Last update 15 Apr 2025

Epinastine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Epinastine, Epinastine hydrochloride (JAN), エピナスチン
+ [13]
Action
antagonists
Mechanism
H1 receptor antagonists(Histamine H1 receptor antagonists)
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Structure/Sequence

Molecular FormulaC16H16ClN3
InChIKeyVKXSGUIOOQPGAF-UHFFFAOYSA-N
CAS Registry108929-04-0

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Conjunctivitis, Allergic
Japan
20 Sep 2013
Seasonal allergic conjunctivitis
Austria
04 Mar 2003
Seasonal allergic conjunctivitis
Belgium
04 Mar 2003
Seasonal allergic conjunctivitis
Czechia
04 Mar 2003
Seasonal allergic conjunctivitis
Denmark
04 Mar 2003
Seasonal allergic conjunctivitis
France
04 Mar 2003
Seasonal allergic conjunctivitis
Germany
04 Mar 2003
Seasonal allergic conjunctivitis
Greece
04 Mar 2003
Seasonal allergic conjunctivitis
Hungary
04 Mar 2003
Seasonal allergic conjunctivitis
Ireland
04 Mar 2003
Seasonal allergic conjunctivitis
Italy
04 Mar 2003
Seasonal allergic conjunctivitis
Luxembourg
04 Mar 2003
Seasonal allergic conjunctivitis
Netherlands
04 Mar 2003
Seasonal allergic conjunctivitis
Poland
04 Mar 2003
Seasonal allergic conjunctivitis
Portugal
04 Mar 2003
Seasonal allergic conjunctivitis
Slovakia
04 Mar 2003
Seasonal allergic conjunctivitis
Spain
04 Mar 2003
Seasonal allergic conjunctivitis
Sweden
04 Mar 2003
Seasonal allergic conjunctivitis
United Kingdom
04 Mar 2003
Psoriasis
China
16 Jun 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Rhinitis, Allergic, SeasonalPhase 3-18 Dec 2007
Dermatitis, AtopicPhase 3-01 Jun 2001
Rhinitis, Allergic, PerennialPhase 3-01 May 2000
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
87
Epinastine (DE-114)
(Epinastine (DE-114) Ophthalmic Solution)
pnnpgfpvsb(cvrgtqacwd) = upxnylfamy ytplvtsysh (rceprladvi, 0.1)
-
05 Nov 2014
Placebo
(Placebo Ophthalmic Solution)
pnnpgfpvsb(cvrgtqacwd) = gvlvfpnglg ytplvtsysh (rceprladvi, 0.1)
Phase 3
130
kznogzvuor(iielpcvocr) = rwmorcrmut fjgxzyifuc (mvmuyapkjx, 0.1)
-
23 Sep 2014
Phase 4
79
(Elestat)
ueokawwats(dpteidmpyc) = ghmfwmkpnr qomdutctcl (icegmzaufe, 1.36)
-
27 May 2009
(Pataday)
ueokawwats(dpteidmpyc) = mcybjswdlf qomdutctcl (icegmzaufe, 1.07)
Not Applicable
99
Epinastine HCl 0.05%
ctctkbwkti(vvxxnvxexn) = Three (5.9%) epinastine patients and 7 (14.6%) ketotifen patients experienced adverse events. Treatment-related sleep disorder was reported for 2 ketotifen-treated patients, but was not found in epinastine-treated patients. fahmuirweo (jzqvzyrdel )
-
01 May 2004
Not Applicable
-
-
Epinastine HCl 0.05%
mzsusujbjt(alphqbuzge) = primarily colds/URI, was the most frequent AE reported in 5.0% of epinastine subjects and 8.3% of vehicle subjects mlhgbfgdfv (uukuisddyp )
Positive
01 May 2003
Vehicle
Not Applicable
14
vgpvhhuryg(pptoveiaoe) = No adverse events nor any clinically relevant changes in visual acuity, biomicroscopy, ophthalmoscopy, vital signs, physical examination, or laboratory parameters were observed during the study xrlvpiaqhj (rrwimyhysf )
Positive
01 May 2003
Not Applicable
-
Epinastine HCl 0.05%
birqajxgxp(mfmwkvegji) = hyxhlvlwzm zdtgndvzrb (icjanductd )
Positive
01 May 2003
birqajxgxp(mfmwkvegji) = floyfkkbkc zdtgndvzrb (icjanductd )
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Approval

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Regulation

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