NDAORALCAPSULE
Approved
Aug 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — 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 2002.
Drug data last refreshed 10h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZANAFLEX (tizanidine HCl) is an oral alpha-2-adrenergic receptor agonist approved for treating spasticity in adults. It reduces spasticity by increasing presynaptic inhibition of motor neurons, with greatest effects on polysynaptic pathways. The mechanism facilitates reduction of spinal motor neuron facilitation.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure; teams should expect portfolio transition planning and potential downsizing.
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 offers minimal career growth opportunity due to approaching loss of exclusivity and zero linked job openings. Professionals joining this team should expect focus on margin protection, generic defense, and potential role elimination.
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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.