VIGAFYDE (vigabatrin)
VIGAFYDE is an anti-epileptic medication used for infants and young children between 1 month and 2 years of age who have infantile spasms. It serves as a single-drug therapy in cases where the clinical benefits are determined to outweigh the potential risk of vision loss. This medication helps patients in this specific age group manage their seizure activity.
How VIGAFYDE Works
This medication works by permanently blocking GABA-transaminase, the enzyme responsible for breaking down the inhibitory neurotransmitter GABA. By inhibiting this process, the drug increases GABA levels within the central nervous system to produce its anti-seizure effects. The duration of this effect depends on how quickly the body can create new enzymes rather than how long the drug remains in the bloodstream.
Details
- Status
- Prescription
- First Approved
- 2024-06-17
- Patent Cliff
- 2043
- Routes
- ORAL
- Dosage Forms
- SOLUTION
VIGAFYDE Approval History
What VIGAFYDE Treats
1 indicationsVIGAFYDE is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Infantile Spasms
VIGAFYDE Boxed Warning
PERMANENT VISION LOSS VIGAFYDE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGAFYDE also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )]. The onset of vision loss from VIGAFYDE is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years. Symptoms of vision loss from V...
WARNING: PERMANENT VISION LOSS VIGAFYDE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGAFYDE also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )]. The onset of vision loss from VIGAFYDE is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years. Symptoms of vision loss from VIGAFYDE are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function. The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss. Vision assessment is recommended at baseline (no later than 4 weeks after starting VIGAFYDE), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy. Once detected, vision loss due to VIGAFYDE is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss. Consider drug discontinuation, balancing benefit and risk, if vision loss is documented. Risk of new or worsening vision loss continues as long as VIGAFYDE is used. It is possible that vision loss can worsen despite discontinuation of VIGAFYDE. Because of the risk of vision loss, VIGAFYDE should be withdrawn from patients with infantile spasms who fail to show substantial clinical benefit within 2 to 4 weeks of initiation, or sooner if treatment failure becomes obvious. Patient response to and continued need for VIGAFYDE should be periodically reassessed. VIGAFYDE should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks. VIGAFYDE should not be used with o
VIGAFYDE Competitive Set
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Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04321395 results posted | 202006177 | Ph 2 | completed | Vigabatrin and Insulin Sensitivity |
| NCT03421496 results posted | INS011-16-082 | Ph 3 | terminated | A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms |
| NCT03347526 | 17-0222 | Ph 3 | suspended | A Novel Approach to Infantile Spasms |
| NCT02299115 PREDVGB | 1000045463 | Ph 3 | withdrawn | Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms |
| NCT01335867 VGB results posted | 812864 P50DA012756 | Ph 2 | terminated | Vigabatrin for Cocaine and Alcohol Dependence |
| NCT01585207 results posted | GCO 12-0964 11-01864 | Ph 1, Ph 2 | completed | Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette's Disorder |
| NCT01266291 STARS results posted | 811542 | Ph 4 | terminated | Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients |
| NCT00626834 | OV-1014 | Ph 1 | completed | Vigabatrin Ph 1 Cocaine Interaction Study |
| NCT01281202 results posted | CPP-01005/CS# 1030 TRANSFERRED Y1-DA4006 | Ph 2, Ph 3 | completed | Vigabatrin for the Treatment of Cocaine Dependency |
| NCT00611130 results posted | CPP-01004 | Ph 2 | completed | Vigabatrin for Treatment of Cocaine Dependence |
| NCT01413711 | 13453A | Ph 4 | withdrawn | An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VIGAFYDE FDA Label Details
Indications & Usage
FDA Label (PDF)VIGAFYDE is indicated for the treatment of Infantile Spasms.
WARNING: PERMANENT VISION LOSS VIGAFYDE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGAFYDE also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )]. The ons...
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Revenue Insights
- • Quarterly revenue tracking
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Patent Timeline
- • Cliff: 2043
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.