Tizanidine
Ontralfy, Tizanidine, Zanaflex (tizanidine) is a small molecule pharmaceutical. Tizanidine was first approved as Zanaflex on 1996-11-27. It is used to treat low back pain, muscle cramp, muscle rigidity, muscle spasticity, and myositis amongst others in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Tizanidine (discontinued: Tizanidine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ontralfy | New Drug Application | 2024-12-20 |
| tizanidine | ANDA | 2025-06-03 |
| tizanidine hcl | ANDA | 2024-12-31 |
| tizanidine hydrochloride | ANDA | 2025-05-16 |
| zanaflex | New Drug Application | 2025-05-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myositis | EFO_0000783 | D009220 | G72.49 |
| low back pain | — | D017116 | M54.5 |
| muscle spasticity | — | D009128 | — |
| trigeminal neuralgia | EFO_1001219 | D014277 | G50.0 |
| muscle cramp | — | D009120 | — |
| spasm | — | D013035 | M62.83 |
| muscle rigidity | — | D009127 | — |
Agency Specific
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Clinical
Clinical Trials
38 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Muscle spasticity | D009128 | — | — | 3 | 3 | 1 | 1 | — | 6 |
| Back pain | D001416 | — | M54 | — | 1 | 4 | 1 | — | 6 |
| Low back pain | D017116 | — | M54.5 | — | 1 | 3 | 1 | — | 5 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | 1 | 1 | 2 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | 1 | — | 1 | — | 2 |
| Thyroidectomy | D013965 | — | — | — | — | — | 1 | — | 1 |
| Inguinal hernia | D006552 | HP_0000023 | K40 | — | — | — | 1 | — | 1 |
| Hernia | D006547 | — | K40-K46 | — | — | — | 1 | — | 1 |
| Postoperative complications | D011183 | — | — | — | — | — | 1 | — | 1 |
| Spinal diseases | D013122 | — | M45-M49 | — | — | — | 1 | — | 1 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Spinal cord injuries | D013119 | EFO_1001919 | — | 3 | — | 1 | — | — | 4 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 2 | 1 | — | — | 3 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | 1 | — | 1 | 2 |
| Spasm | D013035 | — | M62.83 | — | — | 1 | — | 1 | 2 |
| Radiculopathy | D011843 | — | M54.1 | — | — | 1 | — | 1 | 2 |
| Chronic pain | D059350 | — | — | — | 1 | 1 | — | — | 2 |
| Sclerosis | D012598 | — | — | 1 | 1 | 1 | — | — | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | — | 1 | — | — | 2 |
| Migraine without aura | D020326 | EFO_0005296 | G43.0 | — | — | 1 | — | — | 1 |
| Migraine with aura | D020325 | EFO_0005295 | G43.1 | — | — | 1 | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wounds and injuries | D014947 | — | T14.8 | 3 | — | — | — | — | 3 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Cerebral palsy | D002547 | — | G80 | 1 | — | — | — | — | 1 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | — | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Headache | D006261 | — | R51 | — | — | — | — | 2 | 2 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | — | — | 1 | 1 |
| Synovitis | D013585 | EFO_0008997 | M67.5 | — | — | — | — | 1 | 1 |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | — | 1 | 1 |
| Muscle hypotonia | D009123 | — | — | — | — | — | — | 1 | 1 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 1 | 1 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | — | — | 1 | 1 |
| Mastectomy | D008408 | — | — | — | — | — | — | 1 | 1 |
| Post-traumatic headache | D051298 | — | G44.3 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tizanidine |
| INN | tizanidine |
| Description | Tizanidine is 2,1,3-Benzothiadiazole substituted at C-4 by a Delta(1)-imidazolin-2-ylamino group and at C-4 by a chloro group. It is an agonist at alpha2-adrenergic receptor sites. It has a role as an alpha-adrenergic agonist and a muscle relaxant. It is a benzothiadiazole and a member of imidazoles. |
| Classification | Small molecule |
| Drug class | α2-adrenergic receptor agonist |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Clc1ccc2nsnc2c1NC1=NCCN1 |
Identifiers
| PDB | — |
| CAS-ID | 51322-75-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1079 |
| ChEBI ID | 63629 |
| PubChem CID | 5487 |
| DrugBank | DB00697 |
| UNII ID | 6AI06C00GW (ChemIDplus, GSRS) |
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Zanaflex – Acorda Therapeutics
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Estimated US medical usage
Tizanidine
Total medical expenditures per year (USD, in millions)
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Trends
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Safety
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Adverse Events
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7,153 adverse events reported
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