Regulatory PathRegulatory requirements compared

Active substance

Glycerol phenylbutyrate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Glyicti1.1 g/mlOral liquid · Oral use1 BottleSAR 1198.55Generic · PrescriptionSaudi AmaroxValid
Ravicti1.1 g/mlOral liquid · Oral use1 BottleSAR 1198.55NCE · PrescriptionImmedica Pharma ABValid

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
RAVICTI1.1GM/MLliquid · oralHORIZON THERAP USPrescription1 Feb 2013
GLYCEROL PHENYLBUTYRATE1.1GM/MLliquid · oralPH HEALTHPrescription2 Dec 2021
GLYCEROL PHENYLBUTYRATE1.1GM/MLliquid · oralTEVA PHARMS INCPrescription15 Apr 2026
GLYCEROL PHENYLBUTYRATE1.1GM/MLliquid · oralMSNPrescription15 Apr 2026
GLYCEROL PHENYLBUTYRATE1.1GM/MLliquid · oralAUROBINDO PHARMAPrescription15 Apr 2026
GLYCEROL PHENYLBUTYRATE1.1GM/MLliquid · oralNAVINTA LLCPrescription23 Apr 2026
GLYCEROL PHENYLBUTYRATE1.1GM/MLliquid · oralLUPINPrescription30 Apr 2026
GLYCEROL PHENYLBUTYRATE1.1GM/MLliquid · oralPAI HOLDINGSPrescription28 Jul 2026

EMA European Union — centrally authorised medicines

Ravicti Immedica Pharma AB · Authorised · authorised 26 Nov 2015 · ATC A16AX09

Therapeutic indication (EMA)

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).

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
RAVICTI024533041.1 G / MLLIQUID · ORALHORIZON THERAPEUTICS IRELAND DAC

Safety signals and safety-related labeling changes

  • US FDA 3 Sep 2021 RAVICTI — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for glycerol phenylbutyrate →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.