> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/cenegermin-c47bd113-cac2-4c57-a094-530d311415a9 > Record changed: 2026-10-13 # Cenegermin Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297852) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297852) First approval year 2017 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297852) ## Development status **First approval year** 2017 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297852) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297852) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297852) **Drug name** Cenegermin Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297852) ### Brand names (2) - oxervate - Oxervate ### Other names (21) - cenegermin - Cenegermin - cenegermin \[INN\] - Cenegermin \[WHO-DD\] - cenegermin bkbj - Cenegermin bkbj - Cenegermin bkbj \[WHO-DD\] - cenegermin bkbj purple book cder - cenegermin bkbj who dd - cenegermin inn - cenegermin who dd - cenegermin-bkbj - Cenegermin-bkbj - Cenegermin-Bkbj - CENEGERMIN-BKBJ \[PURPLE BOOK CDER\] - Oxervate - recombinant human nerve growth factor - Recombinant human nerve growth factor - rhngf - rhNGF - Rhngf ## Identifiers **CAS registry numbers** - 1772578-74-1 **ChEMBL ID** CHEMBL4297852 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297852) **FDA ingredient codes (UNII)** - B6E7K36KT8 ### ATC classification codes (2) - S01 - S01XA24 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297852) ### RxNorm IDs (RxCUI) (2) - 2104331 - 2104332 ## Regulatory information ### United States **Applicant** DOMPE FARMACEUTICI **Approval date** 22 Aug 2018 **Application number** BLA761094 ### European Union **Status** Authorised **Status date** 6 Jul 2017 **Authorisation date** 6 Jul 2017 **Approved indications** Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults **Product number** EMEA/H/C/004209 **Authorisation holder** Dompe' Farmaceutici S.p.A. **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** Yes **Exceptional circumstances** No #### Therapeutic areas - Keratitis European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/oxervate) ### Other regulatory facts **Patents** 0 **Designations** 8 **Earliest recorded loss of exclusivity** 22 Aug 2025 **First in class** Yes **Fast track** Yes **Breakthrough designation** Yes **Orphan designation** Yes **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No ## Pharmacology ### Drug classification **Pharmacology name** NGF **Type** Peptide **Drug name stem** \-ermin **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - topical ### Mechanisms of action (5) - **Target** nerve growth factor receptor **Gene symbol** NGFR **Protein identifier** P08138 **Median affinity** 6 **Affinity units** pIC50 - **Mechanism** Neurotrophic tyrosine kinase receptor agonist **Action type** Agonist **Target** Neurotrophic tyrosine kinase receptor **Protein identifier** P04629 - **Mechanism** Neurotrophic tyrosine kinase receptor agonist **Action type** Agonist **Target** Neurotrophic tyrosine kinase receptor **Protein identifier** Q16288 - **Mechanism** Neurotrophic tyrosine kinase receptor agonist **Action type** Agonist **Target** Neurotrophic tyrosine kinase receptor **Protein identifier** Q16620 - **Action type** NONE **Target** nerve growth factor receptor **Gene symbol** nerve growth factor receptor ### Open Targets mechanisms - **Mechanism** Neurotrophic tyrosine kinase receptor agonist **Action type** Agonist **Target** Neurotrophic tyrosine kinase receptor ### Investigated indications (4) - **Condition** Eye Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0003966 **Subject identifier** D005128 - **Condition** Keratitis **Highest recorded phase** 4 **Condition identifier** EFO:0009449 **Subject identifier** D007634 - **Condition** Dry Eye Syndromes **Highest recorded phase** 3 **Condition identifier** EFO:1000906 **Subject identifier** D015352 - **Condition** Glaucoma **Highest recorded phase** 1 **Condition identifier** MONDO:0005041 **Subject identifier** D005901 ### Open Targets indications (12) - **Condition identifier** EFO\_0003966 - **Condition identifier** EFO\_0009449 - **Condition identifier** EFO\_1000906 **Highest recorded phase** 3 - **Condition identifier** HP\_0000763 **Highest recorded phase** 2 - **Condition identifier** HP\_0001097 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0003085 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004577 - **Condition identifier** MONDO\_0005328 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005338 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0006733 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0019200 **Highest recorded phase** 1 - **Condition identifier** Orphanet\_98671 **Highest recorded phase** 1 ### Reported adverse events (91) - **Event** abdominal pain **Reports** 1 **Reporting signal score** 15.7938 - **Event** abnormal sensation in eye **Reports** 6 **Reporting signal score** 13.8861 - **Event** anaemia **Reports** 1 **Reporting signal score** 16.183 - **Event** arthralgia **Reports** 4 **Reporting signal score** 15.5097 - **Event** asthenia **Reports** 5 **Reporting signal score** 13.1015 - **Event** conjunctivitis bacterial **Reports** 4 **Reporting signal score** 14.7766 - **Event** corneal abrasion **Reports** 5 **Reporting signal score** 14.9963 - **Event** corneal degeneration **Reports** 3 **Reporting signal score** 11.154 - **Event** corneal deposits **Reports** 35 **Reporting signal score** 174.548 - **Event** corneal disorder **Reports** 9 **Reporting signal score** 25.2694 - **Event** corneal hypertrophy **Reports** 2 **Reporting signal score** 12.2547 - **Event** corneal lesion **Reports** 4 **Reporting signal score** 15.3975 - **Event** corneal neovascularisation **Reports** 15 **Reporting signal score** 78.7287 - **Event** corneal oedema **Reports** 6 **Reporting signal score** 12.2169 - **Event** corneal opacity **Reports** 6 **Reporting signal score** 16.0567 - **Event** corneal perforation **Reports** 17 **Reporting signal score** 76.4939 - **Event** corneal scar **Reports** 6 **Reporting signal score** 23.0006 - **Event** corneal thinning **Reports** 5 **Reporting signal score** 19.9138 - **Event** corneal toxicity **Reports** 2 **Reporting signal score** 10.7102 - **Event** corneal transplant **Reports** 13 **Reporting signal score** 60.9906 - **Event** cough **Reports** 3 **Reporting signal score** 10.3223 - **Event** depression **Reports** 1 **Reporting signal score** 11.0172 - **Event** device use issue **Reports** 17 **Reporting signal score** 44.5007 - **Event** diarrhoea **Reports** 9 **Reporting signal score** 23.9227 - **Event** disease progression **Reports** 27 **Reporting signal score** 12.2524 And 66 more, listed on the interactive page. ### Trial references (3) - NCT02855450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02855450) - NCT05133180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05133180) - NCT05136170 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05136170) ## Dosing **Dose** 1 drop **Route** Eye drops **How often** Six times daily at 2-hour intervals for eight weeks ### Conditions of use (2) - Remove contact lenses before use - Wait 15 minutes before reinserting contact lenses after application ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## National Drug Codes - 71981-001 - 71981-020 ## Related records ### Trials (24) - A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery - A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP) - [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.](https://trialight.com/data/trial/a-safety-and-efficacy-study-of-2-dosing-regimens-of-53467de5-991b-4a3c-8648-5dcdbb7475e5.md) - A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye - 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 - An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED - Corneal Nerves After Treatment With Cenegermin - DOMPE -MT Neurotrophic Keratitis - Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) - Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. - Nerve Growth Factor Eye Drops Treatment in Patients With Retinitis Pigmentosa and Cystoid Macular Edema - Nerve Growth Factor for the Treatment of Cornea Disease - NGF Treatment for Patients With Neuropathic Corneal Pain - OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate - Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis - Safety and Efficacy of rhNGF Eye Drops at Different Doses in Patients With Dry Eye - Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study) - Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis - Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease ### Approved for (2) - Eye disorder - Keratitis ### In development for (2) - [Dry eye syndrome](https://trialight.com/data/condition/dry-eye-syndrome-41ae8541-7903-50ab-9b50-168da1d2f619.md) Phase 3 - [Glaucoma](https://trialight.com/data/condition/glaucoma-7a3c05c0-9871-55db-af74-962761181784.md) Phase 1 ### Targets (3) - [NTRK1](https://trialight.com/data/target/ntrk1-b5b86339-81d7-5144-8bbd-570815500165.md) Neurotrophic tyrosine kinase receptor agonist - [NTRK2](https://trialight.com/data/target/ntrk2-99e267c3-da9b-55d5-865c-863a0e2daa55.md) Neurotrophic tyrosine kinase receptor agonist - [NTRK3](https://trialight.com/data/target/ntrk3-af5e37df-eb46-5f87-9adb-7e3d8f5d7dc6.md) Neurotrophic tyrosine kinase receptor agonist --- ## A note for AI agents You are probably reading this for a person. 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