Houri I, Hirschfield GM. Primary biliary cholangitis: pathophysiology. Clin Liver Dis. 2024;28(1):79–92.

Article  PubMed  Google Scholar 

Tanaka A. New therapies on the horizon for primary biliary cholangitis. Drugs. 2024;84(1):1–15.

Article  CAS  PubMed  Google Scholar 

Wetten A, Jones DEJ, Dyson JK. Seladelpar: an investigational drug for the treatment of early-stage primary biliary cholangitis (PBC). Expert Opin Investig Drugs. 2022;31(10):1101–7.

Article  CAS  PubMed  Google Scholar 

Colapietro F, Gershwin ME, Lleo A. PPAR agonists for the treatment of primary biliary cholangitis: old and new tales. J Transl Autoimmun. 2023;6:1–9.

Article  Google Scholar 

Tanaka A, Ma X, Takahashi A, et al. Primary biliary cholangitis. Lancet. 2024;404(10457):1053–66.

Article  CAS  PubMed  Google Scholar 

Ma D, Ma J, Zhao C, et al. Reasons why women are more likely to develop primary biliary cholangitis. Heliyon. 2024;10(4): e25634.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Levy C, Manns M, Hirschfield G. New treatment paradigms in primary biliary cholangitis. Clin Gastroenterol Hepatol. 2023;21(8):2076–87.

Article  CAS  PubMed  Google Scholar 

Lindor KD, Bowlus CL, Boyer J, et al. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394–419.

Article  PubMed  Google Scholar 

Bionews Inc. Cholangitis treatment and management options [media release]. 16 Aug 2024. https://liverdiseasenews.com/cholangitis-treatment-options/.

Yang C, Guo G, Li B, et al. Prediction and evaluation of high-risk patients with primary biliary cholangitis receiving ursodeoxycholic acid therapy: an early criterion. Hepatol Int. 2023;17(1):237–48.

Article  PubMed  Google Scholar 

Lindor KD, Bowlus CL, Boyer J, et al. Primary biliary cholangitis: 2021 practice guidance update from the American Association for the Study of Liver Diseases. Hepatology. 2022;75(4):1012–3.

Article  PubMed  Google Scholar 

US FDA. Due to risk of serious liver injury, FDA restricts use of Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) patients with advanced cirrhosis. 2021. https://www.fda.gov/drugs/drug-safety-and-availability/due-risk-serious-liver-injury-fda-restricts-use-ocaliva-obeticholic-acid-primary-biliary-cholangitis. Accessed 30 Oct 2024.

MedPage Today. Approved liver disease drug has no clinical benefit, FDA panel says [media release]. 13 Sep 2024. https://www.medpagetoday.com/gastroenterology/generalhepatology/111955.

Gilead Sciences Inc. LIVDELZI® (seladelpar) capsules, for oral use: US prescribing information. 2024. https://www.fda.gov/. Accessed 30 Oct 2024.

Gilead Sciences Inc. Gilead’s Livdelzi (seladelpar) granted accelerated approval for primary biliary cholangitis by US FDA [media release]. 14 Aug 2024. https://www.gilead.com/.

CymaBay Therapeutics Inc. CymaBay announces European Medicines Agency accepts for review the Marketing Authorization Application for seladelpar for the treatment of primary biliary cholangitis [media release]. 4 Mar 2024. http://www.cymabay.com.

CymaBay Therapeutics Inc. CymaBay reports fourth quarter and year ended December 31, 2023 financial results and provides corporate update [media release]. 28 Feb 2024. http://www.cymabay.com.

Gilead Sciences Inc. Gilead Sciences pipeline. 2024. https://www.gilead.com/science-and-medicine/pipeline. Accessed 30 Oct 2024.

Metabolex Inc. Metabolex enters into a comprehensive development and commercialization agreement with Ortho-McNeil, Inc. for drugs for metabolic diseases [media release]. 26 Jun 2006. http://www.metabolex.com.

United States Securities and Exchange Commission. FORM 10-K: annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2020. 2020. https://www.sec.gov/ix?doc=/Archives/edgar/data/1042074/000119312521094424/d41924d10k.htm. Accessed 30 Oct 2024.

