Cenegermin

Summary

Cenegermin (CHEMBL4297852) is an approved protein (ATC S01XA24) targeting NGFR; indicated across 4 conditions including keratitis and eye disorder.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: S01XA24
• Targets: 1 (NGFR)
• Indications: 4 conditions
• Clinical trials: 20

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297852
Name	Cenegermin
Type	Protein
Max phase	4
ATC	S01XA24

Also known as: Cenegermin, Cenegermin bkbj, Cenegermin-bkbj, Oxervate, Recombinant human nerve growth factor, Rhngf, CENEGERMIN

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
NGFR	nerve growth factor receptor		6	3.4%	P08138

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): NGFR.

Top Reactome pathways

11 total, by targets touching each:

Pathway	Targets	Genes
Axonal growth inhibition (RHOA activation)	1	NGFR
NRAGE signals death through JNK	1	NGFR
p75NTR negatively regulates cell cycle via SC1	1	NGFR
Ceramide signalling	1	NGFR
Regulated proteolysis of p75NTR	1	NGFR
NFG and proNGF binds to p75NTR	1	NGFR
NADE modulates death signalling	1	NGFR
NRIF signals cell death from the nucleus	1	NGFR
p75NTR recruits signalling complexes	1	NGFR
NF-kB is activated and signals survival	1	NGFR
Axonal growth stimulation	1	NGFR

Dominant GO biological processes

GO term	Targets
intracellular glucose homeostasis	1
intracellular protein transport	1
Rho protein signal transduction	1
axon guidance	1
central nervous system development	1
fibroblast growth factor receptor signaling pathway	1
detection of temperature stimulus	1
nerve development	1
negative regulation of cell migration	1
hair follicle morphogenesis	1
circadian regulation of gene expression	1
dorsal aorta development	1
negative regulation of fibroblast growth factor receptor signaling pathway	1
odontogenesis of dentin-containing tooth	1
positive regulation of odontogenesis of dentin-containing tooth	1

Indications & clinical

Indications

4 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
keratitis	4	MONDO:0003085	EFO:0009449
eye disorder	4	MONDO:0005328	EFO:0003966
dry eye syndrome	3	MONDO:0006733	EFO:1000906
glaucoma	1	MONDO:0005041	MONDO:0005041

Clinical trials

Total trials: 20.

Phase distribution

Phase	Trials
PHASE2	6
PHASE3	4
PHASE1	4
Not specified	3
PHASE1/PHASE2	2
PHASE4	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04485546	PHASE4	COMPLETED	Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis
NCT07453888	PHASE3	NOT_YET_RECRUITING	Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
NCT07519902	PHASE3	NOT_YET_RECRUITING	An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
NCT05133180	PHASE3	COMPLETED	Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren’s Dry Eye Disease (PROTEGO-1 Study)
NCT05136170	PHASE3	COMPLETED	Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren’s Dry Eye Disease
NCT01756456	PHASE1/PHASE2	COMPLETED	Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.
NCT02101281	PHASE2	COMPLETED	Safety and Efficacy of rhNGF Eye Drops at Different Doses in Patients With Dry Eye
NCT02110225	PHASE1/PHASE2	COMPLETED	A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP)
NCT02227147	PHASE2	COMPLETED	Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK
NCT02609165	PHASE2	COMPLETED	Nerve Growth Factor Eye Drops Treatment in Patients With Retinitis Pigmentosa and Cystoid Macular Edema
NCT03035864	PHASE2	COMPLETED	A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery
NCT03982368	PHASE2	COMPLETED	A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye
NCT06244316	PHASE2	COMPLETED	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.
NCT01744704	PHASE1	COMPLETED	Study to Evaluate Safety, Tolerability and Pharmacokinetics of rhNGF Eye Drops in Healthy Volunteers
NCT02855450	PHASE1	COMPLETED	Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma
NCT03836859	PHASE1	COMPLETED	Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers
NCT05700864	PHASE1	WITHDRAWN	NGF Treatment for Patients With Neuropathic Corneal Pain
NCT04293549	Not specified	COMPLETED	An 8-week Follow-up to Evaluate the Renewal of Corneal Nerves Structure and Function in Patients With Neurotrophic Keratopathy Treated With Recombinant Human Nerve Growth Factor (rhNGF) Eyedrops
NCT04552730	Not specified	COMPLETED	Nerve Growth Factor for the Treatment of Cornea Disease
NCT04573647	Not specified	UNKNOWN	OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).