HORIZANT (gabapentin enacarbil)
Horizant (gabapentin enacarbil) is
How HORIZANT Works
This drug works by acting as a prodrug that converts into gabapentin once inside the body. While its exact process for relieving symptoms is not fully understood, it binds strongly to the α2δ subunit of voltage-activated calcium channels. In animal studies, this activity helps prevent exaggerated responses to pain and pain caused by normally harmless stimuli.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-04-06
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
HORIZANT Approval History
What HORIZANT Treats
2 indicationsHORIZANT is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Restless Legs Syndrome
- Postherpetic Neuralgia
HORIZANT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to HORIZANT
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03053427 results posted | 8825-CL-0101 | Ph 4 | completed | A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients |
| NCT01981941 | 8825-CL-0103 | Ph 4 | completed | Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment |
| NCT03082755 | 2016-09-0152 R01AG051588-02 | Ph 4 | recruiting | Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease |
| NCT02252536 results posted | NCIG - 006 | Ph 2 | completed | HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder |
| NCT01411124 | 114111 | Ph 1 | completed | Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects |
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.
HORIZANT FDA Label Details
Indications & Usage
FDA Label (PDF)HORIZANT is indicated for the treatment of Restless Legs Syndrome; Postherpetic Neuralgia.
Pro Intelligence Preview
Deep insights for HORIZANT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 16 active patents
Trial Analysis
- • 5 total trials
- • Stage: Mature
Competitive Landscape
- • 6 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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