Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Volixibat - Mirum Pharmaceuticals

Next Previous
Drug Profile

Volixibat - Mirum Pharmaceuticals

Alternative Names: LUM-002; SAR-548304; SHP-626; Volixibat - Takeda; Volixibat potassium

Latest Information Update: 05 Jun 2026

Price :
$50 *
Note:
  • Adis is an information provider. We do not sell or distribute actual drugs.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.
  • A link to download a PDF version of the drug profile will be included in your email receipt.

At a glance

  • Originator sanofi-aventis
  • Developer Mirum Pharmaceuticals; Sanofi; Shire
  • Class Anti-inflammatories; Antihyperlipidaemics; Benzothiepins; Hepatoprotectants; Small molecules; Urea compounds
  • Mechanism of Action Sodium-bile acid cotransporter inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Primary biliary cirrhosis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Primary biliary cirrhosis
  • Phase II Intrahepatic cholestasis; Primary sclerosing cholangitis
  • No development reported Cholestasis
  • Discontinued Hypercholesterolaemia; Non-alcoholic steatohepatitis

Most Recent Events

  • 30 May 2026 Mirum plans a NDA submission of Volixibat in Primary sclerosing cholangitis in 2H of 2026
  • 30 May 2026 Mirum plans a pre-NDA meeting with US FDA regarding NDA submission of Volixibat in Primary sclerosing cholangitis in Summer 2026
  • 30 May 2026 Efficacy and adverse events data from a phase II trial in Primary sclerosing cholangitis released by Mirum Pharmaceuticals

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top