Prademagene zamikeracel
Zevaskyn (prademagene zamikeracel) is a gene pharmaceutical. Prademagene zamikeracel was first approved as Zevaskyn on 2025-04-28.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Zevaskyn
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)
Prademagene zamikeracel
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| zevaskyn | Prademagene zamikeracel | Abeona Therapeutics | N-125807 RX | 2025-04-28 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zevaskyn | Biologic Licensing Application | 2025-04-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| epidermolysis bullosa dystrophica | — | D016108 | Q81.2 |
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
4 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epidermolysis bullosa | D004820 | — | Q81 | — | — | 2 | — | 1 | 3 |
| Epidermolysis bullosa dystrophica | D016108 | — | Q81.2 | — | — | 2 | — | 1 | 3 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Prademagene zamikeracel |
| INN | prademagene zamikeracel |
| Description | Prademagene zamikeracel is a gene pharmaceutical. It is currently being investigated in clinical studies. |
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594312 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB17895 |
| UNII ID | 4UU2O40RHU (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 49 documents
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Safety
Black-box Warning
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Adverse Events
0 adverse events reported
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