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?

A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Trial Profile

A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 15 Feb 2024

Price : $35 *
  • Adis is an information provider.
  • 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 trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Seladelpar (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Pharmacodynamics; Proof of concept
  • Sponsors CymaBay Therapeutics; Vitaflo
  • Most Recent Events

    • 12 Feb 2024 According to a CymaBay Therapeutics media release, the FDA has granted priority review and set a Prescription Drug User Fee Act (PDUFA) target action date of August 14, 2024 and notified the company that it is not currently planning to hold an advisory committee meeting to discuss the application.
    • 12 Feb 2024 According to a CymaBay Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar for the management of primary biliary cholangitis including pruritus in adults without cirrhosis or with compensated cirrhosis who are inadequate responders or intolerant to ursodeoxycholic acid.The NDA includes data from across Phase 3 RESPONSE, ENHANCE and ASSURE study and prior Phase 2 studies.
    • 27 Jul 2020 This trial has been completed in United Kingdom, according to European Clinical Trials Database record.(Global end date: 2016-05-26)
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top