OXERVATE (cenegermin-bkbj)
OXERVATE is indicated for the treatment of Neurotrophic Keratitis.
How OXERVATE Works
Cenegermin-bkbj acts as a recombinant form of human nerve growth factor, an endogenous protein involved in the differentiation and maintenance of neurons. The drug targets specific high-affinity (TrkA) and low-affinity (p75NTR) nerve growth factor receptors located in the anterior segment of the eye. By interacting with these receptors, the medication supports corneal innervation and maintains the integrity of the ocular surface.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-08-22
- Patent Cliff
- 2025
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION
OXERVATE Approval History
What OXERVATE Treats
1 indicationsOXERVATE is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neurotrophic Keratitis
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04485546 DEFENDO results posted | NGF0120 | Ph 4 | completed | Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis |
| NCT05133180 results posted | NGF0121 2021-003346-21 | Ph 3 | completed | Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study) |
| NCT05700864 | STUDY00002840 | Ph 1 | withdrawn | NGF Treatment for Patients With Neuropathic Corneal Pain |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OXERVATE FDA Label Details
Indications & Usage
FDA Label (PDF)OXERVATE is indicated for the treatment of Neurotrophic Keratitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment