Botox cosmetic, Nuceiva(botulinum toxin type a)
Nuceiva (botulinum toxin type a) is a protein pharmaceutical. Botulinum toxin type a was first approved as Nuceiva on 2019-09-27. It is used to treat blepharospasm, dystonia, fissure in ano, genetic skin diseases, and muscle rigidity amongst others in the USA. It has been approved in Europe to treat skin aging.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Botox, Daxxify, Dysport, Xeomin (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)
Abobotulinumtoxina
Incobotulinumtoxina
Daxibotulinumtoxina
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Daxxify | daxibotulinumtoxinA-lanm | Revance Therapeutics | N-761127 RX | 2022-09-07 | 2 products |
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
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| genetic skin diseases | — | D012873 | — |
| dystonia | — | D004421 | — |
| fissure in ano | — | D005401 | K60.2 |
| strabismus | — | D013285 | H50.2 |
| blepharospasm | — | D001764 | G24.5 |
| muscle rigidity | — | D009127 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
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ATC Codes
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HCPCS
No data
Clinical
Clinical Trials
1477 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 | — | — | 1 | 1 | 5 | 2 | 18 | 26 |
| Torticollis | D014103 | — | F45.8 | — | — | 6 | 1 | 5 | 12 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | 3 | 7 | 10 |
| Syndrome | D013577 | — | — | — | — | — | 1 | 1 | 2 |
| Post-traumatic headache | D051298 | — | G44.3 | — | — | — | 1 | — | 1 |
| Tremor | D014202 | — | R25.1 | — | — | — | 1 | — | 1 |
| Hemiplegia | D006429 | — | G81.0 | — | — | — | 1 | — | 1 |
| Compartment syndromes | D003161 | — | T79.A0 | — | — | — | 1 | — | 1 |
| Chronic exertional compartment syndrome | D000083182 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral palsy | D002547 | — | G80 | — | 1 | 2 | — | 2 | 5 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | 1 | 2 | — | — | 3 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 1 | 2 | — | — | 3 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 2 | 1 | — | — | 3 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | 1 | — | 1 | 2 |
| Urinary incontinence | D014549 | — | R32 | — | — | 2 | — | — | 2 |
| Low back pain | D017116 | — | M54.5 | — | 1 | 1 | — | — | 2 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | 2 | — | — | 2 |
| Hemifacial spasm | D019569 | — | — | — | — | 1 | — | 1 | 2 |
| Sclerosis | D012598 | — | — | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dystonic disorders | D020821 | — | G24 | 1 | 1 | — | — | 4 | 5 |
| Dystonia | D004421 | — | — | 1 | 1 | — | — | 4 | 5 |
| Blepharospasm | D001764 | — | G24.5 | — | 1 | — | — | 1 | 2 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 1 | — | — | — | 1 |
| Vulvodynia | D056650 | — | N94.81 | — | 1 | — | — | — | 1 |
| Hallux valgus | D006215 | — | — | — | 1 | — | — | — | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | 1 | — | — | — | 1 |
| Back pain | D001416 | — | M54 | — | 1 | — | — | — | 1 |
| Tardive dyskinesia | D000071057 | — | G24.01 | 1 | 1 | — | — | — | 1 |
| Fissure in ano | D005401 | — | K60.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Facies | D019066 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | — | — | — | 1 | 1 |
| Brain injuries | D001930 | — | S06.9 | — | — | — | — | 1 | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | — | 1 | 1 |
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | — | — | — | — | 1 | 1 |
| Tics | D020323 | — | — | — | — | — | — | 1 | 1 |
| Clubfoot | D003025 | — | Q66.0 | — | — | — | — | 1 | 1 |
| Equinus deformity | D004863 | — | — | — | — | — | — | 1 | 1 |
| Talipes | D000070558 | — | Q66.1 | — | — | — | — | 1 | 1 |
| Arm injuries | D001134 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Botulinum toxin type a |
| INN | — |
| Description | Botulinum toxin, or botulinum neurotoxin, is a highly potent neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction, thus causing flaccid paralysis. The toxin causes the disease botulism. The toxin is also used commercially for medical and cosmetic purposes.
|
| Classification | Neurotoxin |
| Drug class | fluoroquinolone derivatives, nonantibacterial indication (e.g., antineoplastic antibiotics) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297862 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00083 |
| UNII ID | — |
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Daxxify – Revance Therapeutics
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Botox – Allergan
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Botox – Warner Chilcott
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Estimated US medical usage
Botulinum toxin type a
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 14,957 documents
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Safety
Black-box Warning
Black-box warning for: Botox, Botox cosmetic, Daxxify, Dysport, Xeomin
Adverse Events
Top Adverse Reactions
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87,428 adverse events reported
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