NDAORALTABLET
Approved
Nov 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
ZANAFLEX (tizanidine hydrochloride) by Enterprise Therapeutics is alpha-2-adrenergic receptor agonist and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. Approved for spasticity in adults. First approved in 1996.
Drug data last refreshed 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZANAFLEX (tizanidine hydrochloride) is an oral small-molecule alpha-2-adrenergic receptor agonist approved in 1996 for treating spasticity in adults. It works by increasing presynaptic inhibition of motor neurons, with greatest effects on polysynaptic pathways, thereby reducing spinal motor neuron facilitation.
$0.5MPart D
LOE ApproachingProduct nearing loss of exclusivity with declining market activity; limited team expansion expected.
Mechanism of Action
alpha-2-adrenergic receptor agonist and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. The effects of tizanidine are greatest on polysynaptic pathways. The overall effect of these actions is thought to reduce facilitation of spinal motor neurons.
Indications (1)
Clinical Trials (1)
BOTOX® Versus Zanaflex® for the Treatment of Post-Stroke or Traumatic Brain Injury Upper Limb Spasticity
Started Dec 2003
135 enrolled
Upper Limb Spasticity
Career Relevance
ZANAFLEX roles are limited and declining due to LOE-approaching status; career mobility on this product is constrained. Professionals should expect consolidation and potential portfolio transitions as generic competition intensifies.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.