NDAORALFOR SUSPENSION
Approved
Dec 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
4/8 — Partial
OLPRUVA (sodium phenylbutyrate) by Medunik is clinical pharmacology sodium phenylbutyrate is a pro-drug and is rapidly metabolized to phenylacetate. First approved in 2022.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OLPRUVA (sodium phenylbutyrate) is an oral suspension small molecule approved in December 2022 for urea cycle disorders. It is a pro-drug that metabolizes to phenylacetate, which conjugates with glutamine to form phenylacetylglutamine, providing an alternative pathway for waste nitrogen excretion comparable to urea on a molar basis. The mechanism leverages the kidneys to eliminate excess nitrogen without ammonia accumulation.
Peak10.3 years to LOE
Recently approved product in peak commercial phase with no direct competitors, suggesting active market expansion and team growth opportunities.
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
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
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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.