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Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study.
Hirschfield GM, Shiffman ML, Gulamhusein A, Kowdley KV, Vierling JM, Levy C, Kremer AE, Zigmond E, Andreone P, Gordon SC, Bowlus CL, Lawitz EJ, Aspinall RJ, Pratt DS, Raikhelson K, Gonzalez-Huezo MS, Heneghan MA, Jeong SH, Ladrón de Guevara AL, Mayo MJ, Dalekos GN, Drenth JPH, Janczewska E, Leggett BA, Nevens F, Vargas V, Zuckerman E, Corpechot C, Fassio E, Hinrichsen H, Invernizzi P, Trivedi PJ, Forman L, Jones DEJ, Ryder SD, Swain MG, Steinberg A, Boudes PF, Choi YJ, McWherter CA; ENHANCE Study Group*. Hirschfield GM, et al. Hepatology. 2023 Aug 1;78(2):397-415. doi: 10.1097/HEP.0000000000000395. Epub 2023 Apr 6. Hepatology. 2023. PMID: 37386786 Free PMC article. Clinical Trial.
A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis.
Bowlus CL, Galambos MR, Aspinall RJ, Hirschfield GM, Jones DEJ, Dörffel Y, Gordon SC, Harrison SA, Kremer AE, Mayo MJ, Thuluvath PJ, Levy C, Swain MG, Neff GW, Sheridan DA, Stanca CM, Berg CP, Goel A, Shiffman ML, Vierling JM, Boudes P, Steinberg A, Choi YJ, McWherter CA. Bowlus CL, et al. Among authors: galambos mr. J Hepatol. 2022 Aug;77(2):353-364. doi: 10.1016/j.jhep.2022.02.033. Epub 2022 Mar 30. J Hepatol. 2022. PMID: 35367282 Free article. Clinical Trial.
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.
Jones D, Boudes PF, Swain MG, Bowlus CL, Galambos MR, Bacon BR, Doerffel Y, Gitlin N, Gordon SC, Odin JA, Sheridan D, Wörns MA, Clark V, Corless L, Hartmann H, Jonas ME, Kremer AE, Mells GF, Buggisch P, Freilich BL, Levy C, Vierling JM, Bernstein DE, Hartleb M, Janczewska E, Rochling F, Shah H, Shiffman ML, Smith JH, Choi YJ, Steinberg A, Varga M, Chera H, Martin R, McWherter CA, Hirschfield GM. Jones D, et al. Among authors: galambos mr. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):716-726. doi: 10.1016/S2468-1253(17)30246-7. Epub 2017 Aug 14. Lancet Gastroenterol Hepatol. 2017. PMID: 28818518 Clinical Trial.
Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis.
Mayo MJ, Vierling JM, Bowlus CL, Levy C, Hirschfield GM, Neff GW, Galambos MR, Gordon SC, Borg BB, Harrison SA, Thuluvath PJ, Goel A, Shiffman ML, Swain MG, Jones DEJ, Trivedi P, Kremer AE, Aspinall RJ, Sheridan DA, Dörffel Y, Yang K, Choi YJ, McWherter CA. Mayo MJ, et al. Among authors: galambos mr. Aliment Pharmacol Ther. 2024 Jan;59(2):186-200. doi: 10.1111/apt.17755. Epub 2023 Oct 30. Aliment Pharmacol Ther. 2024. PMID: 37904314