Nepafenac
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2005
- First approval year
- 2005
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Nepafenac
- Molecular weight
- 254.29
- Structure (SMILES)
- NC(=O)Cc1cccc(C(=O)c2ccccc2)c1N
- ilevro
- Ilevro
- nevanac
- Nevanac
- ahr 9434
- AHR-9434
- al 6515
- AL-6515
- dexamethasone sodium phosphate nepafenac
- ilevro
- Ilevro
- Ilevro (nepafenac 0.3%)
- nepafenac
- Nepafenac
- Nepafenac (Nevanac)
- NEPAFENAC [EMA EPAR]
- nepafenac [INN]
- NEPAFENAC [JAN]
- NEPAFENAC [MART.]
- NEPAFENAC [MI]
- NEPAFENAC [ORANGE BOOK]
- NEPAFENAC [USAN]
- NEPAFENAC [USP-RS]
- NEPAFENAC [VANDF]
- Nepafenac [WHO-DD]
- nepafenac ema epar
- nepafenac inn
- nepafenac jan
- nepafenac mart
And 12 more, listed on the interactive page.
- ATC classification codes
- S01BC10
Sources for recorded values
- CAS registry numbers
- 78281-72-8
- ChEMBL ID
- CHEMBL1021
- InChIKey
- QEFAQIPZVLVERP-UHFFFAOYSA-N
- PubChem compound IDs
- 151075
- RxNorm IDs (RxCUI)
- 298665
- FDA ingredient codes (UNII)
- 0J9L7J6V8C
- Applicant
- HARROW EYE
- Approval date
- 19 Aug 2005
- Application number
- NDA021862
- Status
- Authorised
- Status date
- 11 Dec 2007
- Authorisation date
- 11 Dec 2007
- Approved indications
- Nevanac is indicated for: prevention and treatment of postoperative pain and inflammation associated with cataract surgery; reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.
- Product number
- EMEA/H/C/000818
- Authorisation holder
- Novartis Europharm Limited
- 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
- No
- Exceptional circumstances
- No
Therapeutic areas
- Ophthalmologic Surgical Procedures
- Pain, Postoperative
European medicines record
- Patents
- 3
- Designations
- 1
- Earliest recorded loss of exclusivity
- 31 Mar 2032
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- nepafenac
- Type
- Synthetic organic
- Drug name stem
- -ac
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- topical
- Mechanism
- Cyclooxygenase inhibitor
- Action type
- Inhibitor
- Target
- Cyclooxygenase
- Protein identifier
- P23219
- Mechanism
- Cyclooxygenase inhibitor
- Action type
- Inhibitor
- Target
- Cyclooxygenase
- Protein identifier
- P35354
Open Targets mechanisms
- Mechanism
- Cyclooxygenase inhibitor
- Action type
- Inhibitor
- Target
- Cyclooxygenase
- Action type
- Inhibitor
- Gene symbol
- PTGS1
- Protein identifier
- P23219
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- PTGS2
- Protein identifier
- P35354
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Ophthalmologic Surgical Procedures
- Highest recorded phase
- 4
- Subject identifier
- D013508
- Condition
- Pain, Postoperative
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003843
- Subject identifier
- D010149
- Condition
- Eye Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005752
- Subject identifier
- D005128
- Condition
- Miosis
- Highest recorded phase
- 2
- Condition identifier
- HP:0000616
- Subject identifier
- D015877
- Condition
- Macular Edema
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0003005
- Subject identifier
- D008269
- Condition
- Cataract
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0005129
- Subject identifier
- D002386
- Condition
- Inflammation
- Highest recorded phase
- 4
- Condition identifier
- MP:0001845
- Subject identifier
- D007249
- Condition identifier
- EFO_0005752
- Condition identifier
- EFO_0005752
- Highest recorded phase
- 4
- Condition identifier
- EFO_0009321
- Highest recorded phase
- 3
- Condition identifier
- HP_0012531
- Highest recorded phase
- 2
- Condition identifier
- HP_0012531
- Highest recorded phase
- 3
- Condition identifier
- HP_0200026
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0003005
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004728
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005129
- Condition identifier
- MONDO_0005129
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005178
- Condition identifier
- MONDO_0005178
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005266
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006668
- Highest recorded phase
- 2
- Condition identifier
- MP_0001845
- Condition identifier
- MP_0001845
- Highest recorded phase
- 4
- Event
- anterior chamber cell
- Reports
- 6
- Reporting signal score
- 23.8121
- Event
- anterior chamber fibrin
- Reports
- 2
- Reporting signal score
