3 completed, 2 active not recruiting, 2 terminated. 4 Phase 2, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Active not recruiting 2, Terminated 2 |
| Phase 1 | 3 | Completed 3 |
Follow volixibat: new trials by email Literature Review of volixibat trials Research Report on volixibat
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Volixibat, Placebo - Primary Biliary Cholangitis, PBC | Phase 2 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 333 | 2021-09-22 | 2026-08-25 |
| A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA) Volixibat, Placebo - Intrahepatic Cholestasis of Pregnancy | Phase 2 | Terminated | Mirum Pharmaceuticals, Inc. | 4 | 2021-01-04 | 2024-08-06 |
| A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) Volixibat, Placebo - Primary Sclerosing Cholangitis | Phase 2 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 182 | 2020-12-18 | 2026-10-19 |
| Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) SHP626, Placebo - Non-Alcoholic Steatohepatitis | Phase 2 | Terminated | Mirum Pharmaceuticals, Inc. | 197 | 2016-10-24 | 2019-11-25 |
| A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose SHP626, 5.95 μCi RAD - Non-Alcoholic Steatohepatitis | Phase 1 | Completed | Mirum Pharmaceuticals, Inc. | 8 | 2015-10-01 | 2019-05-01 |
| Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion Placebo, Maralixibat, Volixibat - Healthy Volunteers | Phase 1 | Completed | Mirum Pharmaceuticals, Inc. | 84 | 2015-06-01 | 2019-04-04 |
| Safety and Tolerability Study of SHP626 in Overweight and Obese Adults SHP626, Placebo - Non-Alcoholic Steatohepatitis | Phase 1 | Completed | Mirum Pharmaceuticals, Inc. | 84 | 2015-01-19 | 2019-03-26 |
Non-alcoholic Fatty Liver Disease (3) · Pruritus (3) · Cholestasis (2) · Cholangitis (1) · Cholangitis, Sclerosing (1) · Digestive System Diseases (1) · Fatty Liver (1) · Intrahepatic Cholestasis of Pregnancy (1) · Liver Cirrhosis, Biliary (1) · Liver Diseases (1)
Mirum Pharmaceuticals, Inc. (7)
United States (7) · United Kingdom (4) · Canada (3) · Argentina (2) · Belgium (2) · Brazil (2) · France (2) · Germany (2) · Israel (2) · Italy (2) · Netherlands (2) · Spain (2) · Switzerland (2) · Australia (1) · China (1)
PMID 28702877, PMID 29548345, PMID 32234329, PMID 40439725, PMID 41603551
2016 (1), 2023 (1)