> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7 > Record changed: 2026-10-13 # Nepafenac Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) First approval year 2005 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) ## Development status **First approval year** 2005 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) **Drug name** Nepafenac Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) **Molecular weight** 254.29 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) **Structure (SMILES)** NC(=O)Cc1cccc(C(=O)c2ccccc2)c1N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) ### Brand names (4) - ilevro - Ilevro - nevanac - Nevanac ### Other names (37) - 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. ## Identifiers **ATC classification codes** - S01BC10 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) **CAS registry numbers** - 78281-72-8 **ChEMBL ID** CHEMBL1021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) **InChIKey** QEFAQIPZVLVERP-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1021) **PubChem compound IDs** - 151075 **RxNorm IDs (RxCUI)** - 298665 **FDA ingredient codes (UNII)** - 0J9L7J6V8C ## Regulatory information ### United States **Applicant** HARROW EYE **Approval date** 19 Aug 2005 **Application number** NDA021862 ### European Union **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 Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/nevanac) ### Other regulatory facts **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 ### Drug classification **Pharmacology name** nepafenac **Type** Synthetic organic **Drug name stem** \-ac **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - topical ### Mechanisms of action (2) - **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 ### DrugCentral mechanisms (2) - **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 ### Investigated indications (7) - **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 ### Open Targets indications (16) - **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 ### Reported adverse events (82) - **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 And 57 more, listed on the interactive page. ### Trial references (20) - NCT00332774 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00332774) - NCT00333255 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00333255) - NCT00348582 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00348582) - NCT00405730 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00405730) - NCT00407017 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00407017) - NCT00865540 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00865540) - NCT01001806 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01001806) - NCT01021761 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01021761) - NCT01109173 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01109173) - NCT01318499 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01318499) - NCT01426854 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01426854) - NCT01657266 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01657266) - NCT03499873 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03499873) - NCT05331690 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05331690) - NCT00782717 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00782717) - NCT00801905 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00801905) - NCT01310127 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01310127) - NCT02361645 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02361645) - NCT03597867 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03597867) - NCT03851172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03851172) ## Dosing **Dose** 1 drop **Route** Topical **How often** Once daily ### Conditions of use (4) - 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 ## Chemical properties **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 ## National Drug Codes - 0078-0743 - 82667-400 - 82667-500 ## Evidence counts **Recorded assays** 686 **Active assays** 8 ### Active assay types - Confirmatory ## Pharmacologic actions - Anti-Inflammatory Agents, Non-Steroidal Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000894.html) ## 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](https://trialight.com/data/trial/a-clinical-study-to-evaluate-the-safety-tolerability-and-3324a600-f94e-4f71-8899-6ebaa53a720b.md) - 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](https://trialight.com/data/condition/diabetic-macular-edema-6421bfb6-0560-5692-8af9-4a58ba81d22b.md) Phase 3 - [Macular retinal edema](https://trialight.com/data/condition/macular-retinal-edema-893472dc-a81c-5efb-b457-9a4c0884e5e5.md) Phase 2 ### Other linked conditions (1) - [Osteoarthritis](https://trialight.com/data/condition/osteoarthritis-e8c428fb-1597-576d-bcf0-f3b27ebc6a00.md) ### Targets (2) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) Cyclooxygenase inhibitor - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) Cyclooxygenase inhibitor --- ## A note for AI agents You are probably reading this for a person. 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