Cenegermin

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.[4][1]

Cenegermin
Clinical data
Trade namesOxervate
Other namescenegermin-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.comMonograph
MedlinePlusa619001
License data
Pregnancy
category
  • AU: B3
Routes of
administration
Ophthalmic
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only) [2]
  • CA: Rx-only / Schedule D [3]
  • US: ℞-only
  • EU: Rx-only
Identifiers
CAS Number
DrugBank
ChemSpider
  • None
UNII
KEGG
Chemical and physical data
FormulaC583H908N166O173S8
Molar mass13267.15 g·mol−1

As a recombinant form of NGF, cenegermin is a peripherally selective agonist of the TrkA and LNGFR (p75NTR) which must be administered parenterally.[5]

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[6]

History

It was developed by Anabasis Pharma, Dompé Farmaceutici, and Ospedale San Raffaele.[5]

Research

In addition to neurotrophic keratitis, cenegermin is also under development for the treatment of dry eyes, retinitis pigmentosa, and glaucoma.[5]

References

  1. World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1): 76. hdl:10665/330984.
  2. "AusPAR: Cenegermin". Therapeutic Goods Administration (TGA). 23 December 2019.
  3. "Summary Basis of Decision (SBD) for Oxervate". Health Canada. 23 October 2014. Retrieved 29 May 2022.
  4. "Oxervate EPAR". European Medicines Agency (EMA). Retrieved 25 August 2020.
  5. "Cenegermin - Dompe Farmaceutici - AdisInsight". adisinsight.springer.com. Retrieved 2020-06-05.
  6. New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.

Further reading

  • "Cenegermin". Drug Information Portal. U.S. National Library of Medicine.


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