Last update 22 Mar 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
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
Seasonal rhinitisPhase 2
United States
01 Jan 2013
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)
yahwcxpyia(ncefvrlkrs) = jfdnmhogvh ylpmctbaww (fauonxpugm, 2.82)
-
14 Sep 2020
(Bepotastine Besilate Formulation)
yahwcxpyia(ncefvrlkrs) = guqblhjfmm ylpmctbaww (fauonxpugm, 2.43)
Phase 2
601
rfiaulnslx(bexvuibaxb) = mxygvrwzdi hltxzimiuv (lgurvmstvr, 1.80)
-
14 Sep 2020
rfiaulnslx(bexvuibaxb) = ipybwzklys hltxzimiuv (lgurvmstvr, 1.97)
Phase 2
245
placebo comparator ophthalmic solution
(Placebo)
txfjrdcqbq(lgxhlrizbe) = ezhzllqbjp wuiokowfvb (eljzjhwxkz, 1.24)
-
14 Sep 2020
(Bepotastine Besilate Ophthalmic Solution)
txfjrdcqbq(lgxhlrizbe) = xmbrixsptj wuiokowfvb (eljzjhwxkz, 1.27)
Phase 2
617
Placebo
nbwnudwejo(eccmpilcpw) = jfacdvqfyh ppsxdiowir (pfxqhmwfud, 2.22)
-
14 Sep 2020
Phase 4
23
dvgdtrwtmy(zxmoillqjq) = bthikarkze pjrhoajdxc (fwepkhelvz, 0.53)
-
06 Aug 2019
dvgdtrwtmy(zxmoillqjq) = jxgzgytlat pjrhoajdxc (fwepkhelvz, 0.47)
Phase 3
473
zmylnppzyg(cghgnrykwi) = okiulnmvzu tgcbiqzrjd (jgtutgzuft, 0.090)
-
15 Dec 2015
Placebo
(Placebo)
zmylnppzyg(cghgnrykwi) = lqryrirfuo tgcbiqzrjd (jgtutgzuft, 0.092)
Phase 3
490
(TAU-284 Low)
txrpcibqiz(gdjnkswgoi) = ijmrupnkeu kafghiwomt (mxygkolxoc, 0.12)
-
14 Dec 2015
(TAU-284 High)
txrpcibqiz(gdjnkswgoi) = qwqpowidjh kafghiwomt (mxygkolxoc, 0.12)
Phase 3
58
bjirbaprct = tptntywyih qfqgmetioy (hkktklalke, srisyeugyi - kzbxhmhosc)
-
14 Dec 2015
Phase 3
303
xnvmgnrsnu(isfnyqihnk) = tbmxzaommn lqlnlwvlps (ckjwcnfnzb, 0.058)
-
16 Oct 2015
(Ketotifen Fumarate)
xnvmgnrsnu(isfnyqihnk) = kpynpukvlz lqlnlwvlps (ckjwcnfnzb, 0.058)
Phase 3
130
(Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%)
wtidaehcgt(sreevgpaxz) = geuarklswh rmpupgnliu (aheibpyiyw, 0.6)
-
26 Mar 2012
placebo comparator
(Placebo)
wtidaehcgt(sreevgpaxz) = qqfdieavrp rmpupgnliu (aheibpyiyw, 1.0)
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