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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
Zanaflex (generic drugs available since 2002-06-27)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tizanidine hydrochloride
Tradename
Company
Number
Date
Products
ZANAFLEXLEGACY PHARMAN-020397 RX1996-11-27
1 products, RLD, RS
ZANAFLEXLEGACY PHARMAN-021447 RX2002-08-29
3 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
tizanidineANDA2023-06-19
zanaflexNew Drug Application2020-12-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
low back painHP_0003419D017116M54.5
muscle crampHP_0003394D009120—
muscle rigidityHP_0002063D009127—
muscle spasticityHP_0001257D009128—
myositisEFO_0000783D009220G72.49
spasm—D013035M62.83
trigeminal neuralgiaEFO_1001219D014277G50.0
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
18 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SunburnD013471EFO_0003958L55———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Dental cariesD003731EFO_0003819K02—12—13
HemorrhageD006470MP_0001914R58——2——2
InfectionsD007239EFO_0000544——2——2
Postoperative complicationsD011183——2——2
PulpitisD011671EFO_1001139K04.0——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Denture stomatitisD013282EFO_1000893K12.11———23
Brain neoplasmsD001932EFO_0003833C711————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Metabolic syndromeD024821EFO_0000195E88.81————11
HypertensionD006973EFO_0000537I10————11
Cardiovascular diseasesD002318EFO_0000319I98————11
Vascular diseasesD014652EFO_0004264I77————11
Traumatic brain injuriesD000070642S06————11
PinealomaD010871————11
CandidiasisD002177B37————11
Dental anxietyD016854————11
Denture retentionD003781————11
Complete dentureD003824————11
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 class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Clc1ccc2nsnc2c1NC1=NCCN1
Identifiers
PDB—
CAS-ID51322-75-9
RxCUI57258
ChEMBL IDCHEMBL1079
ChEBI ID63629
PubChem CID5487
DrugBankDB00697
UNII ID6AI06C00GW (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Zanaflex - Acorda Therapeutics
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,861 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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473 adverse events reported
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