Drugs / Volixibat
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| 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 23 trials · 1 met primary | ||||||
| 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 Stop: Enrollment |
| Phase 2 | NCT04663308 | Dec 2020 → Jun 2026 overdue | primary sclerosing cholangitis | Mirum Pharmaceuticals, Inc. | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-05-30 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals Announces New Data from Rare Liver Disease Programs Presented at the EASL International Liver Congress 2026 mirumpharma.com ↗
Late-breaking VISTAS results demonstrate rapid, sustained, and clinically meaningful reductions in pruritus with volixibat in primary sclerosing cholangitis (PSC) |
| 2026-05-21 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals to Present Data Showcasing Leadership in Rare Liver Diseases at the EASL International Liver Congress 2026 mirumpharma.com ↗
Late-breaking VISTAS results demonstrate rapid, sustained, and clinically meaningful reductions in pruritus with volixibat in primary sclerosing cholangitis (PSC) |
| 2026-05-04 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals Announces Primary Endpoint Met in VISTAS Study of Volixibat in Patients with Primary Sclerosing Cholangitis mirumpharma.com ↗ |
| 2025-11-07 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals Showcases Leadership in Liver Disease Innovation With Data From LIVMARLI® and Volixibat Clinical Programs at AASLD’s The Liver Meeting® mirumpharma.com ↗
Volixibat Leads to Improvements in Fatigue and Sleep for Adults with Primary Biliary Cholangitis: Data from VANTAGE Trial |
| 2025-05-09 | Mirum Pharmaceuticals, Inc. | Results Volixibat Data from Mirum’s VANTAGE PBC Study Showcased at EASL mirumpharma.com ↗
Volixibat treatment led to rapid (as early as week 1) and sustained reductions in ItchRO with the volixibat combined dose group achieving a statistically significant 3.78-point reduction from Baseline (p<0.0001) and a placebo-adjusted response of 2.51 (p=0.0004). |
| 2025-04-28 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals to Present Data at Upcoming Medical Congresses mirumpharma.com ↗
We are encouraged by the positive results which show a meaningful decrease in pruritus that lasts for the duration of the placebo-controlled period. |
| 2024-10-10 | Mirum Pharmaceuticals, Inc. | Regulatory Volixibat Granted Breakthrough Therapy Designation for Cholestatic Pruritus in Primary Biliary Cholangitis mirumpharma.com ↗
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to volixibat as a potential treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC). |
| 2024-06-17 | Mirum Pharmaceuticals, Inc. | Results Mirum’s Volixibat Achieves Positive Interim Analyses in VANTAGE PBC and VISTAS PSC Studies mirumpharma.com ↗
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced interim results from two Phase 2b studies evaluating volixibat, an oral ileal bile acid transporter (IBAT) inhibitor in patients with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). |
| 2023-11-13 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals Presents New Data at The Liver Meeting® mirumpharma.com ↗
Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced new data from its LIVMARLI and volixibat programs presented at The Liver Meeting®, the American Association for the Study of Liver Diseases (AASLD) annual meeting in Boston, Massachusetts. |
| 2022-11-29 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals Provides Development Program Updates mirumpharma.com ↗
In an interim analysis, patients treated with volixibat saw meaningful reductions in serum bile acids and pruritus. |
| 2022-06-24 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals Presents New Data at The International Liver Congress™ of the European Association for the Study of the Liver (EASL) mirumpharma.com ↗
The data demonstrated that: There were 0% GI-related adverse events in the fasted state in two out of the three fasted studies. |
| 2020-11-13 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals Presents New Data From Its Maralixibat and Volixibat Clinical Studies at AASLD Annual Meeting mirumpharma.com ↗
Volixibat data shows highly active dose levels selected for Phase 2 studies. |
| 2016-07-29 | Takeda | Regulatory 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 ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. |
| 2014-12-10 | Takeda | Regulatory Shire R&D Day Profiles Innovative Pipeline Expected To Contribute $3 Billion In Product Sales By 2020 takeda.com ↗
An IND for SHP626 in patients with Non-Alcoholic Steatohepatitis (NASH) has been submitted in November and following FDA permission to proceed we plan to initiate a Phase 1b multiple-dose study in Q1 2015. |
All press releases naming this drug 18 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited 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 |
| Action | Inhibit | “Volixibat inhibits bile acid reuptake” PMID 29548345 ↗ Mar 2018 |
| Route | Oral | “Multiple Oral Doses of SHP626” NCT02287779 ↗ |