Nepafenac

Summary

Nepafenac (CHEMBL1021) is an approved small-molecule prodrug (ATC S01BC10); indicated across 7 conditions including eye disorder and cataract.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: S01BC10
• Indications: 7 conditions
• Clinical trials: 45
• Chemistry: 254.28 Da · C15H14N2O2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1021
Name	Nepafenac
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	151075
ChEBI	CHEBI:75922
ATC	S01BC10
Molecular formula	C15H14N2O2
Molecular weight	254.28
InChIKey	QEFAQIPZVLVERP-UHFFFAOYSA-N

SMILES: C1=CC=C(C=C1)C(=O)C2=CC=CC(=C2N)CC(=O)N

IUPAC name: 2-(2-amino-3-benzoylphenyl)acetamide

ChEBI definition: A monocarboxylic acid amide that is amfenac in which the carboxylic acid group has been converted into the corresponding carboxamide. It is a prodrug for amfenac, used in eye drops to treat pain and inflammation following cataract surgery.

Pharmacological roles (ChEBI): prodrug, cyclooxygenase 2 inhibitor, cyclooxygenase 1 inhibitor, non-steroidal anti-inflammatory drug, non-narcotic analgesic.

Also known as: AHR-9434, AL-6515, Ilevro, Nepafenac, Nepafenaco, Nevanac, NEPAFENAC, SID144206538, SID124896627, SID170465203, NepafenacÊ, NepafenacÂ

Patent coverage: 1,433 distinct patent families (5,891 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 5,798 (98%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

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

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
eye disorder	4	MONDO:0005328	EFO:0005752
cataract	4	MONDO:0005129	MONDO:0005129

5 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 45.

Phase distribution

Phase	Trials
PHASE4	24
PHASE2	8
PHASE3	7
Not specified	6

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05072262	PHASE4	RECRUITING	DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)
NCT07372014	PHASE4	ACTIVE_NOT_RECRUITING	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
NCT00330798	PHASE4	COMPLETED	A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief
NCT00347204	PHASE4	COMPLETED	Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK
NCT00348582	PHASE4	COMPLETED	Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery
NCT00377546	PHASE4	COMPLETED	Comparison of Vitreous Levels of Acular LS 0.04%, Xibrom 0.09%, and Nevanac 0.1%
NCT00407017	PHASE4	COMPLETED	Therapeutic Variables in Cataract Surgery
NCT00494494	PHASE4	COMPLETED	Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery
NCT00818844	PHASE4	COMPLETED	Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery
NCT00828477	PHASE4	COMPLETED	Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)
NCT00865540	PHASE4	UNKNOWN	Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
NCT00869219	PHASE4	UNKNOWN	Comparison of Pain Sensation During Single Use of Two Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
NCT01001806	PHASE4	COMPLETED	A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
NCT01021761	PHASE4	COMPLETED	A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
NCT01310127	PHASE4	COMPLETED	Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%
NCT01395069	PHASE4	COMPLETED	Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery
NCT01939691	PHASE4	TERMINATED	Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
NCT01995890	PHASE4	COMPLETED	Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes
NCT02084576	PHASE4	COMPLETED	Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification
NCT02515045	PHASE4	COMPLETED	Dropless vs. Standard Drops Contralateral Eye Study
NCT03886779	PHASE4	COMPLETED	Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial
NCT03918590	PHASE4	UNKNOWN	Post Intravitreal Injection Topical NSAID vs. Patching
NCT05331690	PHASE4	UNKNOWN	Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)
NCT07162818	PHASE4	COMPLETED	Effects of 0.1% Nepafenac on Vitreous Inflammatory Biomarkers in Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy
NCT00405730	PHASE3	COMPLETED	Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
NCT00780780	PHASE3	COMPLETED	Efficacy Study of Triamcinolone Associated With Nepafenac for Treatment of Diabetic Macular Edema
NCT01109173	PHASE3	COMPLETED	Confirmatory Study Nepafenac 0.3%
NCT01853072	PHASE3	COMPLETED	Nepafenac Once Daily for Macular Edema - Study 1
NCT02361645	PHASE3	COMPLETED	NSAIDs and PGE2 Levels in Vitrectomy Patients
NCT03499873	PHASE3	COMPLETED	Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension
NCT03597867	PHASE3	COMPLETED	PGE2 Levels in Patient Treated With NSAIDs
NCT00801905	PHASE2	TERMINATED	Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation
NCT00900887	PHASE2	COMPLETED	Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema
NCT01238783	PHASE2	WITHDRAWN	Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis
NCT01331005	PHASE2	COMPLETED	NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)
NCT01657266	PHASE2	COMPLETED	Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification
NCT03496467	PHASE2	COMPLETED	Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract
NCT03851172	PHASE2	UNKNOWN	Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery
NCT04843839	PHASE2	UNKNOWN	CHED - Congenital Hereditary Endothelial Dystrophy: New Paradigm Shift in Therapy Using Topical Eye Drops
NCT07178639	Not specified	RECRUITING	Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
NCT02506348	Not specified	UNKNOWN	Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort
NCT02752646	Not specified	COMPLETED	Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%
NCT02955641	Not specified	UNKNOWN	Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
NCT03025945	Not specified	COMPLETED	Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
NCT03406689	Not specified	COMPLETED	Comparison of the Efficacy of Nepafenac 0.1% and Nepafenac 0.3 % on Pain Associated With Intravitreal Injections

Clinical evidence (CIViC)

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

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

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