GOCOVRI (amantadine hydrochloride)
GOCOVRI is indicated for the treatment of Dyskinesia; Parkinson's Disease.
How GOCOVRI Works
The exact mechanism of amantadine in treating Parkinson’s disease symptoms is unknown. It is a weak uncompetitive NMDA receptor antagonist and may exert direct or indirect effects on dopamine neurons. While animal studies show no direct anticholinergic activity, amantadine exhibits anticholinergic-like side effects (e.g., dry mouth, urinary retention) and dopaminergic-like side effects (e.g., hallucinations, dizziness) in humans.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-08-24
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
GOCOVRI Approval History
What GOCOVRI Treats
2 indicationsGOCOVRI is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dyskinesia
- Parkinson's Disease
GOCOVRI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 GOCOVRI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01538329 PREMANDYSK | 11 253 01 2011-005201-75 | Ph 2 | completed | Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease |
| NCT05140148 PRESTA | 849451 | Ph 2 | recruiting | Promoting Recovery After STroke With Amantadine |
| NCT06055244 AmantadineLC | 2023H0268 GF317855 | Ph 2 | completed | Amantadine Therapy for Cognitive Impairment in Long COVID |
| NCT06234462 | STU-2023-0234 | Ph 2 | withdrawn | A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid |
| NCT06253923 | MR-301-T-001 | Ph 2 | active not recruiting | Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI). |
| NCT04387773 results posted | 20105 | Ph 4 | completed | Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease |
| NCT03430817 | FMASU R44/2017 | Ph 4 | completed | Citicholine-Amantadine Trial in Traumatic Brain Injury |
| NCT01071395 results posted | Valid Dyskin Rating Scales | Ph 4 | completed | Validation of Dyskinesia Rating Scales |
| NCT04952519 TITAN | 00980.045 2021-000981-13 | Ph 3 | terminated | Efficacy of Amantadine Treatment in COVID-19 Patients |
| NCT04273737 results posted | AAAS1907 | Ph 4 | terminated | Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy |
| NCT03185065 TRIUMPHANT-MS results posted | IRB00119702 | Ph 3 | completed | Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis |
| NCT02486211 AWAKE results posted | 15GRNT25680021 | Ph 2 | completed | Amantadine to Speed Awakening After Cardiac Arrest |
| NCT01652534 results posted | M012010 | Ph 3 | terminated | Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease |
| NCT01789047 TOP-DYSK results posted | TOP-DYSK | Ph 2 | terminated | Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease |
| NCT01441986 DXM/AMT | 0533-DXM | Ph 2 | completed | Dextromethorphan, Amantadine and Glucose Homeostasis in Diabetes Subjects |
| NCT00600093 | 4332 | Ph 2 | terminated | Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine |
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.
GOCOVRI FDA Label Details
Indications & Usage
FDA Label (PDF)GOCOVRI is indicated for the treatment of Dyskinesia; Parkinson's Disease.
GOCOVRI Patents & Exclusivity
Patents (13 active)
Pro Intelligence Preview
Deep insights for GOCOVRI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 68 active patents
Trial Analysis
- • 13 total trials
- • Stage: Declining
Competitive Landscape
- • 20 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