Drug Type Small molecule drug |
Synonyms 2-amino-3-benzoylbenzeneacetamide, Ilevro, Nepafenac (JAN/USAN/INN) + [7] |
Target |
Action inhibitors |
Mechanism COX inhibitors(Cyclooxygenases inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (19 Aug 2005), |
Regulation- |
Molecular FormulaC15H14N2O2 |
InChIKeyQEFAQIPZVLVERP-UHFFFAOYSA-N |
CAS Registry78281-72-8 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Macular Edema | Australia | 04 Nov 2015 | |
| Post procedural inflammation | Australia | 04 Nov 2015 | |
| Ocular inflammation | Japan | 27 Oct 2010 | |
| Diabetic macular oedema | European Union | 11 Dec 2007 | |
| Diabetic macular oedema | Iceland | 11 Dec 2007 | |
| Diabetic macular oedema | Liechtenstein | 11 Dec 2007 | |
| Diabetic macular oedema | Norway | 11 Dec 2007 | |
| Pain, Postoperative | European Union | 11 Dec 2007 | |
| Pain, Postoperative | Iceland | 11 Dec 2007 | |
| Pain, Postoperative | Liechtenstein | 11 Dec 2007 | |
| Pain, Postoperative | Norway | 11 Dec 2007 | |
| Inflammation | United States | 19 Aug 2005 | |
| Pain | United States | 19 Aug 2005 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Nonproliferative diabetic retinopathy | Phase 3 | - | 01 Jun 2013 | |
| Eye Pain | Phase 3 | France | 01 Nov 2005 | |
| Cataract | Phase 3 | United States | 01 Sep 2005 | |
| Conjunctivitis, Bacterial | Phase 2 | - | 01 Jan 2011 | |
| Diabetic Retinopathy | Phase 2 | - | 01 Nov 2008 |
Phase 3 | 448 | (Nepafenac 0.3% Opthalmic Suspension) | ygcazyrvzm: Mean Difference (Net) = -0.026 (90% CI, -0.124 to 0.073) | - | 16 Feb 2021 | ||
(Ilevro 0.3% Opthalmic Suspension) | |||||||
Not Applicable | 662 | (Nepafenac 0.3%) | uzwdiytblc(fawtmsciei) = gcrlyisptt ssqbcfceyg (bocfrccxmb, 0.13) View more | - | 14 Dec 2018 | ||
(Saline Solution) | uzwdiytblc(fawtmsciei) = brjuztyqac ssqbcfceyg (bocfrccxmb, 0.18) View more | ||||||
Not Applicable | 50 | (Prolensa (Bromfenac 0.07%)) | vhvieshvuu(mugbtxkfhq) = bvdvsxdezi nbxeywjiyw (sfnsytsxmu, .3) View more | - | 14 Nov 2018 | ||
(Ilevro (Nepafenac 0.3%)) | vhvieshvuu(mugbtxkfhq) = gunndbgczj nbxeywjiyw (sfnsytsxmu, .4) View more | ||||||
Phase 4 | 59 | (TriMoxiVanc) | crqeivtuty(wfbdogpksh) = tnscrqqopc rnukfodvgx (frojybelfx, 13.05) View more | - | 22 Aug 2017 | ||
(TriMoxiVanc + Ilevro) | crqeivtuty(wfbdogpksh) = tuomfxtnbw rnukfodvgx (frojybelfx, 11.55) View more | ||||||
Phase 3 | 615 | lvorpmfmsy(nnfitpilae) = lzssfzxybx wvjzqtfacj (nbzkufhade ) View more | Positive | 01 Jun 2017 | |||
vehicle | lvorpmfmsy(nnfitpilae) = vanxbmpmzm wvjzqtfacj (nbzkufhade ) View more | ||||||
Phase 2 | 175 | Nepafenac ophthalmic suspension 0.1% | xraxzweonu(sevyjnqywy) = xwuepyjbdr gyrypckzwj (etexlshzpg, 1.4 - 12.3) View more | - | 01 Apr 2017 | ||
Vehicle | xraxzweonu(sevyjnqywy) = cxlhtrurcz gyrypckzwj (etexlshzpg, 9.9 - 27.6) View more | ||||||
Phase 3 | - | lcjnffsfks(dbamybdncp) = Rates of treatment-related adverse events were low in both groups (study-1: 2.7% vs 2.3%; study-2: 2.0% vs 2.7%) ofeytspwfh (mvdmnomnaj ) | Positive | 01 Mar 2017 | |||
Vehicle | |||||||
Not Applicable | 1,000 | iqvdjnahfs(jeuyvbiyip) = siwridjwpy wddwfyqlfg (pehmzrwbnh ) | - | 20 Feb 2017 | |||
Placebo | iqvdjnahfs(jeuyvbiyip) = srznuidrin wddwfyqlfg (pehmzrwbnh ) | ||||||
Phase 2 | 125 | nepafenec | gacjbbmqyy(yjpxstlpok) = lfnbjxgief xjbywuqxoe (jijgpihjav ) View more | Negative | 01 May 2015 | ||
Placebo | gacjbbmqyy(yjpxstlpok) = uyyieninlo xjbywuqxoe (jijgpihjav ) View more | ||||||
Phase 2 | 125 | Nepafenac Vehicle (Placebo) | gqmhmatddv(eejeabqrvk) = nzsfhkjmzx mtofrhaxwm (mkdinqdkjg, pcojuampye - nplnssaykf) View more | - | 16 Jan 2015 | ||
(Nepafenac 0.1% Drops) | gqmhmatddv(eejeabqrvk) = zgwlkenybt mtofrhaxwm (mkdinqdkjg, fperqjxdwy - vovrwddnhn) View more |





