NDAORALPELLETS
Approved
Jun 2022
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PHEBURANE (sodium phenylbutyrate) is an oral pellet formulation approved in June 2022 for the treatment of urea cycle disorders and related hyperammonemia conditions. It works by providing an alternative pathway for waste nitrogen excretion, reducing ammonia levels in patients who cannot process it through the normal urea cycle. The drug addresses a serious metabolic disorder affecting a small but critical patient population.
Peak
The product is in peak lifecycle stage with moderate competitive pressure (30), indicating an established commercial presence with stable team staffing and focused market penetration efforts.
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
Worked on PHEBURANE at Medunik? Share your interview experience or compensation data (+7 days Pro)
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.