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Zanaflex (TIZANIDINE)
Zanaflex (Tizanidine) is a central alpha-2 adrenergic agonist small molecule developed by ACORDA and currently owned by Legacy Pharma Usa. It targets the Nischarin protein and was FDA approved in 1996 for treating muscle spasticity of cerebral and spinal origin. Zanaflex is off-patent with 23 generic manufacturers, offering a commercial alternative to branded options. Key safety considerations include its short half-life of 2.4 hours and bioavailability of 21%. As an off-patent medication, Zanaflex is widely available in the market.
At a glance
| Generic name | TIZANIDINE |
|---|---|
| Sponsor | Legacy Pharma Usa |
| Drug class | Central alpha-2 Adrenergic Agonist |
| Target | Nischarin |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Muscle Spasticity of Cerebral Origin
- Muscle spasticity of spinal origin
- Spasticity
Common side effects
- Somnolence
- Dry mouth
- Asthenia
- Dizziness
- Hypotension
- Bradycardia
- Fatigue
- Muscle spasms
- Hallucinations
- Liver function test abnormality
- Hepatotoxicity
- Convulsion
Drug interactions
- estradiol
- ethinylestradiol
- etonogestrel
- levonorgestrel
- norethisterone
- saquinavir
- valaciclovir
- verapamil
- zileuton
Key clinical trials
- Interaction of CYP2B6 Genotype and Efavirenz With Methadone and Tizanidine PK (EARLY_PHASE1)
- Opioid-Free Pain Protocol After Shoulder Arthroplasty (PHASE4)
- Efficacy and Safety of Pregabalin/Tizanidine vs. Pregabalin in Patients With Fibromyalgia (NA)
- Bi-level Erector Spinae Plane Block and Pre-emptive Oral Tizanidine for Analgesia After Mastectomy Surgery (NA)
- Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm (PHASE3)
- Comparison of Analgesic Efficacy of Intrathecal Levobupivacaine With and Without Oral Tizanidine in Lower Limb Surgeries: A Prospective Randomized Study (PHASE4)
- Tizanidine and Acoustic Reflex (NA)
- Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zanaflex CI brief — competitive landscape report
- Zanaflex updates RSS · CI watch RSS
- Legacy Pharma Usa portfolio CI