- 8.68664
- Event
- anterior chamber flare
- Reports
- 4
- Reporting signal score
- 18.6694
- Event
- anterior chamber inflammation
- Reports
- 13
- Reporting signal score
- 63.2235
- Event
- cataract subcapsular
- Reports
- 3
- Reporting signal score
- 10.6686
- Event
- choroidal effusion
- Reports
- 3
- Reporting signal score
- 9.62583
- Event
- conjunctival hyperaemia
- Reports
- 5
- Reporting signal score
- 12.2633
- Event
- conjunctival oedema
- Reports
- 5
- Reporting signal score
- 17.9609
- Event
- corneal abrasion
- Reports
- 7
- Reporting signal score
- 29.3218
- Event
- corneal decompensation
- Reports
- 2
- Reporting signal score
- 8.96257
- Event
- corneal disorder
- Reports
- 16
- Reporting signal score
- 67.8133
- Event
- corneal epithelium defect
- Reports
- 22
- Reporting signal score
- 122.237
- Event
- corneal epithelium disorder
- Reports
- 9
- Reporting signal score
- 64.0227
- Event
- corneal erosion
- Reports
- 8
- Reporting signal score
- 38.6284
- Event
- corneal infiltrates
- Reports
- 9
- Reporting signal score
- 44.8706
- Event
- corneal oedema
- Reports
- 21
- Reporting signal score
- 86.5744
- Event
- corneal opacity
- Reports
- 32
- Reporting signal score
- 166.854
- Event
- corneal perforation
- Reports
- 8
- Reporting signal score
- 36.8643
- Event
- corneal scar
- Reports
- 10
- Reporting signal score
- 52.0668
- Event
- corneal thinning
- Reports
- 4
- Reporting signal score
- 18.4795
- Event
- cystoid macular oedema
- Reports
- 26
- Reporting signal score
- 119.252
- Event
- diarrhoea
- Reports
- 2
- Reporting signal score
- 13.6649
- Event
- dry eye
- Reports
- 10
- Reporting signal score
- 15.1966
- Event
- dyspnoea
- Reports
- 4
- Reporting signal score
- 7.79034
- Event
- endophthalmitis
- Reports
- 18
- Reporting signal score
- 56.469
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- Dose
- 1 drop
- Route
- Topical
- How often
- Once daily
- Additional drop 30-120 minutes prior to surgery
- Apply to affected eye
- Begin 1 day prior to surgery
- Continue through first 2 weeks post-op
- Hydrogen bond acceptors
- 3
- Hydrogen bond donors
- 2
- Polar surface area
- 86.18
- Calculated partition coefficient (ALogP)
- 1.53
- Calculated partition coefficient (XLogP)
- 1.9
- Prodrug
- Yes
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 4
- Heavy atoms
- 19
- Molecular formula
- C15H14N2O2
- Monoisotopic mass
- 254.105527694
- Natural product
- Yes
- 0078-0743
- 82667-400
- 82667-500
- Recorded assays
- 686
- Active assays
- 8
Active assay types
- Confirmatory
- Anti-Inflammatory Agents, Non-Steroidal
Related records
Trials (1,016)
- 1.Comparison of the Analgesic Effect of Remifentanil Group and Different Dose Groups of Oliceridine in Postoperative Patients Undergoing Cardiac Surgery 2.Exploring the Hemodynamic Effects of Analgesic Regimens With Different Doses of Oliceridine After Cardiac Surgery
- 14-day Double Therapy Versus Bismuth Quadruple Therapy in First-line Treatment of Helicobacter Pylori Infection
- 3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia
- 5-HTP and Creatine for Depression R33 Phase
- 7-day High-Dose Vonoprazan-amoxicillin Dual Therapy Versus 14-day Vonoprazan-amoxicillin Dual Therapy for H. Pylori
- A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
- A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
- A Clinical Study of Mesenchymal Stem Cell Exosomes Nebulizer for the Treatment of ARDS
- A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors
- A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
- A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis
- A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
- A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
- A Clinical Trial to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis.
- A Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants in China
- A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubricant Versus a Lubricant Alone in the Treatment of Epiphora Associated With Lacrimal Punctum Stenosis
- A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block
- A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
- A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
- A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief
Approved for (2)
- Cataract
- Eye disorder
In development for (2)
- Diabetic macular edema Phase 3
- Macular retinal edema Phase 2