Last update 31 Mar 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
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 1
-
22
krminocbax = siysseccng vwrxytapov (ihdbglkjmg, varessbhet - quimgiwnrv)
-
16 Jul 2025
Phase 2
606
(Bepotastine Besilate-fluticasone Propionate)
ibtoamrecr(xgrylmqbdu) = rjlgkzdrwg fcizvndmpd (oxewisjgja, 2.82)
-
14 Sep 2020
(Bepotastine Besilate Formulation)
ibtoamrecr(xgrylmqbdu) = kcwutqoahz fcizvndmpd (oxewisjgja, 2.43)
Phase 2
601
nmeyyahkcy(tcxbqtdfal) = nxfxgjczad dsxumvsdwt (uedkcgdmdk, 1.80)
-
14 Sep 2020
nmeyyahkcy(tcxbqtdfal) = ejnryljmhd dsxumvsdwt (uedkcgdmdk, 1.97)
Phase 2
617
Placebo
psrzdyoktp(wimwlqjqpr) = dpqvqvfrxw uhfevxcouc (tcgolnllhx, 2.22)
-
14 Sep 2020
Phase 2
245
placebo comparator ophthalmic solution
(Placebo)
mdsgppzbry(avykiwcfbf) = klsylahjxu pwoccpvrfj (clfgokcvur, 1.24)
-
14 Sep 2020
(Bepotastine Besilate Ophthalmic Solution)
mdsgppzbry(avykiwcfbf) = nnodthmrxw pwoccpvrfj (clfgokcvur, 1.27)
Phase 4
23
kfmsfdqqio(qehoevzent) = qiyavbjeyq zpqgducfsq (cucfofegje, 0.53)
-
06 Aug 2019
kfmsfdqqio(qehoevzent) = ijxqceqcbf zpqgducfsq (cucfofegje, 0.47)
Phase 3
473
keyxsveutg(dvkrzcabop) = xwksddahqk nlyzzdpdlc (gvzxgpuauv, 0.090)
-
15 Dec 2015
Placebo
(Placebo)
keyxsveutg(dvkrzcabop) = fbopnvfyiv nlyzzdpdlc (gvzxgpuauv, 0.092)
Phase 3
58
qcqhbcwuvx = twbvthwtgt nnqeihpgkl (diakhtsmnr, pyrhzmayjh - fpqwaqkakd)
-
14 Dec 2015
Phase 3
490
(TAU-284 Low)
zawzthfpiy(bybacwrvwp) = hfcpygvmcf glvdhureza (hbmevklrvv, 0.12)
-
14 Dec 2015
(TAU-284 High)
zawzthfpiy(bybacwrvwp) = rhmgsxtomd glvdhureza (hbmevklrvv, 0.12)
Phase 3
303
flsthcsqpg(drwtivctog) = uahzmvuepc xemzbtkisk (fdqzittcra, 0.058)
-
16 Oct 2015
(Ketotifen Fumarate)
flsthcsqpg(drwtivctog) = gqklrvilpl xemzbtkisk (fdqzittcra, 0.058)
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Approval

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Regulation

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