NDAORALFOR SUSPENSIONPriority Review
Approved
Sep 2022
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
Priority Review
RELYVRIO (sodium phenylbutyrate; taurursodiol) by Amylyx Pharmaceuticals 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 2022.
Drug data last refreshed 28m ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RELYVRIO is an oral suspension combining sodium phenylbutyrate and taurursodiol for treating urea cycle disorders (UCDs) in both neonatal-onset (complete enzymatic deficiency within 28 days of life) and late-onset disease (partial deficiency after one month). Sodium phenylbutyrate metabolizes to phenylacetate, which conjugates with glutamine to form phenylacetylglutamine—an alternate waste nitrogen excretion pathway that functions similarly to urea on a molar basis.
$198MPart D
Peak14.0 years to LOEProduct is in peak commercial phase with established Medicare utilization (~16K claims in 2023), supporting growing teams across commercial, supply chain, and communications functions.
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…
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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.