AMANTADINE · ZYDUS
Development Insights
Details
- Status
- None (Tentative Approval)
- First Approved
- 2024-08-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
AMANTADINE Approval History
What AMANTADINE Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 2024)Letter
Clinical Trial Registry
13 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| NCT06234462 | STU-2023-0234 | Ph 2 | withdrawn | A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid |
| 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 |
| 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.
AMANTADINE FDA Label Details
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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