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, Botox cosmetic
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| babybig | Biologic Licensing Application | 2021-06-30 |
| botox | Biologic Licensing Application | 2023-11-15 |
| botox cosmetic | Biologic Licensing Application | 2023-11-15 |
| daxxify | Biologic Licensing Application | 2024-01-24 |
| dysport | Biologic Licensing Application | 2023-09-30 |
| 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
1360 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 | HP_0001257 | — | 9 | 19 | 48 | 26 | 82 | 175 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 8 | 18 | 26 | 27 | 36 | 109 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 5 | 11 | 29 | 15 | 43 | 98 |
| Cerebral palsy | D002547 | — | G80 | 3 | 11 | 22 | 7 | 53 | 91 |
| Dystonia | D004421 | HP_0001332 | G24 | 7 | 15 | 15 | 12 | 37 | 80 |
| Dystonic disorders | D020821 | — | G24 | 7 | 14 | 15 | 9 | 33 | 72 |
| Torticollis | D014103 | HP_0000473 | F45.8 | 6 | 12 | 13 | 12 | 27 | 68 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 3 | 9 | 15 | 14 | 24 | 62 |
| Syndrome | D013577 | — | — | 12 | 24 | 10 | 6 | 9 | 53 |
| Urinary incontinence | D014549 | HP_0000020 | R32 | 4 | 7 | 15 | 12 | 10 | 44 |
Show 150 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sialorrhea | D012798 | HP_0002307 | K11.7 | — | 5 | 9 | — | 2 | 13 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 4 | 5 | — | 3 | 11 |
| Equinus deformity | D004863 | — | — | — | 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 |
| Talipes | D000070558 | HP_0001883 | Q66.1 | — | 1 | 1 | — | 7 | 9 |
| Tennis elbow | D013716 | EFO_1001896 | M77.1 | — | — | 5 | — | 3 | 8 |
| Ganglion cysts | D045888 | — | M67.4 | 2 | 4 | 2 | — | 1 | 7 |
| Vulvodynia | D056650 | — | N94.81 | — | 2 | 3 | — | 2 | 7 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 2 | 5 | 3 | — | — | 6 |
Show 58 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Muscle cramp | D009120 | HP_0003394 | — | 1 | 3 | — | — | 3 | 6 |
| Esophageal motility disorders | D015154 | — | K22.4 | — | 1 | — | — | 3 | 4 |
| Abdominal hernia | D046449 | — | K46 | — | 1 | — | — | 2 | 3 |
| Internal hernia | D000082122 | — | — | — | 1 | — | — | 2 | 3 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | — | 1 | — | — | 2 | 3 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | — | — | 2 | 3 |
| Neck pain | D019547 | HP_0030833 | M54.2 | 2 | 1 | — | — | 1 | 3 |
| Carpal tunnel syndrome | D002349 | EFO_0004143 | G56.0 | — | 3 | — | — | — | 3 |
| Myalgia | D063806 | HP_0003326 | M79.1 | — | 1 | — | — | 1 | 2 |
| Ventral hernia | D006555 | EFO_1001866 | K43 | — | 1 | — | — | 1 | 2 |
Show 77 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neurologic gait disorders | D020233 | HP_0003376 | 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 | HP_0000951 | Q82.9 | 1 | — | — | — | 1 | 2 |
| Parkinsonian disorders | D020734 | HP_0001300 | 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 14 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diffuse esophageal spasm | D015155 | EFO_1001785 | K22.4 | — | — | — | — | 3 | 3 |
| Ultrasonography | D014463 | — | — | — | — | — | — | 2 | 2 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 2 | 2 |
| Flushing | D005483 | — | R23.2 | — | — | — | — | 2 | 2 |
| Movement disorders | D009069 | HP_0100022 | — | — | — | — | — | 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 |
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 8,922 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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76,192 adverse events reported
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