SODIUM PHENYLBUTYRATE

Post-LOE

Alvogen

ANDAORALTABLET

Approved

Nov 2011

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

SODIUM PHENYLBUTYRATE by Alvogen is pro-drug and is metabolized to phenylacetate. Approved for acute hyperammonemia, which can be a life-threatening medical emergency. First approved in 2011.

Drug data last refreshed 19h ago

$0.0BPart D

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.

Indications (2)

acute hyperammonemia which can be a life-threatening medical emergency

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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.

Clinical Trials (5)

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

8 enrolled

Hyperammonemia

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

NCT00528268Phase 1/2Completed

Study to Evaluate Sodium Phenylbutyrate in Pre-symptomatic Infants With Spinal Muscular Atrophy

Started Jul 2007

22 enrolled

Spinal Muscular Atrophy