NDAORALPELLETS
Approved
Jun 2022
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PHEBURANE (sodium phenylbutyrate) is an oral pellet formulation approved by the FDA in June 2022 for the management of urea cycle disorders (UCDs), rare genetic conditions affecting ammonia metabolism. The drug works by providing an alternative pathway for nitrogen excretion, reducing toxic ammonia levels in patients who cannot metabolize it through the normal urea cycle. It is indicated for chronic management of UCDs in pediatric and adult patients.
Peak
Product is in peak commercial phase with moderate competitive pressure (30%), suggesting active sales force deployment and brand differentiation efforts across specialty and metabolic disease channels.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Study of Sodium Phenylbutyrate (ACER-001) for the Treatment of Pediatric and Adults Patients With Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD)
Started Jun 2025
24 enrolled
Medium-chain Acyl-CoA Dehydrogenase Deficiency
A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate
Started May 2022
8 enrolled
Hyperammonemia
Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)
Started Feb 2018
16 enrolled
Urea Cycle Disorder
Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children With Urea Cycle Disorders
Started Mar 2010
17 enrolled
Urea Cycle Disorders
Study to Evaluate Sodium Phenylbutyrate in Pre-symptomatic Infants With Spinal Muscular Atrophy
Started Jul 2007
22 enrolled
Spinal Muscular Atrophy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.