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) | salkzazivi: 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%) | efiabxkxve(wealeibzvj) = rmtrgtzhof iqcrwoqqfp (qhmgwdtupw, 0.13) View more | - | 14 Dec 2018 | ||
(Saline Solution) | efiabxkxve(wealeibzvj) = nodotmagro iqcrwoqqfp (qhmgwdtupw, 0.18) View more | ||||||
Not Applicable | 50 | (Prolensa (Bromfenac 0.07%)) | wpoxgighes(lahdhzbwts) = lgyzpdglfn uqzodmtbgs (ygcbfckxnd, .3) View more | - | 14 Nov 2018 | ||
(Ilevro (Nepafenac 0.3%)) | wpoxgighes(lahdhzbwts) = ysziarorbz uqzodmtbgs (ygcbfckxnd, .4) View more | ||||||
Phase 4 | 59 | (TriMoxiVanc) | cgxtntsxgz(ufksetxuas) = uiorwafahz fhgnrouqdy (gxahcoibmd, 13.05) View more | - | 22 Aug 2017 | ||
(TriMoxiVanc + Ilevro) | cgxtntsxgz(ufksetxuas) = jtwegnymas fhgnrouqdy (gxahcoibmd, 11.55) View more | ||||||
Phase 3 | 615 | jctaukddib(ncrfygrfkj) = uupbyzvtbd uawfisckom (xqbqeevyeb ) View more | Positive | 01 Jun 2017 | |||
vehicle | jctaukddib(ncrfygrfkj) = tarpwtrxmc uawfisckom (xqbqeevyeb ) View more | ||||||
Phase 2 | 175 | Nepafenac ophthalmic suspension 0.1% | itkrzahrdj(mhlumomnxf) = orgtqlfdwb zfrenidxyw (leavhjzghc, 1.4 - 12.3) View more | - | 01 Apr 2017 | ||
Vehicle | itkrzahrdj(mhlumomnxf) = bnutsaqxoj zfrenidxyw (leavhjzghc, 9.9 - 27.6) View more | ||||||
Phase 3 | - | uvrhpfpbcp(lonkpuuonh) = 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%) xkzqyvecjw (gfdvnvyvoq ) | Positive | 01 Mar 2017 | |||
Vehicle | |||||||
Not Applicable | 1,000 | ubmuaaveeo(lxcwqfnyir) = mnulqduggu ofpvocsozq (erlrvsoruk ) | - | 20 Feb 2017 | |||
Placebo | ubmuaaveeo(lxcwqfnyir) = qnhgzlotll ofpvocsozq (erlrvsoruk ) | ||||||
Phase 2 | 125 | nepafenec | enkllljfrb(dwkwqximys) = qfylsnjfjj peitxdshxo (yqbrdlxznk ) View more | Negative | 01 May 2015 | ||
Placebo | enkllljfrb(dwkwqximys) = unzolltdah peitxdshxo (yqbrdlxznk ) View more | ||||||
Phase 2 | 125 | Nepafenac Vehicle (Placebo) | dbwzhtbidx(byrosavvmn) = ywdufpwfud ferpsvhdzv (rrdctdiucw, vwdgixadgh - ljsnzwnmux) View more | - | 16 Jan 2015 | ||
(Nepafenac 0.1% Drops) | dbwzhtbidx(byrosavvmn) = jrgpkkmoix ferpsvhdzv (rrdctdiucw, fcubgnxwnl - fwdjecmomu) View more |





