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Oxervate (CENEGERMIN)
Oxervate works by binding to the high affinity nerve growth factor receptor to stimulate nerve growth and repair.
CENegermin (Oxervate), developed by Dompé Farmaceutici S.p.A., is a marketed drug for neurotrophic keratitis, a rare condition affecting corneal healing. Its key strength lies in its unique mechanism of action, binding to the high-affinity nerve growth factor receptor to promote nerve growth and repair, setting it apart from off-patent competitors like retinol and sodium chloride. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | CENEGERMIN |
|---|---|
| Sponsor | Dompe farmaceutici s.p.a. |
| Drug class | Recombinant Human Nerve Growth Factor [EPC] |
| Target | High affinity nerve growth factor receptor |
| Modality | Recombinant protein |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity.
Approved indications
- Neurotrophic keratitis
Common side effects
- eye pain
Key clinical trials
- Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (PHASE3)
- A Safety and Efficacy Study of 2 Dosing Regimens of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution Compared With Vehicle in Patients With Dry Eye Disease. (PHASE2)
- DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
- Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PHASE3)
- Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis (PHASE4)
- Corneal Neurotization vs. Cenergermin for Neurotrophic Keratitis: A Pilot Study (NA)
- DOMPE -MT Neurotrophic Keratitis (PHASE4)
- Corneal Nerves After Treatment With Cenegermin
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oxervate CI brief — competitive landscape report
- Oxervate updates RSS · CI watch RSS
- Dompe farmaceutici s.p.a. portfolio CI