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 |
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
1398 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Muscle spasticity | D009128 | — | — | 10 | 20 | 48 | 26 | 85 | 180 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 8 | 18 | 26 | 29 | 36 | 111 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 6 | 11 | 29 | 15 | 46 | 102 |
| Cerebral palsy | D002547 | — | G80 | 3 | 11 | 22 | 7 | 53 | 91 |
| Dystonia | D004421 | — | — | 7 | 16 | 15 | 12 | 37 | 81 |
| Dystonic disorders | D020821 | — | G24 | 7 | 15 | 15 | 9 | 33 | 73 |
| Torticollis | D014103 | — | F45.8 | 6 | 13 | 13 | 12 | 27 | 69 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 3 | 9 | 15 | 14 | 25 | 63 |
| Syndrome | D013577 | — | — | 13 | 26 | 10 | 6 | 10 | 56 |
| Urinary incontinence | D014549 | — | R32 | 4 | 7 | 15 | 12 | 10 | 44 |
Show 153 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Traumatic brain injuries | D000070642 | — | S06 | — | 4 | 5 | — | 5 | 13 |
| Sialorrhea | D012798 | — | K11.7 | — | 5 | 9 | — | 2 | 13 |
| Equinus deformity | D004863 | — | — | — | 1 | 1 | — | 9 | 11 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 3 | 5 | 2 | — | 3 | 10 |
| Talipes | D000070558 | — | Q66.1 | — | 1 | 1 | — | 8 | 10 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | 1 | 2 | 1 | — | 5 | 9 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | 2 | 7 | 2 | — | — | 9 |
| Tennis elbow | D013716 | EFO_1001896 | M77.1 | — | — | 5 | — | 4 | 9 |
| Ganglion cysts | D045888 | — | M67.4 | 2 | 4 | 2 | — | 1 | 7 |
| Vulvodynia | D056650 | — | N94.81 | — | 2 | 3 | — | 2 | 7 |
Show 65 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Muscle cramp | D009120 | — | — | 1 | 3 | — | — | 3 | 6 |
| Myalgia | D063806 | — | M79.1 | — | 1 | — | — | 2 | 3 |
| Abdominal hernia | D046449 | — | K46 | — | 1 | — | — | 2 | 3 |
| Internal hernia | D000082122 | — | — | — | 1 | — | — | 2 | 3 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | 1 | — | — | 2 | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | 2 | 3 |
| Neck pain | D019547 | — | M54.2 | 2 | 1 | — | — | 1 | 3 |
| Carpal tunnel syndrome | D002349 | EFO_0004143 | G56.0 | — | 3 | — | — | — | 3 |
| Ventral hernia | D006555 | EFO_1001866 | K43 | — | 1 | — | — | 1 | 2 |
| Pancreatic fistula | D010185 | — | — | — | 1 | — | — | 1 | 2 |
Show 75 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neurologic gait disorders | D020233 | — | R26.1 | 1 | — | — | — | 2 | 3 |
| Hemorrhagic stroke | D000083302 | — | — | 1 | — | — | — | 2 | 3 |
| Complex regional pain syndromes | D020918 | EFO_1001998 | — | 1 | — | — | — | 2 | 3 |
| Reflex sympathetic dystrophy | D012019 | EFO_1001147 | G90.5 | 1 | — | — | — | 2 | 3 |
| Skin abnormalities | D012868 | — | Q82.9 | 1 | — | — | — | 1 | 2 |
| Parkinsonian disorders | D020734 | — | G20.C | 1 | — | — | — | 1 | 2 |
| Intracranial sinus thrombosis | D012851 | — | — | 1 | — | — | — | — | 1 |
| Internal carotid artery dissection | D020215 | — | — | 1 | — | — | — | — | 1 |
| Vertebral artery dissection | D020217 | — | I77.74 | 1 | — | — | — | — | 1 |
| Vascular headaches | D014653 | — | — | 1 | — | — | — | — | 1 |
Show 16 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ultrasonography | D014463 | — | — | — | — | — | — | 2 | 2 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 2 | 2 |
| Movement disorders | D009069 | EFO_0004280 | G25 | — | — | — | — | 2 | 2 |
| Activities of daily living | D000203 | — | — | — | — | — | — | 1 | 1 |
| Pancreatectomy | D010180 | EFO_0002581 | — | — | — | — | — | 1 | 1 |
| Treatment outcome | D016896 | — | — | — | — | — | — | 1 | 1 |
| Muscle tonus | D009129 | — | — | — | — | — | — | 1 | 1 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | — | 1 | 1 |
| Endoscopy | D004724 | — | — | — | — | — | — | 1 | 1 |
| Physical therapy modalities | D026741 | — | — | — | — | — | — | 1 | 1 |
Show 57 more
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 | — |
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Estimated US medical usage
Onabotulinumtoxina
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 9,432 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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80,035 adverse events reported
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