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 clinical pharmacology sodium phenylbutyrate is a pro-drug and is rapidly metabolized to phenylacetate. Approved for all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life), late-onset disease (partial enzymatic deficiency and 1 more indications. First approved in 2011.

Drug data last refreshed 21h ago

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Mechanism of Action

CLINICAL PHARMACOLOGY Sodium phenylbutyrate is a pro-drug and is rapidly metabolized to phenylacetate. Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine. Phenylacetylglutamine then is excreted by the kidneys. On a molar…

Indications (4)

all patients with neonatal-onset deficiency (complete enzymatic deficiency presenting within the first 28 days of life)

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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