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
Trade Name
FDA
EMA
Botox (discontinued: Botox)
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 |
|---|---|---|
| babybig | Biologic Licensing Application | 2024-12-05 |
| botox | Biologic Licensing Application | 2023-11-18 |
| botox cosmetic | Biologic Licensing Application | 2024-10-18 |
| botox facial serum | C200263 | 2024-10-28 |
| botox serum | C200263 | 2024-11-03 |
| botox stock solution | C200263 | 2024-11-03 |
| botulinum toxin solution anti-aging serum | C200263 | 2024-10-21 |
| daxxify | Biologic Licensing Application | 2024-01-24 |
| dysport | Biologic Licensing Application | 2024-10-24 |
| protoxin | unapproved drug other | 2016-11-10 |
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Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
onabotulinumtoxina, Botox , AbbVie Inc. | |||
| 2026-06-20 | Orphan excl. | ||
onabotulinumtoxina, Botox Cosmetic, AbbVie 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
1409 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 1 | — | — | — | 1 |
| Essential tremor | D020329 | EFO_0003108 | G25.0 | — | 1 | — | — | — | 1 |
| Tremor | D014202 | — | R25.1 | — | 1 | — | — | — | 1 |
| Abdominal hernia | D046449 | — | K46 | — | 1 | — | — | — | 1 |
| Ventral hernia | D006555 | EFO_1001866 | K43 | — | 1 | — | — | — | 1 |
| Hernia | D006547 | — | K40-K46 | — | 1 | — | — | — | 1 |
| Internal hernia | D000082122 | — | — | — | 1 | — | — | — | 1 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 1 | — | — | — | 1 |
| Interstitial cystitis | D018856 | EFO_1000869 | N30.1 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Muscle spasticity | D009128 | — | — | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral palsy | D002547 | — | G80 | — | — | — | — | 1 | 1 |
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
No data
Variants
No data
Financial
Revenue by drug
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Botox – Allergan
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Botox – Warner Chilcott
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Tabular view
Estimated US medical usage
Onabotulinumtoxina
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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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,583 documents
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Safety
Black-box Warning
Black-box warning for: Botox, Botox cosmetic, Daxxify, Dysport
Adverse Events
Top Adverse Reactions
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82,229 adverse events reported
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