Daxibotulinumtoxina
Daxxify (daxibotulinumtoxina) is an unknown pharmaceutical. Daxibotulinumtoxina was first approved as Daxxify on 2022-09-07.
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Therapeutic Areas
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Trade Name
FDA
EMA
Daxxify
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)
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 |
|---|---|---|
| daxxify | Biologic Licensing Application | 2022-09-19 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
757 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 5 | 10 | 17 | 15 | 14 | 58 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 4 | 9 | 15 | 13 | 5 | 43 |
| Cerebral palsy | D002547 | G80 | 2 | 7 | 13 | 4 | 11 | 35 | |
| Muscle spasticity | D009128 | HP_0001257 | 1 | 5 | 11 | 8 | 10 | 35 | |
| Torticollis | D014103 | HP_0000473 | F45.8 | 4 | 8 | 10 | 7 | 5 | 32 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 2 | 5 | 9 | 6 | 6 | 26 |
| Urinary incontinence | D014549 | HP_0000020 | R32 | 1 | 4 | 10 | 5 | 5 | 24 |
| Urge urinary incontinence | D053202 | EFO_0006865 | N39.41 | 3 | 2 | 5 | 4 | 2 | 14 |
| Hyperhidrosis | D006945 | HP_0000975 | 3 | 2 | 2 | 4 | 3 | 14 | |
| Blepharospasm | D001764 | G24.5 | 1 | 3 | 5 | 4 | 2 | 13 |
Show 69 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tennis elbow | D013716 | EFO_1001896 | M77.1 | — | — | 4 | — | 3 | 7 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | 1 | 2 | 2 | — | 1 | 6 | |
| Sialorrhea | D012798 | HP_0002307 | K11.7 | — | 5 | 3 | — | 1 | 6 |
| Plantar fasciitis | D036981 | EFO_1001909 | M72.2 | — | 3 | 2 | — | 2 | 5 |
| Vulvodynia | D056650 | N94.81 | — | 1 | 3 | — | — | 4 | |
| Temporomandibular joint disorders | D013705 | M26.6 | 1 | 1 | 2 | — | 1 | 4 | |
| Headache | D006261 | HP_0002315 | R51 | — | — | 2 | — | 2 | 4 |
| Dystonic disorders | D020821 | G24 | — | 1 | 1 | — | 2 | 3 | |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | 3 | 2 | — | — | 3 |
| Cluster headache | D003027 | HP_0012199 | G44.00 | 2 | 2 | 1 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lower urinary tract symptoms | D059411 | EFO_0008008 | 1 | 1 | — | — | 1 | 3 | |
| Smiling | D012904 | — | 1 | — | — | 1 | 2 | ||
| Abdominal hernia | D046449 | K46 | — | 1 | — | — | 1 | 2 | |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 1 | — | — | — | 2 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | 2 | — | — | — | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | 1 | 2 |
| Back pain | D001416 | HP_0003418 | M54 | — | 1 | — | — | 1 | 2 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | 2 | — | — | — | 2 |
| Neck pain | D019547 | HP_0030833 | M54.2 | 1 | 1 | — | — | 1 | 2 |
| Contracture | D003286 | EFO_0003899 | M62.4 | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | — | — | — | — | 2 |
| Hemorrhagic stroke | D000083302 | 1 | — | — | — | — | 1 | ||
| Internal carotid artery dissection | D020215 | 1 | — | — | — | — | 1 | ||
| Vertebral artery dissection | D020217 | I77.74 | 1 | — | — | — | — | 1 | |
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
| Gingival overgrowth | D019214 | K06.1 | 1 | — | — | — | — | 1 | |
| Treatment-resistant depressive disorder | D061218 | 1 | — | — | — | — | 1 | ||
| Complex regional pain syndromes | D020918 | EFO_1001998 | 1 | — | — | — | — | 1 | |
| Secondary headache disorders | D051271 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Strabismus | D013285 | HP_0000486 | H50.2 | — | — | — | — | 2 | 2 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | — | — | — | 2 | 2 |
| Constipation | D003248 | HP_0002019 | K59.0 | — | — | — | — | 2 | 2 |
| Treatment outcome | D016896 | — | — | — | — | 1 | 1 | ||
| Dystonia | D004421 | HP_0001332 | G24 | — | — | — | — | 1 | 1 |
| Skin abnormalities | D012868 | HP_0000951 | Q82.9 | — | — | — | — | 1 | 1 |
| Muscle tonus | D009129 | — | — | — | — | 1 | 1 | ||
| Physical therapy modalities | D026741 | — | — | — | — | 1 | 1 | ||
| Dysphonia | D055154 | R49.0 | — | — | — | — | 1 | 1 | |
| Urologic diseases | D014570 | N39.9 | — | — | — | — | 1 | 1 |
Show 22 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DAXIBOTULINUMTOXINA |
| INN | — |
| Description | Botulinum toxin, or botulinum neurotoxin (BoNT), is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It is also known as Botulin, the density of which is predicted to be 1.5±0.1 g/cm3.
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 | Unknown |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707359 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00083 |
| UNII ID | — |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
Daxxify - Revance Therapeutics
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Trends
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Additional graphs summarizing 50 documents
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Safety
Black-box Warning
Black-box warning for: Daxxify
Adverse Events
Top Adverse Reactions
0 adverse events reported
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