months, Alk P levels improved more with seladelpar [-42% vs -4.3% from baseline] and fell into the normal range in 25% [vs none] with accompanying improvements in pruritus, while total and severe adverse event rates were similar and there were no treatment-related serious hepatic adverse events).</i></div></div></li><li><div class="bk_ref" id="Seladelpar.REF.kowdley.2024.795">Kowdley
|
||
KV, Bowlus
|
||
CL, Levy
|
||
C, Akarca
|
||
US, Alvares-da-Silva
|
||
MR, Andreone
|
||
P, Arrese
|
||
M, et al.; ELATIVE Study Investigators’ Group; ELATIVE Study Investigators' Group. Efficacy and safety of elafibranor in primary biliary cholangitis.
|
||
N Engl J Med.
|
||
2024;390:795-805.
|
||
[<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>
|
||
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<div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Views</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="PDF_download" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/NBK608065/?report=reader">PubReader</a></li><li><a href="/books/NBK608065/?report=printable">Print View</a></li><li><a data-jig="ncbidialog" href="#_ncbi_dlg_citbx_NBK608065" data-jigconfig="width:400,modal:true">Cite this Page</a><div id="_ncbi_dlg_citbx_NBK608065" style="display:none" title="Cite this Page"><div class="bk_tt">LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Seladelpar. 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Substances</div></li><li class="brieflinkpopper"><a class="brieflinkpopperctrl" href="/books/?Db=pubmed&DbFrom=books&Cmd=Link&LinkName=books_pubmed_refs&IdsFromResult=5681708" ref="log$=recordlinks">PubMed</a><div class="brieflinkpop offscreen_noflow">Links to PubMed</div></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Similar articles in PubMed</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="PBooksDiscovery_RA" id="Shutter"></a></div><div class="portlet_content"><ul><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/39159277" ref="ordinalpos=1&linkpos=1&log$=relatedreviews&logdbfrom=pubmed"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Elafibranor.</a><span class="source">[LiverTox: Clinical and Researc...]</span><div class="brieflinkpop offscreen_noflow"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Elafibranor.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. 2012</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/35367282" ref="ordinalpos=1&linkpos=2&log$=relatedarticles&logdbfrom=pubmed">A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis.</a><span class="source">[J Hepatol. 2022]</span><div class="brieflinkpop offscreen_noflow">A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Bowlus CL, Galambos MR, Aspinall RJ, Hirschfield GM, Jones DEJ, Dörffel Y, Gordon SC, Harrison SA, Kremer AE, Mayo MJ, et al. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">J Hepatol. 2022 Aug; 77(2):353-364. Epub 2022 Mar 30.</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/28818518" ref="ordinalpos=1&linkpos=3&log$=relatedarticles&logdbfrom=pubmed">Seladelpar (MBX-8025), a selective PPAR-δ agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study.</a><span class="source">[Lancet Gastroenterol Hepatol. ...]</span><div class="brieflinkpop offscreen_noflow">Seladelpar (MBX-8025), a selective PPAR-δ agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Jones D, Boudes PF, Swain MG, Bowlus CL, Galambos MR, Bacon BR, Doerffel Y, Gitlin N, Gordon SC, Odin JA, et al. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">Lancet Gastroenterol Hepatol. 2017 Oct; 2(10):716-726. 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<p><a href="https://www.nlm.nih.gov/web_policies.html" class="text-white">Web Policies</a><br />
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