TheraRadar
Data updated: May 26, 2026

SYMMETREL (amantadine hydrochloride)

Trial Activity: Declining 1 active trials
CNS Approved 1968-02-14
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Rush University Medical Center conducting 2 trials (15%)
18 indications explored (Broad Platform)
→ parkinson disease (2 trials)
→ long covid (2 trials)
→ parkinson's disease (2 trials)
5
Indications
--
Phase 3 Trials
3
Priority Reviews
58
Years on Market

Details

Status
Discontinued
First Approved
1968-02-14
Routes
ORAL
Dosage Forms
CAPSULE, TABLET, SYRUP

Companies

ENDO PHARMS
Active Ingredient: AMANTADINE HYDROCHLORIDE

SYMMETREL Approval History

1969
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Original
New Indication
New Form
Label Update
41 FDA actions from 1968 to 2009 · 2 indication expansions
Feb 2009 SUPPL
Label · Labeling
FDA Letter Label
Dec 2008 SUPPL Priority
Label · Labeling
FDA Letter Label
Sep 2008 SUPPL
Label · Labeling
FDA Letter Label

What SYMMETREL Treats

5 FDA approvals

Originally approved for its first indication in 1968 . Covers 5 distinct patient populations.

  • Other (5)
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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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

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Data Sources

FDA Approval: NDA016020 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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