Cenegermin
Highest phase reached
Approved
Drug type
Protein
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Cenegermin
- oxervate
- Oxervate
- 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
- CAS registry numbers
- 1772578-74-1
- ChEMBL ID
- CHEMBL4297852
- FDA ingredient codes (UNII)
- B6E7K36KT8
- S01
- S01XA24
Sources for recorded values
- 2104331
- 2104332
- Applicant
- DOMPE FARMACEUTICI
- Approval date
- 22 Aug 2018
- Application number
- BLA761094
- 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
- 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 name
- NGF
- Type
- Peptide
- Drug name stem
- -ermin
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- topical
- 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
- 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
- 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
- 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.
- NCT02855450
- NCT05133180
- NCT05136170
- Dose
- 1 drop
- Route
- Eye drops
- How often
- Six times daily at 2-hour intervals for eight weeks
- Remove contact lenses before use
- Wait 15 minutes before reinserting contact lenses after application
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 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.
- 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 Phase 3
- Glaucoma Phase 1