NDAORALFOR SUSPENSION
Approved
Dec 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
5/8 — Partial
OLPRUVA (sodium phenylbutyrate) by Medunik is clinical pharmacology sodium phenylbutyrate is a pro-drug and is rapidly metabolized to phenylacetate. Approved for hyperammonemia, medium-chain acyl-coa dehydrogenase deficiency, combined d,l-2-hydroxyglutaric aciduria. First approved in 2022.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OLPRUVA is a sodium phenylbutyrate oral suspension approved in December 2022 for hyperammonemia and rare metabolic disorders including Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Combined D,L-2-Hydroxyglutaric Aciduria. It is a pro-drug that metabolizes to phenylacetate, which conjugates with glutamine to form phenylacetylglutamine for renal excretion, providing an alternate pathway for waste nitrogen removal. The mechanism enables management of elevated ammonia levels in patients with urea cycle disorders and other metabolic conditions.
Peak10.5 years to LOE
Early-stage product in peak commercial phase with limited competitive pressure, suggesting opportunity for market expansion and team growth in rare disease specialization.
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 (3)
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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.