ZANAFLEX (tizanidine hydrochloride)
Zanaflex helps patients with spasticity manage their symptoms during specific times of the day. Because its effects don't last very long, it is typically used when relief is most necessary for a person's daily activities. This medication provides a targeted approach for those needing temporary reduction in spasticity.
How ZANAFLEX Works
This drug works by acting as a central alpha-2-adrenergic receptor agonist to increase the inhibition of motor neurons before they send signals. It primarily affects polysynaptic pathways, which results in less stimulation of the spinal motor neurons. This process ultimately leads to a reduction in muscle spasticity.
Details
- Status
- Prescription
- First Approved
- 1996-11-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
ZANAFLEX Approval History
What ZANAFLEX Treats
1 indicationsZANAFLEX is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Spasticity
ZANAFLEX 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 ZANAFLEX
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05484349 | 2022-0622 | Ph 3 | recruiting | TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME） |
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.
ZANAFLEX FDA Label Details
Indications & Usage
FDA Label (PDF)ZANAFLEX is indicated for the treatment of Spasticity.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.