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Neurotrophic Keratitis

9
Pipeline Programs
7
Companies
10
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
3
3
0
0
3
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

OXERVATEApproved
cenegermin-bkbj
Unknown Company
Recombinant Human Nerve Growth Factor [EPC]ophthalmic2018
493M Part D

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Dompé
DompéItaly - L'Aquila
6 programs
1
1
2
OXERVATE® 0.002%Phase 41 trial
cenegermin-bkbjPhase 41 trial
rhNGF 20µg/mlPhase 21 trial
rhNGF 10 μg/mlPhase 1/21 trial
Cenegemin in the DEFENDO StudyN/A1 trial
+1 more programs
Active Trials
NCT05552261Completed24Est. Apr 2024
NCT01756456Completed174Est. May 2016
NCT02227147Completed48Est. Sep 2016
+2 more trials
BRIM Biotechnology
BRIM BiotechnologyTaiwan - Taipei
1 program
1
BRM424Phase 21 trial
Active Trials
NCT05927428Recruiting12Est. Nov 2025
Syneos Health
Syneos HealthNC - Morrisville
1 program
1
UdonitrectagPhase 21 trial
Active Trials
NCT04276558Completed108Est. Apr 2024
BioTherapeutics Inc
BioTherapeutics IncVA - Blacksburg
1 program
1
CSB-001 Ophthalmic Solution 0.1%Phase 1/21 trial
Active Trials
NCT04909450Completed131Est. Jun 2024
Krystal Biotech
Krystal BiotechPA - Pittsburgh
1 program
1
KB801Phase 1/21 trial
Active Trials
NCT06999733Recruiting60Est. Dec 2027
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
Cenegermin Ophthalmic Solution [Oxervate]N/A1 trial
Active Trials
NCT04627571Completed8Est. Mar 2025
Recordati
RecordatiFrance - Saint-Victor
1 program
UdonitrectagPHASE_2

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
DompéOXERVATE® 0.002%
Dompécenegermin-bkbj
BRIM BiotechnologyBRM424
Syneos HealthUdonitrectag
DompérhNGF 20µg/ml
Krystal BiotechKB801
BioTherapeutics IncCSB-001 Ophthalmic Solution 0.1%
DompérhNGF 10 μg/ml
DompéCenegemin in the DEFENDO Study
Angeles TherapeuticsCenegermin Ophthalmic Solution [Oxervate]

Clinical Trials (10)

Total enrollment: 602 patients across 10 trials

NCT06411145DompéOXERVATE® 0.002%

Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis

Start: Apr 2024Est. completion: Nov 20240
Phase 4Withdrawn
NCT04485546Dompécenegermin-bkbj

Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis

Start: Sep 2020Est. completion: Mar 202237 patients
Phase 4Completed
NCT05927428BRIM BiotechnologyBRM424

Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis

Start: Jul 2024Est. completion: Nov 202512 patients
Phase 2Recruiting
NCT04276558Syneos HealthUdonitrectag

REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients

Start: Oct 2020Est. completion: Apr 2024108 patients
Phase 2Completed
NCT02227147DompérhNGF 20µg/ml

Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK

Start: Feb 2015Est. completion: Sep 201648 patients
Phase 2Completed
NCT06999733Krystal BiotechKB801

A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis

Start: Jul 2025Est. completion: Dec 202760 patients
Phase 1/2Recruiting
NCT04909450BioTherapeutics IncCSB-001 Ophthalmic Solution 0.1%

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects

Start: Aug 2021Est. completion: Jun 2024131 patients
Phase 1/2Completed
NCT01756456DompérhNGF 10 μg/ml

Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.

Start: Jan 2013Est. completion: May 2016174 patients
Phase 1/2Completed
NCT05552261DompéCenegemin in the DEFENDO Study

DEFENDO Long Term Follow-up Study in Stage 1 NK Patients

Start: Feb 2023Est. completion: Apr 202424 patients
N/ACompleted
NCT04627571Angeles TherapeuticsCenegermin Ophthalmic Solution [Oxervate]

Corneal Nerves After Treatment With Cenegermin

Start: May 2022Est. completion: Mar 20258 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 actively recruiting trials targeting 602 patients
7 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.