VIGADRONE (vigabatrin)
VIGADRONE is indicated for the treatment of Complex Partial Seizures; Infantile Spasms.
How VIGADRONE Works
Vigadrone acts as an irreversible inhibitor of gamma-aminobutyric acid transaminase (GABA-T), the enzyme responsible for metabolizing the inhibitory neurotransmitter GABA. By blocking this enzyme, the drug increases the levels of GABA within the central nervous system. The duration of the drug's effect is determined by the rate of enzyme re-synthesis rather than the rate at which the drug is eliminated from systemic circulation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-06-21
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
VIGADRONE Approval History
What VIGADRONE Treats
2 indicationsVIGADRONE is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Complex Partial Seizures
- Infantile Spasms
VIGADRONE Boxed Warning
PERMANENT VISION LOSS VIGADRONE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGADRONE also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )]. The onset of vision loss from VIGADRONE 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...
WARNING: PERMANENT VISION LOSS VIGADRONE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGADRONE also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )]. The onset of vision loss from VIGADRONE 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 VIGADRONE 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 VIGADRONE), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy. Once detected, vision loss due to VIGADRONE 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 VIGADRONE is used. It is possible that vision loss can worsen despite discontinuation of VIGADRONE. Because of the risk of vision loss, VIGADRONE should be withdrawn from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation and within 2 to 4 weeks of initiation for patients with infantile spasms, or sooner if treatment failure becomes obvious. Patient response to and continued need for VIGADRONE should be periodically reassessed. VIGADRONE should not be used in patients with, or at high risk of, other types of irreversible vision lo
VIGADRONE Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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.
VIGADRONE FDA Label Details
Indications & Usage
VIGADRONE is indicated for the treatment of Complex Partial Seizures; Infantile Spasms.
WARNING: PERMANENT VISION LOSS VIGADRONE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGADRONE also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )]. The o...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment