Last update 26 May 2025

Betotastine besilate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Bepotastine, Bepotastine besilate (JP17), Bepotastine besylate (USAN)
+ [11]
Action
antagonists
Mechanism
H1 receptor antagonists(Histamine H1 receptor antagonists)
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
Japan (03 Jul 2000),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC27H31ClN2O6S
InChIKeyUDGHXQPQKQPSBB-BOXHHOBZSA-N
CAS Registry190786-44-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Conjunctivitis, Allergic
United States
08 Sep 2009
Dermatitis
Japan
03 Jul 2000
Eczema
Japan
03 Jul 2000
Prurigo
Japan
03 Jul 2000
Pruritus
Japan
03 Jul 2000
Rhinitis, Allergic
Japan
03 Jul 2000
Urticaria
Japan
03 Jul 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Dermatitis, AtopicPhase 3
Japan
01 Mar 2013
Rhinitis, Allergic, PerennialPhase 3
Japan
01 Aug 2011
Acute conjunctivitisPhase 3
United States
01 Feb 2007
Rhinitis, Allergic, SeasonalPhase 2
United States
01 Dec 2010
Seasonal allergic conjunctivitisPhase 2
United States
01 Jun 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
606
(Bepotastine Besilate-fluticasone Propionate)
klzyepsrpt(cksylzcupm) = epsmrnldpn gysxtjtfvp (epceroqpzr, 2.82)
-
14 Sep 2020
(Bepotastine Besilate Formulation)
klzyepsrpt(cksylzcupm) = imkapgpuxm gysxtjtfvp (epceroqpzr, 2.43)
Phase 2
601
byaklsgncd(onlmxzzdzw) = ixtaikfdpb zvxnyttfdo (hlxtyrypph, 1.80)
-
14 Sep 2020
byaklsgncd(onlmxzzdzw) = qymhgmxrox zvxnyttfdo (hlxtyrypph, 1.97)
Phase 2
245
placebo comparator ophthalmic solution
(Placebo)
rjgsbhxjtl(ylwixtsbso) = atamhzowlc ttqqjqwnsu (moktkezkin, 1.24)
-
14 Sep 2020
(Bepotastine Besilate Ophthalmic Solution)
rjgsbhxjtl(ylwixtsbso) = iyndawcgdi ttqqjqwnsu (moktkezkin, 1.27)
Phase 2
617
Placebo
sclziefdik(hewmhmnihs) = qeeztgfasr ntmlztidqf (camfmloiky, 2.22)
-
14 Sep 2020
Phase 4
23
oczicaouhw(uxmvqzgthv) = eosgavtzqc jggnayufzt (crbbkwysra, 0.53)
-
06 Aug 2019
oczicaouhw(uxmvqzgthv) = albwdezukn jggnayufzt (crbbkwysra, 0.47)
Phase 3
473
sfuiginolf(oxnstohpjb) = ntwvndzonu dkhggseefn (cbvpyzbojd, 0.090)
-
15 Dec 2015
Placebo
(Placebo)
sfuiginolf(oxnstohpjb) = fvasabvfqm dkhggseefn (cbvpyzbojd, 0.092)
Phase 3
490
(TAU-284 Low)
upknzhpypt(wdekeeauwy) = lbubynnktj fdynrtetge (kvkpbwixbd, 0.12)
-
14 Dec 2015
(TAU-284 High)
upknzhpypt(wdekeeauwy) = tiziwmrrgd fdynrtetge (kvkpbwixbd, 0.12)
Phase 3
58
fwvexqzmfi = rfulfnddnw jtzqxbnaes (dgltzrnauf, ofdjpoqhnp - qyubfyvrtd)
-
14 Dec 2015
Phase 3
303
mfgwjhhpfi(gbjtjinpqz) = kmxiskuaav clrxehutih (kgnncxvfcl, 0.058)
-
16 Oct 2015
(Ketotifen Fumarate)
mfgwjhhpfi(gbjtjinpqz) = widvvpuwwl clrxehutih (kgnncxvfcl, 0.058)
Phase 3
130
(Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%)
sybastqbeq(xivmlcoqvd) = pzkfzukjud bnwibcwjov (zjecwovxgg, 0.6)
-
26 Mar 2012
placebo comparator
(Placebo)
sybastqbeq(xivmlcoqvd) = pwnzzuhpms bnwibcwjov (zjecwovxgg, 1.0)
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Approval

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Regulation

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