SYMMETREL (amantadine hydrochloride) · ENDO PHARMS
SYMMETREL is FDA-approved to treat 2 conditions (same as AMANTADINE HYDROCHLORIDE).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1968-02-14
- Routes
- ORAL
- Dosage Forms
- CAPSULE, SYRUP, TABLET
SYMMETREL Approval History
What SYMMETREL Treats
2 indicationsSYMMETREL is approved for 2 conditions since its original approval in 1968. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Influenza A
- Parkinsonism
Same approved indications as AMANTADINE HYDROCHLORIDE (same active ingredient).
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.
SYMMETREL FDA Label Details
Indications & Usage
FDA Label (PDF)SYMMETREL is FDA-approved to treat 2 conditions — same approved indications as AMANTADINE HYDROCHLORIDE.
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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