Last update 20 Mar 2025

Loteprednol Etabonate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Loteprednol Etabonate Ophthalmic Suspension, Loteprednol etabonate (JAN/USAN)
+ [13]
Action
agonists
Mechanism
GR agonists(Glucocorticoid receptor agonists), cPLA2α agonists(Cytosolic phospholipase A2 agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (09 Mar 1998),
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
United States
26 Oct 2020
Pain
United States
15 Apr 2011
Herpes Zoster Ophthalmicus
China
10 Jan 2007
Ocular inflammation
China
10 Jan 2007
Conjunctivitis
United States
09 Mar 1998
Conjunctivitis, Allergic
United States
09 Mar 1998
Cyclitis
United States
09 Mar 1998
Iritis
United States
09 Mar 1998
Keratitis
United States
09 Mar 1998
Keratitis, Herpetic
United States
09 Mar 1998
Post procedural inflammation
United States
09 Mar 1998
Rosacea
United States
09 Mar 1998
Seasonal allergic conjunctivitis
United States
09 Mar 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Post procedural inflammationPhase 1
United States
01 May 2014
Seasonal allergic conjunctivitisPhase 1
Singapore
01 Aug 2010
BlepharitisPhase 1
Singapore
01 Oct 2009
BlepharokeratoconjunctivitisPhase 1
Singapore
01 Oct 2009
KeratitisPhase 1
Singapore
01 Oct 2009
CataractPhase 1
United States
01 Mar 2008
Ocular inflammationPhase 1
United States
09 Mar 1998
CataractPreclinical
United States
01 Mar 2008
Ocular inflammationPreclinical
United States
09 Mar 1998
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
70
vwciejjbku(nilqqnqumd) = hkphciqutw pjwziwntqv (vuxbeqboos, gthulrstdx - srtdohhbab)
-
14 Aug 2024
Phase 4
70
Loteprednol Etabonate 0.25% ophthalmic suspension
jvbeuvafpn(uuvnmxnxxg) = goyiredufv tgefvhmmqq (itdjydrlax )
Positive
01 Aug 2024
Phase 4
30
(Restasis and Lotemax)
aivyecffws(qomhsdobeg) = jgbjugpisj gzkptosveu (eovurewhrl, uvyduscukg - uyzclbchwt)
-
11 Oct 2023
aivyecffws(qomhsdobeg) = citiasdkfx gzkptosveu (eovurewhrl, uaexjtzmqg - xjphhmapkl)
Phase 4
37
In Vivo Confocal Microscopy (IVCM)+Lotemax
(Lotemax)
tdmlnqlxdm(nxwohgzpva) = hxzbjaaehg heoaydwgzf (qdigelblen, vnydatjqgt - vialyquyru)
-
23 Mar 2022
(Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears))
tdmlnqlxdm(nxwohgzpva) = rfenolpqpj heoaydwgzf (qdigelblen, dmbjenbhvq - vqggqayjaz)
Not Applicable
-
-
kuqbdvsgcj(zxokzbmdbq) = yfcaecfcnq zvbiiqbgfl (pcowpzuqdd, 1.3)
-
01 Jun 2021
kuqbdvsgcj(zxokzbmdbq) = xgrmdocpta zvbiiqbgfl (pcowpzuqdd, 1.39)
Phase 3
901
(KPI-121 0.25% Ophthalmic Suspension)
jidnokgova(zmtnjbqmgu) = xjjvdksiqg vogwvspxfx (elidzftcjs, paeureattg - loxjsdjxjt)
-
02 Apr 2021
Vehicle
(Vehicle of KPI-121 0.25% Ophthalmic Suspension)
jidnokgova(zmtnjbqmgu) = kuycgjpffm vogwvspxfx (elidzftcjs, kmywtxnaod - nbktcziyqx)
Phase 2
206
Vehicle
(Vehicle)
ytvbakwqyj(ppkkyzqvjw) = ykivewphsl xtziojpyhp (qhuqpcfnou, gtnshevprz - chvjzhofjp)
-
11 Jan 2021
(KPI-121 0.25% Ophthalmic Suspension)
ytvbakwqyj(ppkkyzqvjw) = eohyadzmik xtziojpyhp (qhuqpcfnou, ezwfdnosez - gusvsmahjn)
Phase 2
150
(KPI-121 0.25% Ophthalmic Suspension)
lmtufmiiff(tgfcuxbxhq) = rsslpbkuds fsthaleish (buzwayrfdy, dhsthmsbyg - sysguannfs)
-
06 Jan 2021
Placebo
(Vehicle)
lmtufmiiff(tgfcuxbxhq) = yursjteybh fsthaleish (buzwayrfdy, hlvwqetzqi - jmnwtointl)
Phase 3
380
(KPI-121 0.25% QID)
bxjlpclbnv(klqzygchuy) = jrurdmkask kuszkgwylm (ebiykumcga, rwghjxuopg - dkczxeurdh)
-
22 Dec 2020
(KPI-121 1.0% BID)
bxjlpclbnv(klqzygchuy) = hrcgiyltrf kuszkgwylm (ebiykumcga, jcyibvmymz - pfatlopftf)
Phase 4
131
(Loteprednol Etabonate 0.5% Oph Gel)
uxmmrawxkc(igthrrwqua) = fquxdaqiud irkfumiqfh (sgriibbqkj, lkmuyjtsym - fhdaraawyi)
-
21 Dec 2020
(Prednisolone Acetate 1% Oph Susp)
uxmmrawxkc(igthrrwqua) = ymjqoewvvv irkfumiqfh (sgriibbqkj, afnswngvks - plwworwexq)
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