Drugs / Nepafenac
Nepafenac
also known as
Nevanac · Ilevro · AHR-9434 · AL-6515 · IlevroTM · Nepafenac (Nevanac) · Nepafenac 0.3% Ophthalmic Suspension · Nepafenaco · +2 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Nevanac | — | 2007-12-11 | europa.eu ↗ |
| Approved | US (FDA) | NEVANAC | — | 2005-08-19 | fda.gov ↗ |
Trials 34 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 26 trials | ||||||
| Phase 2 | NCT04843839 | Dec 2020 → Dec 2022 | congenital hereditary endothelial dystrophy of cornea | L.V. Prasad Eye Institute | Unknown | No outcome recorded |
| Phase 2 | NCT03851172 | Mar → Dec 2019 | cataract | Assiut University | Unknown | No outcome recorded |
| Phase 2 | NCT03496467 | Mar → Dec 2018 | — | Mati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01318499 | Mar → Sep 2011 | cataract | Alcon Research | Completed | No outcome recorded |
| Phase 2 | NCT01238783 | Jan → Dec 2011 | bacterial conjunctivitis | Alcon Research | Withdrawn | No outcome recorded |
| Phase 2 | NCT00782717 | Nov 2008 → Jul 2010 | macular retinal edema | Alcon Research | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT03597867 | Apr → Jul 2018 | — | University of Trieste | Completed | No outcome recorded |
| Phase 3 | NCT03499873 | Mar → Oct 2018 | cataract | Actavis Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02361645 | Mar → Nov 2014 | hyalitis | University of Brescia | Completed | No outcome recorded |
| Phase 3 | NCT01872611 | Jun 2013 → May 2015 | cataract, diabetic retinopathy | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT01853072 | Jun 2013 → May 2015 | cataract, diabetic retinopathy | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT01109173 | Jun 2010 → May 2011 | cataract | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00939276 | Aug 2009 → May 2011 | diabetic retinopathy | Alcon Research | Terminated | No outcome recorded |
| Phase 3 | NCT00332774 | Feb → Dec 2006 | cataract | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00405730 | Nov 2005 → Jul 2006 | cataract | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00333255 | Sep 2005 → Mar 2006 | cataract | Alcon Research | Completed | No outcome recorded |
| Phase 416 trials | ||||||
| Phase 4 | NCT07276802 | Apr → Dec 2026 expected | cataract | Research Insight LLC | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07372014 | Jan → Mar 2026 overdue | excessive tearing, stenosis of lacrimal punctum | Instituto de Oftalmología Fundación Conde de Valenciana | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05072262 | Nov 2022 → Jun 2024 overdue | — | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07162818 | Apr → Dec 2021 | proliferative vitreoretinopathy, rhegmatogenous retinal detachment | Indonesia University | Completed | No outcome recorded |
| Phase 4 | NCT07696104 | Oct 2020 → May 2024 | cystoid macular edema | Pomeranian Medical University Szczecin | Completed | No outcome recorded |
| Phase 4 | NCT01939691 | Sep 2018 → Mar 2020 | macular retinal edema, uveitis | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 4 | NCT02084576 | Aug 2013 | cataract, cystoid macular edema | Hospital Oftalmologico de Brasilia | Completed | No outcome recorded |
| Phase 4 | NCT02443012 | Mar 2013 → Aug 2014 | diabetic macular edema | Universiti Sains Malaysia | Completed | No outcome recorded |
| Phase 4 | NCT01995890 | Dec 2012 → Feb 2013 | — | Dr T V Patel Eye Institute | Completed | No outcome recorded |
| Phase 4 | NCT00865540 | Mar 2009 → Aug 2011 | cataract | Clinica Oftamologica Zona Sul | Unknown | No outcome recorded |
| Phase 4 | NCT00818844 | Jan 2009 → Jun 2010 | preretinal fibrosis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00494494 | Jun 2007 → Apr 2008 | cystoid macular edema | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT00330798 | Feb → Jun 2006 | — | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00347204 | Jan → Jun 2006 | hyperopia, myopia | Center For Excellence In Eye Care | Completed | No outcome recorded |
| Phase 4 | NCT00377546 | — | — | Innovative Medical | Completed | No outcome recorded |
| Phase 4 | NCT00348582 | — | cataract | Innovative Medical | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02506348 | Jul 2015 → Jan 2016 | — | Wolfson Medical Center | Unknown | No outcome recorded |
| — | NCT03025945 | Oct 2013 → Jan 2017 | cystoid macular edema | Intuor Technologies, Inc. | Completed | No outcome recorded |
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT01657266 Comparator | Dec 2013 → Mar 2015 | cataract 50 with or without glaucoma | Laboratorios Sophia S.A de C.V. | Completed | No outcome recorded |
| Phase 2 | NCT01331005 Comparator | May 2011 → Dec 2013 | diabetic macular edema | Jaeb Center for Health Research | Completed | No outcome recorded |
| Phase 2 | NCT00801905 Comparator | Aug → Dec 2008 | macular retinal edema | Asociación para Evitar la Ceguera en México | Terminated | No outcome recorded |
