Ravicti
Ravicti ingredients
| Active ingredient | Strength |
|---|---|
| Glycerol Phenylbutyrate | 1.1 g/mL |
What Ravicti is used for
The FDA lists the approved uses on the official label (below). In the EU, glycerol phenylbutyrate is approved as Ravicti for:
Ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Ravicti
- Generic name
- Glycerol phenylbutyrate
- Made by
- Horizon Therapeutics USA, Inc.
- Forms
- Liquid
- Given
- Oral
- Drug class
- Nitrogen Binding Agent
- FDA approval
- New drug application (NDA) NDA203284
- On the US market since
- 2013
Official information
- Ravicti prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Glycerol phenylbutyrate)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Ravicti?
Ravicti (Glycerol phenylbutyrate) is a specialist medicine made by Horizon Therapeutics USA, Inc., approved by the US FDA.
What are the ingredients of Ravicti?
Ravicti contains Glycerol Phenylbutyrate (1.1 g/mL).
Is Ravicti approved in Europe?
The same active substance is approved in the EU as Ravicti.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA