NDAORALFOR SOLUTIONPriority Review
Approved
Aug 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SABRIL (vigabatrin) is an oral anti-epileptic agent approved in 2009 for treating specific seizure disorders. It is a small-molecule inhibitor of GABA catabolism that increases inhibitory neurotransmitter availability in the central nervous system. The drug is indicated for management of refractory seizures and infantile spasms.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30), suggesting the brand team is likely focused on lifecycle extension and market share defense rather than growth initiatives.
Mechanism of Action
Pharmacologic Class:
Anti-epileptic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
Started Jun 2012
0Infantile Spasms
Vigabatrin for the Treatment of Cocaine Dependency
Started Jan 2011
207 enrolled
Cocaine AddictionCocaine Dependence
A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
Started Dec 2010
65 enrolled
Adult Refractory Complex Partial Seizures
Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
Started Aug 2010
1 enrolled
Complex Partial Seizures
Sabril Patient Registry
Started Aug 2009
9,423 enrolled
Infantile SpasmsRefractory Complex Partial Seizures in Adults
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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.