AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE is indicated for the treatment of Influenza A; Parkinsonism.
How AMANTADINE HYDROCHLORIDE Works
The mechanism of action of amantadine hydrochloride involves two distinct pathways: 1. **Antiviral Activity:** Amantadine inhibits the viral M2 protein ion channel of the influenza A virus. This prevents the acidification of the viral interior, which is a necessary step for viral uncoating and the subsequent release of viral RNA into the host cell. 2. **Antiparkinsonian Activity:** The exact mechanism is not fully established but is believed to involve weak, non-competitive NMDA (N-methyl-D-aspartate) receptor antagonism. This action reduces the overstimulation of glutamatergic neurons. Additionally, amantadine has been shown to facilitate the release of dopamine from presynaptic terminals and may inhibit dopamine reuptake.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1987-01-07
- Routes
- ORAL
- Dosage Forms
- CAPSULE, SYRUP, TABLET, CAPSULE, EXTENDED RELEASE
Companies
AMANTADINE HYDROCHLORIDE Approval History
What AMANTADINE HYDROCHLORIDE Treats
2 indicationsAMANTADINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Influenza A
- Parkinsonism
AMANTADINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 AMANTADINE HYDROCHLORIDE
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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). |
| NCT04273737 results posted | AAAS1907 | Ph 4 | terminated | Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy |
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 HYDROCHLORIDE FDA Label Details
Indications & Usage
AMANTADINE HYDROCHLORIDE is indicated for the treatment of Influenza A; Parkinsonism.
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GOCOVRI
Full clinical data, patents, trials, and competitive landscape for amantadine hydrochloride.
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