NDAORALLIQUID
Approved
Feb 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
4/8 — Partial
Drug data last refreshed 1h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RAVICTI is an oral liquid formulation of glycerol phenylbutyrate, a nitrogen scavenger indicated for chronic management of hyperammonemia in patients with urea cycle disorders. It works by providing an alternative pathway for nitrogen excretion, reducing ammonia levels in the blood. This small-molecule therapeutic is designed for long-term maintenance therapy in a rare, life-threatening metabolic condition.
$0.073BPart D
PeakStable
4.0 years to LOEThe product is at peak commercial maturity with stable Part D spending of $73M annually across 810 claims, indicating a mature, concentrated patient base typical of rare disease franchises.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)
Started Feb 2018
16 enrolled
Urea Cycle Disorder
A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
Started Dec 2014
27 enrolled
Urea Cycle Disorder
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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.