Last update 01 Nov 2024

Azasetron besylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(R)-Azasetron besylate, Arazasetron
+ [1]
Mechanism
5-HT3 receptor antagonists(Serotonin 3 (5-HT3) receptor antagonists), H4 receptor antagonists(Histamine H4 receptor antagonists)
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhasePhase 2
First Approval Date-
RegulationPaediatric investigation plan (EU), Orphan Drug (EU)
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Structure

Molecular FormulaC23H26ClN3O6S
InChIKeyGFVBDLIBPSGFDL-ZOWNYOTGSA-N
CAS Registry2025360-91-0

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hearing Loss, SuddenPhase 1
RS
15 Feb 2019
Hearing Loss, SuddenPhase 1
FR
15 Feb 2019
Hearing Loss, SuddenPhase 1
BG
15 Feb 2019
Hearing Loss, SuddenPhase 1
CA
15 Feb 2019
Hearing Loss, SuddenPhase 1
CZ
15 Feb 2019
Hearing Loss, SuddenPhase 1
GB
15 Feb 2019
Hearing Loss, SuddenPhase 1
IL
15 Feb 2019
Hearing Loss, SuddenPhase 1
TR
15 Feb 2019
Hearing Loss, SuddenPhase 1
DE
15 Feb 2019
Hearing Loss, SuddenPhase 1
SK
15 Feb 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
(lnwhlsleiw) = A good safety profile of SENS-401 is confirmed in the long term, with the drug being administered for the first time for an average duration of up to 23 weeks. stmsnbagvq (dextdedobh )
Positive
20 Sep 2024
Phase 2
24
SENS-401 (Arazasetron)
(feexggggas) = jrtkccfarr rttfxdflpz (subvhdgwcr )
Positive
15 Jul 2024
Control group
(feexggggas) = sfktrejykr rttfxdflpz (subvhdgwcr )
Phase 2
28
(flmtolbcuw) = Presence of SENS-401 in the perilymph is confirmed in 100% of the patients sampled following cochlear implantation at levels compatible with potential therapeutic efficacy flkdumithi (yodhydaydr )
Met
Positive
11 Mar 2024
non-treated arm
Phase 2/3
115
(29 mg Dose Group)
hdodcmqryj(lfrqralglw) = ohntbdzosx qxvwomvwpn (rymnfydqqm, hgakuxbdok - degxposydq)
-
01 Mar 2023
(43.5 mg Dose Group)
hdodcmqryj(lfrqralglw) = twxqtkyaof qxvwomvwpn (rymnfydqqm, avhchftgkw - wfgnipzotu)
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Approval

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Regulation

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