PHEBURANE

Peak

sodium phenylbutyrate

NDAORALPELLETS
Approved
Jun 2022
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4

Mechanism of Action

pro-drug and is metabolized to phenylacetate. Phenylacetate is a metabolically-active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine. Phenylacetylglutamine is excreted by the kidneys, hence providing an alternate vehicle for waste nitrogen excretion.

Clinical Trials (4)

NCT06773026Phase 2Recruiting

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
NCT05349435Phase 1Terminated

A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate

Started May 2022
NCT03335488Phase 4Completed

Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)

Started Feb 2018
16 enrolled
Urea Cycle Disorder
NCT00947544Phase 2Completed

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