Drugs / Volixibat

Trials 7 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT02571192 Oct 2015 metabolic dysfunction-associated steatohepatitis Mirum Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT02475317 Jun → Dec 2015 Mirum Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT02287779 Jan → Jun 2015 metabolic dysfunction-associated steatohepatitis Mirum Pharmaceuticals, Inc. Completed No outcome recorded
Phase 24 trials
Phase 2 NCT05050136 Sep 2021 → Apr 2027 expected primary biliary cholangitis Mirum Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 2 NCT04718961 Jan 2021 → Dec 2022 intrahepatic cholestasis of pregnancy Mirum Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 2 NCT04663308 Dec 2020 → Jun 2026 overdue primary sclerosing cholangitis Mirum Pharmaceuticals, Inc. Active not recruiting No outcome recorded
Phase 2 NCT02787304 Oct 2016 → Jul 2018 metabolic dysfunction-associated steatohepatitis Mirum Pharmaceuticals, Inc. Terminated No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
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 11 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as Volixibat “A randomised, double-blind, placebo-controlled phase 1 study of the safety, tolerability and pharmacodynamics of volixibat in overweight and obese but otherwise healthy adults:...” PMID 29548345 Mar 2018
5

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

NCT02475317

NCT04663308

NCT05050136

NCT04718961

Known as LUM-002 ChEMBL registry synonym — accepted as the source's own label CHEMBL3707222
Known as SAR-548304 ChEMBL registry synonym — accepted as the source's own label CHEMBL3707222
Known as SAR-548304 FREE ACID ChEMBL registry synonym — accepted as the source's own label CHEMBL3707222
Known as SHP626 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02787304
1

NCT02571192

Known as Volixibat (SHP626) Volixibat (SHP626)NCT02787304
Known as VOLIXIBAT POTASSIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL3707222
Action Inhibit “Ileal bile acid transporter inhibitor” CHEMBL3707222
1

“Volixibat inhibits bile acid reuptake” PMID 29548345 Mar 2018

Modality Small molecule CHEMBL3707222
Route Oral “Multiple Oral Doses of SHP626” NCT02287779
Target SLC10A2 “Ileal bile acid transporter inhibitor” CHEMBL3707222