SODIUM PHENYLACETATE AND SODIUM BENZOATE (sodium benzoate)
Sodium phenylacetate and sodium benzoate is a nitrogen-binding agent indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in pediatric and adult patients with urea cycle disorders (UCDs). It is used during acute metabolic crises alongside dietary protein restriction, arginine supplementation, and other ammonia-lowering modalities such as hemodialysis. The medication provides a critical alternative vehicle for nitrogen excretion when the primary urea cycle enzymes are deficient.
How SODIUM PHENYLACETATE AND SODIUM BENZOATE Works
This medication functions by creating alternative metabolic pathways for the excretion of waste nitrogen. Phenylacetate conjugates with glutamine to form phenylacetylglutamine (removing two moles of nitrogen per mole of phenylacetate), while benzoate conjugates with glycine to form hippuric acid (removing one mole of nitrogen per mole of benzoate). These resulting compounds are rapidly excreted by the kidneys via glomerular filtration and tubular secretion, effectively bypassing the defective urea cycle to reduce toxic ammonia levels.
Details
- Status
- Prescription
- First Approved
- 2016-02-24
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
Companies
SODIUM PHENYLACETATE AND SODIUM BENZOATE Approval History
What SODIUM PHENYLACETATE AND SODIUM BENZOATE Treats
3 indicationsSODIUM PHENYLACETATE AND SODIUM BENZOATE is approved for 3 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperammonemia
- Encephalopathy
- Urea Cycle Disorder
SODIUM PHENYLACETATE AND SODIUM BENZOATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03510741 | PILL-Sodium Benzoate & NAC-001 | Ph 2 | completed | Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder. |
| NCT02026947 AttenPsyc | 3418363 2013-000458-23 | Ph 2 | withdrawn | Sodium Benzoate for Treatment of Attenuated/Transient Psychosis. A Randomized Placebo-controlled Trial. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SODIUM PHENYLACETATE AND SODIUM BENZOATE FDA Label Details
Indications & Usage
FDA Label (PDF)SODIUM PHENYLACETATE AND SODIUM BENZOATE is indicated for the treatment of Hyperammonemia; Encephalopathy; Urea Cycle Disorder.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.