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Oxervate(cenegermin)
Oxervate (cenegermin) is a protein pharmaceutical. Cenegermin was first approved as Oxervate on 2017-07-06. It is used to treat keratitis in the USA. It has been approved in Europe to treat keratitis. The pharmaceutical is active against beta-nerve growth factor. In addition, it is known to target tumor necrosis factor receptor superfamily member 16.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
eye diseasesD005128
Trade Name
FDA
EMA
Oxervate
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)
Cenegermin
Tradename
Proper name
Company
Number
Date
Products
Oxervatecenegermin-bkbjDompé farmaceutici S.p.A.N-761094 RX2018-08-22
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
oxervateBiologic Licensing Application2020-10-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
keratitis—D007634H16
Agency Specific
FDA
EMA
Expiration
Code
cenegermin, Oxervate, Dompé farmaceutici S.p.A.
2025-08-22Orphan excl.
Patent Expiration
No data
ATC Codes
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01X: Other ophthalmologicals in atc
— S01XA: Other ophthalmologicals in atc
— S01XA24: Cenegermin
HCPCS
No data
Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Dry eye syndromesD015352H04.12——2——2
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Corneal diseasesD003316H18.91————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCENEGERMIN
INNcenegermin
Description
Cenegermin, sold under the brand name Oxervate, also known as recombinant human nerve growth factor (rhNGF), is a recombinant form of human nerve growth factor (NGF). In July 2017, it was approved in the European Union as an eye drop formulation for the treatment of moderate or severe neurotrophic keratitis in adults.
Classification
Protein
Drug classgrowth factors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4297852
ChEBI ID—
PubChem CID—
DrugBankDB13926
UNII IDB6E7K36KT8 (ChemIDplus, GSRS)
Target
Agency Approved
NGF
NGF
Organism
Homo sapiens
Gene name
NGF
Gene synonyms
NGFB
NCBI Gene ID
4803
Protein name
beta-nerve growth factor
Protein synonyms
nerve growth factor (beta polypeptide), nerve growth factor, beta subunit, pro-nerve growth factor long
Uniprot ID
Q9UKL8
Mouse ortholog
Ngf (18049)
beta-nerve growth factor (Q6LDB7)
Alternate
NGFR
NGFR
Organism
Homo sapiens
Gene name
NGFR
Gene synonyms
TNFRSF16
NCBI Gene ID
4804
Protein name
tumor necrosis factor receptor superfamily member 16
Protein synonyms
CD271, Gp80-LNGFR, Low affinity neurotrophin receptor p75NTR, Low-affinity nerve growth factor receptor, NGF receptor, p75 ICD, TNFR superfamily, member 16
Uniprot ID
P08138
Mouse ortholog
Ngfr (18053)
tumor necrosis factor receptor superfamily member 16 (Q9Z0W1)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 125 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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790 adverse events reported
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