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Cenegermin

Generic Name
Cenegermin
Brand Names
Oxervate
Drug Type
Biotech
CAS Number
1772578-74-1
Unique Ingredient Identifier
B6E7K36KT8

Overview

Cenegermin is a human beta-nerve growth factor (beta-ngf)-(1-118)- peptide (non-covalent dimer) produced in escherichia coli. It received European Union Approval in July, 2017 for the treatment of moderate to severe neurotrophic keratitis. Cenegermin received approval from the US FDA a year later in August of 2018 . Neurotrophic keratitis is a degenerative disease resulting from a loss of corneal sensation . The loss of corneal sensation impairs corneal health causing progressive damage to the top layer of the cornea, including corneal thinning, ulceration, and perforation in severe cases . The prevalence of neurotrophic keratitis has been estimated to be less than five in 10,000 individuals . While the prevalence of neurotrophic keratitis is low, the impact of this serious condition and its associated sequelae on an individual patient can be debilitating. Many currently available therapeutic options for treating the condition involve surgical interventions - surgeries that are typically only palliative . The approval of cenegermin consequently provides a novel topical treatment that has the potential capacity to offer total corneal healing for many patients who may use the agent . In particular, cenegermin was granted Priority Review designation, under which the FDA’s goal is to take action on an application within six months of application filing where the agency determines that the drug, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition . Cenegermin also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases .

Indication

Cenegermin is indicated for the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults .

Associated Conditions

  • Neurotrophic Keratopathy

Research Report

Published: Sep 30, 2025

Report on Cenegermin (Oxervate®): A First-in-Class Recombinant Nerve Growth Factor for Neurotrophic Keratitis

Executive Summary

Cenegermin, marketed under the brand name Oxervate®, represents a paradigm shift in the management of neurotrophic keratitis (NK), a rare and degenerative corneal disease. It is a first-in-class, topical biologic therapy, distinguished as the first-ever recombinant human nerve growth factor (rhNGF) approved for ophthalmic use.[1] The therapeutic innovation of Cenegermin lies in its disease-modifying mechanism of action, which directly addresses the underlying pathophysiology of NK. By mimicking the function of endogenous nerve growth factor, it promotes the repair of damaged corneal nerves and stimulates the healing of the corneal epithelium, thereby restoring the trophic support that is lost in this condition.[3]

Pivotal, multicenter, randomized controlled trials have demonstrated the robust efficacy of Cenegermin in achieving complete corneal healing in a majority of patients with moderate to severe NK, a significant improvement over vehicle control.[6] The safety profile is well-characterized and considered manageable, with the most common adverse events being local to the eye, such as transient ocular pain, which may be indicative of the desired nerve regeneration process. The regulatory journey of Cenegermin was marked by multiple expedited pathway designations from global health authorities, including Orphan Drug, Breakthrough Therapy, Fast Track, and Priority Review status, underscoring the profound unmet medical need it addresses.[6]

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Dompé farmaceutici S.p.A.
71981-020
OPHTHALMIC
20 ug in 1 mL
3/30/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
OXERVATE cenegermin (rbe) 20 micrograms/mL eye drops, solution vials
310960
Medicine
A
9/30/2019

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
OXERVATE
02485613
Solution - Ophthalmic
0.002 %
2/18/2022

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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