cenegermin-bkbj, Recombinant human nerve growth factor; rhNGF; human beta-nerve growth factor (beta-NGF)-(1-118) peptide (non-covalent dimer) produced in Escherichia coli[1]
AHFS/Drugs.com
Monograph
MedlinePlus
a619001
License data
US DailyMed: Cenegermin
Pregnancy category
AU: B3
Routes of administration
Ophthalmic
ATC code
S01XA24 (WHO)
Legal status
Legal status
AU: S4 (Prescription only)[2][3]
CA: ℞-only / Schedule D[4]
US: ℞-only
EU: Rx-only
Identifiers
CAS Number
1772578-74-1
DrugBank
DB13926
ChemSpider
None
UNII
B6E7K36KT8
KEGG
D11028
Chemical and physical data
Formula
C583H908N166O173S8
Molar mass
13267.15 g·mol−1
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.[5][1]
As a recombinant form of NGF, cenegermin is a peripherally selective agonist of the TrkA and LNGFR (p75NTR) which must be administered parenterally.[6]
The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]
^ abWorld Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1): 76. hdl:10665/330984.
^"AusPAR: Cenegermin". Therapeutic Goods Administration (TGA). 23 December 2019. Archived from the original on 1 November 2021. Retrieved 26 August 2020.
^"Oxervate APMDS". Therapeutic Goods Administration (TGA). 26 May 2022. Retrieved 10 March 2024.
^"Summary Basis of Decision (SBD) for Oxervate". Health Canada. 23 October 2014. Retrieved 29 May 2022.
^"Oxervate EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 25 August 2020.
^Cite error: The named reference AdisInsight was invoked but never defined (see the help page).
^New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.
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