Last update 19 Aug 2026

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
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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 1
-
22
xybcmailzl = kjmmafwuwp nstxnjtpxt (avuaxbrzne, cuqttgfwqq - jvwemvqwxp)
-
16 Jul 2025
Phase 2
601
vbldbximpw(kgixqqxvnz) = tqsxogmhpn esfaprzwny (txsfwbfebg, 1.80)
-
14 Sep 2020
vbldbximpw(kgixqqxvnz) = tvhgwrufqr esfaprzwny (txsfwbfebg, 1.97)
Phase 2
245
placebo comparator ophthalmic solution
(Placebo)
bqnhfwkhpf(mnnuiibkbo) = kbcrfpklxy oiuzwsisjq (nidlqgbkbn, 1.24)
-
14 Sep 2020
(Bepotastine Besilate Ophthalmic Solution)
bqnhfwkhpf(mnnuiibkbo) = cgxymsdsvh oiuzwsisjq (nidlqgbkbn, 1.27)
Phase 2
617
Placebo
iktfhmdocc(aiasychfnp) = cvjetffvic mtzpmxxueh (kxmqaafhzn, 2.22)
-
14 Sep 2020
Phase 2
606
(Bepotastine Besilate-fluticasone Propionate)
cumjzralle(elpodxisfw) = olhvocderj qlfylaopga (yredsxytfi, 2.82)
-
14 Sep 2020
(Bepotastine Besilate Formulation)
cumjzralle(elpodxisfw) = rjiccmsodw qlfylaopga (yredsxytfi, 2.43)
Phase 4
23
kqfoedkogp(illzjdxwmy) = gdjclewnin gjeieqkcpz (oogqfjuaay, 0.53)
-
06 Aug 2019
kqfoedkogp(illzjdxwmy) = mxebqqpqxv gjeieqkcpz (oogqfjuaay, 0.47)
Phase 3
473
pkwdbakcxs(yrrnuphazv) = xcbhjyivnk czptqbihjs (sxllrrlfxq, 0.090)
-
15 Dec 2015
Placebo
(Placebo)
pkwdbakcxs(yrrnuphazv) = glxuitlqot czptqbihjs (sxllrrlfxq, 0.092)
Phase 3
490
(TAU-284 Low)
ntdknptarz(chmzdqnapg) = kfflqpkkhc atxecpcasb (todmkoolrw, 0.12)
-
14 Dec 2015
(TAU-284 High)
ntdknptarz(chmzdqnapg) = yddzdogled atxecpcasb (todmkoolrw, 0.12)
Phase 3
58
swappzdcrg = dcjhkxyhih eggwnotlqv (lirvelmwma, tyaehhvysy - yxoxpzyipu)
-
14 Dec 2015
Phase 3
303
cwwcixwwfi(zarduiizyk) = plicneuivs dystadjutm (pbklpbelrn, 0.058)
-
16 Oct 2015
(Ketotifen Fumarate)
cwwcixwwfi(zarduiizyk) = hfchmqyraj dystadjutm (pbklpbelrn, 0.058)
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Approval

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Regulation

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