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Also known as Tizanidine (sublingual or oral), Sublingual Tizanidine HCl
Tizanidine · 2 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| Tizanidine (sublingual or oral) | DRUG | - |
| Sublingual Tizanidine HCl | DRUG | - |
Inclusion Criteria: * Male and female patients between the ages of 20-65 * Definitive diagnosis of MS, with Expanded Disability Status Scale (EDSS) less than 6.5 at screening * Has significant spasticity (total Ashworth =\> 6) at screening * Can maintain sleep regimens of at least 5 hours nightly f...
Tizanidine is a small molecule under development for muscle spasticity and traumatic brain injury. It is being studied in a sublingual form for nighttime dosing in multiple sclerosis patients with significant spasticity, and in children with chronic traumatic brain injury. It is investigational and not approved for these uses.
Tizanidine targets the alpha-2 adrenergic receptors ADRA2A, ADRA2B, and ADRA2C, where it acts as an agonist. By activating these receptors, it is designed to reduce spasticity. This receptor activity is the basis for its development in muscle spasticity and traumatic brain injury.
Tizanidine is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is studying a sublingual formulation of tizanidine for muscle spasticity and traumatic brain injury.
Tizanidine is in Phase 1 development. It is investigational and has not been approved by the FDA for muscle spasticity or traumatic brain injury. The clinical program consists of completed early-stage trials, with no active trials currently listed.
Tizanidine has been studied in two completed Phase 1 trials. NCT00358293 evaluated nighttime sublingual tizanidine 12 mg in multiple sclerosis patients with significant spasticity, enrolling 20 participants in Israel. NCT00287157 was a pilot proof-of-concept study of sublingual tizanidine in children with chronic traumatic brain injury, enrolling 5 participants in Israel.
Yes. Tizanidine, sublingual tizanidine, and sublingual tizanidine HCl refer to the same drug asset. The sublingual form is the formulation being studied in the clinical program for muscle spasticity and traumatic brain injury.