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 diseases | D009140 |
digestive system diseases | D004066 |
nervous system diseases | D009422 |
eye diseases | D005128 |
urogenital diseases | D000091642 |
hereditary congenital and neonatal diseases and abnormalities | D009358 |
skin and connective tissue diseases | D017437 |
signs and symptoms pathological conditions | D013568 |
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
botox | Biologic Licensing Application | 2022-08-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
blepharospasm | — | D001764 | G24.5 |
dystonia | HP_0001332 | D004421 | G24 |
fissure in ano | HP_0012390 | D005401 | K60.2 |
genetic skin diseases | — | D012873 | — |
hyperhidrosis | HP_0000975 | D006945 | — |
migraine disorders | EFO_0003821 | D008881 | G43 |
muscle rigidity | HP_0002063 | D009127 | — |
overactive urinary bladder | EFO_1000781 | D053201 | N32.81 |
strabismus | HP_0000486 | D013285 | H50.2 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
onabotulinumtoxina, Botox , Allergan, Inc. | |||
2026-06-20 | Orphan excl. | ||
onabotulinumtoxina, Botox Cosmetic, Allergan, Inc. | |||
2026-06-20 | Orphan 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 fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | 1 | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 1 | — | — | — | 1 |
Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 1 | — | — | — | 1 |
Cystitis | D003556 | EFO_1000025 | N30 | — | 1 | — | — | — | 1 |
Bacterial skin diseases | D017192 | — | 1 | — | — | — | 1 | ||
Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | — | — | — | 1 |
Nontuberculous mycobacterium infections | D009165 | EFO_0007461 | A31.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Wound infection | D014946 | 1 | — | — | — | — | 1 | ||
Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | ONABOTULINUMTOXINA |
INN | — |
Description | Botulinum neurotoxin type A precursor (BoNT/A) (Bontoxilysin A) |
Classification | Neurotoxin |
Drug class | cannabinol derivatives |
Image (chem structure or protein) | ![]() |
Structure (InChI/SMILES or Protein Sequence) | >2VU9:A|BOTULINUM NEUROTOXIN A HEAVY CHAIN
MGSSHHHHHHSSGLVPRGSHMDTSILNLRYESNHLIDLSRYASKINIGSKVNFDPIDKNQIQLFNLESSKIEVILKNAIV
YNSMYENFSTSFWIRIPKYFNSISLNNEYTIINCMENNSGWKVSLNYGEIIWTLQDTQEIKQRVVFKYSQMINISDYINR
WIFVTITNNRLNNSKIYINGRLIDQKPISNLGNIHASNNIMFKLDGCRDTHRYIWIKYFNLFDKELNEKEIKDLYDNQSN
SGILKDFWGDYLQYDKPYYMLNLYDPNKYVDVNNVGIRGYMYLKGPRGSVMTTNIYLNSSLYRGTKFIIKKYASGNKDNI
VRNNDRVYINVVVKNKEYRLATNASQAGVEKILSALEIPDVGNLSQVVVMKSKNDQGITNKCKMNLQDNNGNDIGFIGFH
QFNNIAKLVASNWYNRQIERSSRTLGCSWEFIPVDDGWGERPLQ |
Identifiers
PDB | 2G7P, 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 ID | CHEMBL1201574 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB00083 |
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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