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Valoctocogene roxaparvovec
Roctavian (valoctocogene roxaparvovec) is a gene pharmaceutical. Valoctocogene roxaparvovec was first approved as Roctavian on 2022-08-24.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
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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
6 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
Hemophilia aD006467EFO_0007267D663336
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Genetic therapyD015316111
Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVALOCTOCOGENE ROXAPARVOVEC
INNvaloctocogene roxaparvovec
Description
Valoctocogene roxaparvovec, sold under the brand name Roctavian, is a gene therapy for the treatment of hemophilia A. It was developed by BioMarin Pharmaceutical. Valoctocogene roxaparvovec is made of a virus (AAV5) that has been modified to contain the gene for factor VIII, which is lacking in patients with haemophilia A. It is given by intravenous infusion.
Classification
Gene
Drug classAntihemorrhagics
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID1819334-78-5
RxCUI
ChEMBL IDCHEMBL4297579
ChEBI ID
PubChem CID
DrugBankDB15561
UNII ID681K1JDI8M (ChemIDplus, GSRS)
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 134 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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