Cenegermin

Cenegermin

Clinical data
Trade names	Oxervate
Other names	Recombinant human nerve growth factor; rhNGF, cenegermin-bkbj
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) [1] [2] CA: ℞-only / Schedule D [3] US: ℞-only [4] EU:Rx-only [5]
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, is a recombinant form of human nerve growth factor. ^[4] Cenegermin is a peripherally selective agonist of the tropomyosin receptor kinase A (TrkA) and low-affinity nerve growth factor receptor (p75NTR). ^[4]

The most common side effects include eye pain and inflammation, increased lacrimation (watery eyes), pain in the eyelid and sensation of a foreign body in the eye. ^[5]

It was approved for medical use in the European Union in July 2017, ^[5] and in the United States in 2018. ^{[4] [6]} The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. ^[6]

Medical uses

Cenegermin is indicated for the treatment of neurotrophic keratitis. ^{[4] [5]}

Society and culture

Names

Cenegermin is the international nonproprietary name. ^[7] It is also known as human beta-nerve growth factor (beta-NGF)-(1-118) peptide (non-covalent dimer) produced in Escherichia coli . ^[7]

Cenegermin is sold under the brand name Oxervate. ^{[4] [5]}

References

1. "AusPAR: Cenegermin". Therapeutic Goods Administration (TGA). 23 December 2019. Archived from the original on 1 November 2021. Retrieved 26 August 2020.
2. "Oxervate APMDS". Therapeutic Goods Administration (TGA). 26 May 2022. Retrieved 10 March 2024.
3. "Summary Basis of Decision (SBD) for Oxervate". Health Canada . 23 October 2014. Retrieved 29 May 2022.
4. "Oxervate- cenegermin-bkbj kit; Oxervate- cenegermin-bkbj solution/ drops". DailyMed. 8 October 2024. Retrieved 26 October 2024.
5. "Oxervate EPAR". European Medicines Agency (EMA). 25 July 2017. Retrieved 25 August 2020.
6. New Drug Therapy Approvals 2018. U.S. Food and Drug Administration (FDA) (Report). January 2019. Archived from the original (PDF) on 26 August 2019. Retrieved 16 September 2020.
7. World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1): 76. hdl: 10665/330984 .

Further reading

• Deeks ED, Lamb YN (April 2020). "Cenegermin: A Review in Neurotrophic Keratitis". Drugs. 80 (5): 489–494. doi:10.1007/s40265-020-01289-w. PMID   32185680.
• Pflugfelder SC, Massaro-Giordano M, Perez VL, Hamrah P, Deng SX, Espandar L, et al. (January 2020). "Topical Recombinant Human Nerve Growth Factor (Cenegermin) for Neurotrophic Keratopathy: A Multicenter Randomized Vehicle-Controlled Pivotal Trial". Ophthalmology. 127 (1): 14–26. doi: 10.1016/j.ophtha.2019.08.020 . PMID   31585826.
• Sheha H, Tighe S, Hashem O, Hayashida Y (October 2019). "Update On Cenegermin Eye Drops In The Treatment Of Neurotrophic Keratitis". Clin Ophthalmol. 13: 1973–1980. doi: 10.2147/OPTH.S185184 . PMC   6789413 . PMID   31631965.