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Drug ReportsTizanidine
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
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
stomatognathic diseasesD009057
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
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
ontralfyNew Drug Application2024-12-20
tizanidineANDA2025-05-27
tizanidine hclANDA2024-12-31
tizanidine hydrochlorideANDA2025-05-16
zanaflexNew Drug Application2025-05-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myositisEFO_0000783D009220G72.49
low back painD017116M54.5
muscle spasticityD009128
trigeminal neuralgiaEFO_1001219D014277G50.0
muscle crampD009120
spasmD013035M62.83
muscle rigidityD009127
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
M: Musculo-skeletal system drugs
M03: Muscle relaxants
M03B: Muscle relaxants, centrally acting agents
M03BX: Other centrally acting agents in atc
M03BX02: Tizanidine
HCPCS
No data
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients22
MalnutritionD044342EFO_0008572E40-E4611
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTizanidine
INNtizanidine
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 classα2-adrenergic receptor agonist
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Structure (InChI/SMILES or Protein Sequence)
Clc1ccc2nsnc2c1NC1=NCCN1
Identifiers
PDB
CAS-ID51322-75-9
RxCUI
ChEMBL IDCHEMBL1079
ChEBI ID63629
PubChem CID5487
DrugBankDB00697
UNII ID6AI06C00GW (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Zanaflex Acorda Therapeutics
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Estimated US medical usage
Tizanidine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,446 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,013 adverse events reported
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