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?

An Open Label Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate (GPB; RAVICTI) in Pediatric Subjects Under Two Years of Age With Urea Cycle Disorders (UCDs)

Trial Profile

An Open Label Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate (GPB; RAVICTI) in Pediatric Subjects Under Two Years of Age With Urea Cycle Disorders (UCDs)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 07 Mar 2019

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 Glycerol phenylbutyrate (Primary)
  • Indications Inborn urea cycle disorders
  • Focus Therapeutic Use
  • Sponsors Horizon Pharma
  • Most Recent Events

    • 30 Jan 2019 The European Commission has approved RAVICTI (glycerol phenylbutyrate) for patients from birth to two months suffering from a urea cycle disorder following a positive CHMP opinion from the European Medicines Agency (EMA), based on the data from this study.
    • 27 Dec 2018 According to a Horizon Pharma media release, the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for RAVICTI (glycerol phenylbutyrate) Oral Liquid to include infants younger than two months of age living with a urea cycle disorder (UCD).
    • 31 Aug 2018 Biomarkers information updated
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top