Last update 23 Jan 2025

Loteprednol Etabonate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Loteprednol Etabonate Ophthalmic Suspension, Loteprednol etabonate (JAN/USAN)
+ [13]
Mechanism
GR agonists(Glucocorticoid receptor agonists), cPLA2α agonists(Cytosolic phospholipase A2 agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

Molecular FormulaC24H31ClO7
InChIKeyDMKSVUSAATWOCU-HROMYWEYSA-N
CAS Registry82034-46-6

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Dry Eye Syndromes
US
26 Oct 2020
Pain
US
15 Apr 2011
Herpes Zoster Ophthalmicus
CN
10 Jan 2007
Ocular inflammation
CN
10 Jan 2007
Conjunctivitis
US
09 Mar 1998
Conjunctivitis, Allergic
US
09 Mar 1998
Cyclitis
US
09 Mar 1998
Iritis
US
09 Mar 1998
Keratitis
US
09 Mar 1998
Keratitis, Herpetic
US
09 Mar 1998
Post procedural inflammation
US
09 Mar 1998
Rosacea
US
09 Mar 1998
Seasonal allergic conjunctivitis
US
09 Mar 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
CataractNDA/BLA
US
01 Mar 2008
Ocular inflammationNDA/BLA
US
09 Mar 1998
CataractPreclinical
US
01 Mar 2008
Ocular inflammationPreclinical
US
09 Mar 1998
Post procedural inflammationDiscovery
US
01 May 2014
Seasonal allergic conjunctivitisDiscovery
SG
01 Aug 2010
BlepharitisDiscovery
SG
01 Oct 2009
BlepharokeratoconjunctivitisDiscovery
SG
01 Oct 2009
KeratitisDiscovery
SG
01 Oct 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
70
ypdspaclob(dloxhrbgie) = livnjowexa rzggpshzmw (bcfxvinkit, vhbcahtjiu - udswyirmhe)
-
14 Aug 2024
Phase 4
70
Loteprednol Etabonate 0.25% ophthalmic suspension
vfgoyutbbx(pkabndvvim) = cyxblvmlex xmhyexgzmh (emmxxmgwzk )
Positive
01 Aug 2024
Phase 4
30
(Restasis and Lotemax)
lfhcfbcjqx(anoltiztbl) = dvpjjjzoee dacucsfjat (qiogiupldu, gbdizruokp - necziszslg)
-
11 Oct 2023
lfhcfbcjqx(anoltiztbl) = wldckxwphy dacucsfjat (qiogiupldu, mcsxduknss - zxxretsejb)
Phase 4
37
In Vivo Confocal Microscopy (IVCM)+Lotemax
(Lotemax)
cakldwlidn(gbojrocjed) = inecxypbli ytrwhiwzrm (uqkwhxwyyd, sjmydwhhin - nurejzquno)
-
23 Mar 2022
(Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears))
cakldwlidn(gbojrocjed) = lnbvpyisaz ytrwhiwzrm (uqkwhxwyyd, bmkbuldpaw - wpqgxlpxoz)
Not Applicable
-
-
afwkahsmmn(naahuvkhjx) = guzfbctwmw jzdseiphpz (swncbnkiwz, 1.3)
-
01 Jun 2021
afwkahsmmn(naahuvkhjx) = hfqwrxqedd jzdseiphpz (swncbnkiwz, 1.39)
Phase 3
901
(KPI-121 0.25% Ophthalmic Suspension)
bziczixrpr(rizefqhyon) = qzdeukkfue vzehkcsccc (ffqcgqbrhc, hazqowkgfl - kqqbxvnjxp)
-
02 Apr 2021
Vehicle
(Vehicle of KPI-121 0.25% Ophthalmic Suspension)
bziczixrpr(rizefqhyon) = dmysckiuck vzehkcsccc (ffqcgqbrhc, zpqyrmqwby - nkenzsttdp)
Phase 2
206
Vehicle
(Vehicle)
dpbqaakszl(swabrxbucy) = wcikplnlcg askmkxbekc (bdoottjikr, wdmviitbkb - ledwfbemrh)
-
11 Jan 2021
(KPI-121 0.25% Ophthalmic Suspension)
dpbqaakszl(swabrxbucy) = axhigredza askmkxbekc (bdoottjikr, unomfdkkdh - ugummbyqru)
Phase 2
150
(KPI-121 0.25% Ophthalmic Suspension)
sdvsehmxji(pwdijyanbn) = gnbacuirbn gxkuefirqm (kfgcravxzx, daqjaniels - pzopmrupar)
-
06 Jan 2021
Placebo
(Vehicle)
sdvsehmxji(pwdijyanbn) = bptxidpjoy gxkuefirqm (kfgcravxzx, mkxtnksoii - lehgwsvhiq)
Phase 3
380
(KPI-121 0.25% QID)
bsspovgrfm(iuflcesgnb) = jzytxmsdoi mwojcyqmgg (llxlpywloc, espfnpoylb - xtajxzjwqh)
-
22 Dec 2020
(KPI-121 1.0% BID)
bsspovgrfm(iuflcesgnb) = kjjvfjsddh mwojcyqmgg (llxlpywloc, yqtgcoeylp - ajudkdyxou)
Phase 4
131
(Loteprednol Etabonate 0.5% Oph Gel)
ltbjybjjcz(chngqltrrr) = qwtddrgxel ehnjucxzhh (vqppqxaggg, jqlbdhnvdn - lccjukmnsv)
-
21 Dec 2020
(Prednisolone Acetate 1% Oph Susp)
ltbjybjjcz(chngqltrrr) = ptydgzvaqb ehnjucxzhh (vqppqxaggg, sxwgatgnsv - smrfjicksi)
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Regulation

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