drugset
Drugs / SHP626
last change May 2026 re-read 3 minutes ago

SHP626

also known as Volixibat · Volixibat (SHP626)
Developed for
metabolic dysfunction-associated steatohepatitis
Investigated by
Mirum Pharmaceuticals, Inc.

Trials 2

today NCT02787304 · Ph 2 NCT02571192 · Ph 1
201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02571192 Oct 2015 metabolic dysfunction-associated steatohepatitis Mirum Pharmaceuticals, Inc. Completed No outcome recorded
Phase 21 trial · 1 missed
Phase 2 NCT02787304 Oct 2016 → Jul 2018 metabolic dysfunction-associated steatohepatitis Mirum Pharmaceuticals, Inc. Terminated Missed primary

Press releases naming this drug 11 releases

DateIssuerRelease
2026-05-04 Mirum Pharmaceuticals, Inc. Mirum Pharmaceuticals Announces Primary Endpoint Met in VISTAS Study of Volixibat in Patients with Primary Sclerosing Cholangitis mirumpharma.com ↗
2026-05-03 Mirum Pharmaceuticals, Inc. Mirum Pharmaceuticals to Host Investor Call to Share Topline Results from the VISTAS Study of Volixibat in Patients with Primary Sclerosing Cholangitis on May 4, 2026 mirumpharma.com ↗
2025-11-07 Mirum Pharmaceuticals, Inc. Mirum Pharmaceuticals Showcases Leadership in Liver Disease Innovation With Data From LIVMARLI® and Volixibat Clinical Programs at AASLD’s The Liver Meeting® mirumpharma.com ↗
2025-05-09 Mirum Pharmaceuticals, Inc. Volixibat Data from Mirum’s VANTAGE PBC Study Showcased at EASL mirumpharma.com ↗
2024-11-14 Mirum Pharmaceuticals, Inc. Mirum Pharmaceuticals to Showcase Data from its LIVMARLI and Volixibat Clinical Programs at AASLD’s The Liver Meeting mirumpharma.com ↗
2024-10-10 Mirum Pharmaceuticals, Inc. Volixibat Granted Breakthrough Therapy Designation for Cholestatic Pruritus in Primary Biliary Cholangitis mirumpharma.com ↗
2024-06-17 Mirum Pharmaceuticals, Inc. Mirum’s Volixibat Achieves Positive Interim Analyses in VANTAGE PBC and VISTAS PSC Studies mirumpharma.com ↗
2024-06-16 Mirum Pharmaceuticals, Inc. Mirum Pharmaceuticals to Host Investor Call to Share Interim Analysis Results from the Volixibat VANTAGE and VISTAS studies on June 17, 2024 mirumpharma.com ↗
2021-01-14 Mirum Pharmaceuticals, Inc. Mirum Pharmaceuticals Announces First Patient Enrolled in Phase 2b VISTAS Clinical Study Evaluating Volixibat in Adult Patients With Primary Sclerosing Cholangitis mirumpharma.com ↗
2020-11-13 Mirum Pharmaceuticals, Inc. Mirum Pharmaceuticals Presents New Data From Its Maralixibat and Volixibat Clinical Studies at AASLD Annual Meeting mirumpharma.com ↗
2016-07-29 Takeda Shire’s SHP626 (Volixibat) Receives FDA Fast Track Designation for an Investigational Treatment for Adults who have Nonalcoholic Steatohepatitis (NASH) with Liver Fibrosis takeda.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as SHP626 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02787304 ↗
1

NCT02571192 ↗
Known as Volixibat “Volixibat is a potent inhibitor of the apical sodium-dependent bile acid transporter in development for the treatment of nonalcoholic steatohepatitis.” PMID 28702877 ↗ Feb 2018
Known as Volixibat (SHP626) “Volixibat (SHP626)” NCT02787304 ↗
Action Inhibit “Volixibat is a potent inhibitor of the apical sodium-dependent bile acid transporter in development for the treatment of nonalcoholic steatohepatitis.” PMID 28702877 ↗ Feb 2018
Route Oral “received a single oral dose of [14C]-volixibat 50 mg containing ~5.95 µCi radioactivity” PMID 28702877 ↗ Feb 2018