| Phase 2 | NCT00900887 Comparator | Apr 2008 → Mar 2015 | diabetic retinopathy, macular retinal edema | Hospital Juarez de Mexico | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01426854 Comparator | Jul 2011 → Apr 2012 | cataract | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00780780 Comparator | Jul 2007 → Aug 2008 | diabetic macular edema | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT05331690 Comparator | Nov 2022 → Aug 2023 | cataract | Oslo University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05433428 Background | Aug 2020 → Jan 2023 | cataract, dry eye syndrome | Ifocus Oyeklinikk | Unknown | No outcome recorded |
| Phase 4 | NCT03918590 Comparator | Dec 2018 → May 2019 | diabetic macular edema, retinal vein occlusion, wet macular degeneration | The New York Eye & Ear Infirmary | Unknown | No outcome recorded |
| Phase 4 | NCT02515045 Comparator | Jan 2015 → Mar 2016 | cataract | Carolina Eyecare Physicians, LLC | Completed | No outcome recorded |
| Phase 4 | NCT03886779 Comparator | Oct 2013 → Feb 2017 | cataract | Silverstein Eye Centers | Completed | No outcome recorded |
| Phase 4 | NCT01310127 Comparator | Nov 2010 → Apr 2011 | — | Toyos Clinic | Completed | No outcome recorded |
| Phase 4 | NCT01395069 Comparator | Feb 2010 → May 2011 | macular retinal edema | Queen's University | Completed | No outcome recorded |
| Phase 4 | NCT01001806 Comparator | Oct → Dec 2009 | cataract | Frank A. Bucci, Jr., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT01021761 Comparator | Oct → Dec 2009 | cataract | Frank A. Bucci, Jr., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT00869219 Comparator | Mar → Aug 2009 | — | Santa Casa de Misericordia de Santos | Unknown | No outcome recorded |
| Phase 4 | NCT00828477 Comparator | Jan → Jun 2009 | — | Bp Consulting, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00407017 Background | — | cataract | Innovative Medical | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07178639 Comparator | Aug 2025 → Feb 2026 overdue | cataract, cystoid macular edema | Nemocnice Kolín | Recruiting | No outcome recorded |
| — | NCT03406689 Comparator | Sep 2017 → Feb 2018 | — | University Hospital of Patras | Completed | No outcome recorded |
| — | NCT02955641 Comparator | Nov 2016 → Nov 2018 | primary angle-closure glaucoma | Sheba Medical Center | Unknown | No outcome recorded |
| — | NCT02821390 Comparator | Jun 2016 → Jan 2017 | — | University Hospital of Patras | Completed | No outcome recorded |
| — | NCT02752646 Comparator | Apr 2016 → Mar 2017 | cataract | MDbackline, LLC | Completed | No outcome recorded |
| — | NCT01847638 Comparator | Apr 2013 → Jul 2016 | cataract, retinal edema | Melissa Toyos | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nepafenac | “Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye” NCT01657266 ↗53“Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery.” NCT02515045 ↗ “Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery” NCT03597867 ↗ “topical nepafenac 0.3% (Ilevro) for 14 days” NCT07276802 ↗ |
| Known as | AHR-9434 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1021 ↗ |
| Known as | AL-6515 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01238783 ↗ |
| Known as | Ilevro | “A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)” NCT03918590 ↗3“Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD” NCT03886779 ↗ “topical nepafenac 0.3% (Ilevro) for 14 days” NCT07276802 ↗ “Ilevro (nepafenac 0.3%)” NCT01847638 ↗ |
| Known as | IlevroTM | “with IlevroTM (Nepafenac Ophthalmic Suspension), 0.3% of Alcon Laboratories, Inc. for the Treatment of Pain and Inflammation Associated With Cataract Surgery.” NCT03499873 ↗ |
| Known as | Nepafenac (Nevanac) | “Nepafenac (Nevanac)” NCT00780780 ↗ |
| Known as | Nepafenac 0.3% Ophthalmic Suspension | “Nepafenac 0.3% Ophthalmic Suspension” NCT03597867 ↗ |
| Known as | Nepafenaco | ChEMBL registry synonym — accepted as the source's own label CHEMBL1021 ↗ |
| Known as | Nevanac | “Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery” NCT03597867 ↗8“Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)” NCT01021761 ↗ “Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery” NCT05331690 ↗ “Nevanac 3 mg /mL five days after surgery.” NCT05433428 ↗ “Topical nepafenac (Nevanac) 3 mg/ml” NCT05072262 ↗ “Nepafenac 0.1%, Nevanac ® Alcon ®” NCT00865540 ↗ “Nepafenac (Nevanac)” NCT00347204 ↗ |
| Known as | Nevanac (nepafenac ophthamic suspension) 0.1% | “Nevanac (nepafenac ophthamic suspension) 0.1%” NCT01310127 ↗ |
| Known as | NEVANAC 0.1% | “The study eye drops were nepavenac 0.1% eye drops (NEVANAC 0.1%®, Alcon Laboratories, Inc., Fort Worth, Texas).” NCT07162818 ↗ |
| Modality | Other / unclassified | “non-steroidal anti-inflammatory drug (NSAID) ophthalmic solution” PMID 16488953 ↗ Mar 2006 |
| Route | Topical | “Effects of topical nepafenac on corneal epithelial healing time” PMID 18500088 ↗ Apr 2008 |