Overview
Tizanidine is a fast-acting drug used for the management of muscle spasm, which may result from the effects of multiple sclerosis, stroke, an acquired brain injury, or a spinal cord injury . It may also be caused by musculoskeletal injury . Regardless of the cause, muscle spasticity can be an extremely painful and debilitating condition. Initially approved by the FDA in 1996, tizanidine is an Alpha-2 adrenergic receptor agonist reducing spasticity by the presynaptic inhibition of excitatory neurotransmitters that cause firing of neurons promoting muscle spasm .
Indication
Tizanidine is indicated for the relief of muscle spasticity, which can interfere with daily activities. The general recommendation is to reserve tizanidine use for periods of time when there is a particular need for relief, as it has a short duration of action .
Associated Conditions
- Acute Low Back Pain
- Drug Withdrawal Headache
- Insomnia
- Migraine
- Pain
- Seizures
- Spasticity, Muscle
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/30 | Early Phase 1 | Recruiting | |||
2024/04/24 | Phase 4 | Recruiting | |||
2024/03/12 | Phase 4 | Not yet recruiting | |||
2024/02/14 | Phase 3 | Recruiting | |||
2023/09/07 | Phase 3 | Not yet recruiting | |||
2022/08/05 | Phase 4 | Active, not recruiting | |||
2022/08/02 | Phase 3 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2020/10/05 | Not Applicable | UNKNOWN | |||
2020/06/12 | Phase 2 | Completed | |||
2017/03/03 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Quality Care Products, LLC | 35356-662 | ORAL | 2 mg in 1 1 | 6/15/2021 | |
| Northwind Pharmaceuticals, LLC | 51655-740 | ORAL | 4 mg in 1 1 | 1/26/2023 | |
| Northwind Pharmaceuticals | 51655-741 | ORAL | 4 mg in 1 1 | 1/25/2017 | |
| Bryant Ranch Prepack | 71335-1698 | ORAL | 6 mg in 1 1 | 8/11/2017 | |
| Asclemed USA, Inc. | 76420-231 | ORAL | 6 mg in 1 1 | 7/7/2022 | |
| Nivagen Pharmaceuticals, Inc. | 75834-207 | ORAL | 2 mg in 1 1 | 3/1/2019 | |
| Unit Dose Services | 50436-0251 | ORAL | 2 mg in 1 1 | 6/1/2017 | |
| Aurobindo Pharma Limited | 59651-314 | ORAL | 2 mg in 1 1 | 4/30/2021 | |
| Ascend Laboratories, LLC | 67877-613 | ORAL | 2 mg in 1 1 | 10/30/2022 | |
| Unit Dose Services | 50436-6756 | ORAL | 4 mg in 1 1 | 6/20/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tizanidine Hydrochloride Orally Disintegrating Tablets | 国药准字H20140147 | 化学药品 | 片剂 | 2/6/2024 | |
| Tizanidine Hydrochloride Orally Disintegrating Tablets | 国药准字H20140110 | 化学药品 | 片剂 | 2/6/2024 | |
| Tizanidine Hydrochloride Tablets | 国药准字H20050788 | 化学药品 | 片剂 | 12/18/2019 | |
| Tizanidine Hydrochloride Tablets | 国药准字H20060645 | 化学药品 | 片剂 | 12/18/2019 | |
| Tizanidine Hydrochloride Tablets | 国药准字H20041750 | 化学药品 | 片剂 | 7/9/2020 | |
| Tizanidine Hydrochloride Tablets | 国药准字H20060644 | 化学药品 | 片剂 | 12/18/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.