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 13h 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 the treatment of urea cycle disorders in neonatal-onset and late-onset presentations. Sodium phenylbutyrate acts as a pro-drug that conjugates with glutamine to form phenylacetylglutamine, providing an alternate pathway for nitrogen waste excretion comparable to urea. The combination formulation targets both ammonia reduction and hepatoprotection in patients with enzymatic deficiency presenting within the first 28 days of life or after one month of life.
$198MPart D
Peak13.7 years to LOEPeak lifecycle with $198M Part D spending in 2023 indicates an established brand with mature commercial infrastructure and team expansion potential in commercial and medical affairs 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.