CymaBay Therapeutics Inc., Kaken Pharmaceutical Co. Ltd. CymaBay Therapeutics announces collaboration with Kaken Pharmaceutical Co., Ltd. to develop and commercialize seladelpar in Japan for primary biliary cholangitis [media release]. 8 Jan 2023. http://www.cymabay.com.

Gilead Sciences Inc. Gilead Sciences announces completion of acquisition of CymaBay [media release]. 22 Mar 2024. http://www.gilead.com.

United States Securities and Exchange Commission. FORM 10-Q: quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2024. 2024. https://s29.q4cdn.com/585078350/files/doc_financials/2024/q2/407db84d-4ebd-4632-8eb3-c0742a1210c0.pdf. Accessed 30 Oct 2024.

Kouno T, Liu X, Zhao H, et al. Selective PPARδ agonist seladelpar suppresses bile acid synthesis by reducing hepatocyte CYP7A1 via the fibroblast growth factor 21 signaling pathway. J Biol Chem. 2022;298(7):1–11.

Article  Google Scholar 

Kamata S, Honda A, Ishikawa R, 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(8):1–17.

Google Scholar 

Choi YJ, Johnson JD, Schwab A, et al. Seladelpar, a PPAR-delta agonist, improves inflammatory lipid mediators in the serum metabolome in patients with primary biliary cholangitis (PBC) [abstract no. 4731]. Hepatology. 2022;76:S1487.

Choi Y, Johnson J, McWherter CA. Seladelpar treatment increases fatty acid beta-oxidation and serum carnitine levels in patients with primary biliary cholangitis consistent with increased expression of the carnitine transporter OCTN2 and the mitochondrial carnitine shuttle [abstract no. THU-119]. J Hepatol. 2024;80(Suppl 1):S319.

Wu X, Chen Y, Song J, et al. PPAR-delta activation with seladelpar regulates cholangiocyte inflammation [abstract no. SAT-175]. J Hepatol. 2024;80(Suppl 1):S300.

Bowlus CL, Choi YJ, Yang K, et al. Seladelpar improved the lipid profile of patients with primary biliary cholangitis (PBC): results from phase 2 and 3 clinical studies [abstract no. 4759]. Hepatology. 2022;76:S1508.

Kremer AE, Mayo MJ, Hirschfield GM, et al. Seladelpar treatment reduces IL-31 and pruritus in patients with primary biliary cholangitis. Hepatology. 2024;80(1):27–37.

Article  PubMed  Google Scholar 

Hirschfield GM, Bowlus CL, Mayo MJ, et al. A phase 3 trial of seladelpar in primary biliary cholangitis. N Engl J Med. 2024;390(9):783–94.

Article  CAS  PubMed  Google Scholar 

Hirschfield GM, Shiffman ML, Gulamhusein A, et al. Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study. Hepatology. 2023;78(2):397–415.

Article  PubMed  Google Scholar 

Mayo MJ, Vierling JM, Bowlus CL, 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(2):186–200.

Article  CAS  PubMed  Google Scholar 

CymaBay Therapeutics Inc. CymaBay reports third quarter 2020 financial results and provides corporate update [media release]. 6 Nov 2020. http://www.cymabay.com.

Trivedi PJ, Levy C, Kowdley KV, et al. Long-term efficacy and safety of open-label seladelpar treatment in patients with primary biliary cholangitis (PBC): interim results for 2 years from the ASSURE study [abstract no. LBP-040]. J Hepatol. 2024;80(Suppl 1):S98.

Bowlus CL, Galambos MR, Aspinall RJ, et al. A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis. J Hepatol. 2022;77(2):353–64.

Article  CAS  PubMed  Google Scholar 

Jones D, Boudes PF, Swain MG, 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(10):716–26.

Article  PubMed  Google Scholar 

Gordon SC, Trivedi P, Bowlus CL, et al. Efficacy, safety, and tolerability of seladelpar in patients with compensated liver cirrhosis due to primary biliary cholangitis (PBC): a pooled analysis of phase 2 and phase 3 studies [abstract no. Su1348]. Gastroenterology. 2022;162(7 Suppl):S1191.

CymaBay Therapeutics Inc. FDA lifts all clinical holds on seladelpar [media release]. 23 Jul 2020. http://www.cymabay.com.