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Onabotulinumtoxina
Botox (onabotulinumtoxina) is an unknown pharmaceutical. Onabotulinumtoxina was first approved as Botox cosmetic on 1991-12-09. It is used to treat blepharospasm, dystonia, fissure in ano, genetic skin diseases, and hyperhidrosis amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
digestive system diseasesD004066
nervous system diseasesD009422
eye diseasesD005128
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Botox, Botox cosmetic
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Onabotulinumtoxina
Tradename
Proper name
Company
Number
Date
Products
Botox CosmeticonabotulinumtoxinAAllergan, Inc.N-103000 RX1991-12-09
2 products
Botox onabotulinumtoxinAAllergan, Inc.N-103000 RX1991-12-09
2 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
botoxBiologic Licensing Application2022-08-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
blepharospasmD001764G24.5
dystoniaHP_0001332D004421G24
fissure in anoHP_0012390D005401K60.2
genetic skin diseasesD012873
hyperhidrosisHP_0000975D006945
migraine disordersEFO_0003821D008881G43
muscle rigidityHP_0002063D009127
overactive urinary bladderEFO_1000781D053201N32.81
strabismusHP_0000486D013285H50.2
Agency Specific
FDA
EMA
Expiration
Code
onabotulinumtoxina, Botox , Allergan, Inc.
2026-06-20Orphan excl.
onabotulinumtoxina, Botox Cosmetic, Allergan, Inc.
2026-06-20Orphan excl.
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code
Description
J0585
Injection, onabotulinumtoxina, 1 unit
Clinical
Clinical Trials
17 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E8411
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Soft tissue infectionsD01846133
Bacterial infectionsD001424A49123
Infectious skin diseasesD012874112
Bacterial pneumoniaD018410EFO_1001272J15.922
Community-acquired infectionsD01771411
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PyelonephritisD011704EFO_1001141N10-N1611
Urinary tract infectionsD014552EFO_0003103N39.011
CystitisD003556EFO_1000025N3011
Bacterial skin diseasesD01719211
Lung diseasesD008171EFO_0003818J98.411
Nontuberculous mycobacterium infectionsD009165EFO_0007461A31.911
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wound infectionD01494611
Healthy volunteers/patients11
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameONABOTULINUMTOXINA
INN
Description
Botulinum neurotoxin type A precursor (BoNT/A) (Bontoxilysin A)
Classification
Neurotoxin
Drug classcannabinol derivatives
Image (chem structure or protein)ONABOTULINUMTOXINA
Structure (InChI/SMILES or Protein Sequence)
>2VU9:A|BOTULINUM NEUROTOXIN A HEAVY CHAIN MGSSHHHHHHSSGLVPRGSHMDTSILNLRYESNHLIDLSRYASKINIGSKVNFDPIDKNQIQLFNLESSKIEVILKNAIV YNSMYENFSTSFWIRIPKYFNSISLNNEYTIINCMENNSGWKVSLNYGEIIWTLQDTQEIKQRVVFKYSQMINISDYINR WIFVTITNNRLNNSKIYINGRLIDQKPISNLGNIHASNNIMFKLDGCRDTHRYIWIKYFNLFDKELNEKEIKDLYDNQSN SGILKDFWGDYLQYDKPYYMLNLYDPNKYVDVNNVGIRGYMYLKGPRGSVMTTNIYLNSSLYRGTKFIIKKYASGNKDNI VRNNDRVYINVVVKNKEYRLATNASQAGVEKILSALEIPDVGNLSQVVVMKSKNDQGITNKCKMNLQDNNGNDIGFIGFH QFNNIAKLVASNWYNRQIERSSRTLGCSWEFIPVDDGWGERPLQ
Identifiers
PDB2G7P, 2VU9, 2VUA, 3BTA, 3DDA, 3DDB, 3DS9, 3DSE, 3FUO, 3K3Q, 3QIX, 3QIY, 3QIZ, 3QJ0, 3QW5, 3QW6, 3QW7, 3QW8, 3ZUR, 3ZUS, 4EJ5, 4EL4, 4ELC, 4HEV, 4IQP, 4JRA, 4KS6, 4KTX, 4KUF, 4ZJX, 5JLV, 5JMC, 5L21, 5MK6, 5MK7, 5MOY, 5TPB, 5TPC, 5V8P, 5V8R, 5V8U, 5VGV, 5VGX, 6DKK, 6ES1, 6MHJ, 6XCB, 6XCC, 6XCD, 6XCE, 6XCF, 7N18
CAS-ID
RxCUI
ChEMBL IDCHEMBL1201574
ChEBI ID
PubChem CID
DrugBankDB00083
UNII ID
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Botox - Allergan
$
£
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Botox - Warner Chilcott
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,954 documents
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Safety
Black-box Warning
Black-box warning for: Botox
Adverse Events
Top Adverse Reactions
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226 adverse events reported
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