betahistine mesilate

Small moleculeexperimental

Betahistine is an orally administered, centrally acting histamine H1 receptor agonist with partial H3 antagonistic activity. It is proposed that betahistine may reduce peripherally the asymmetric functioning of the sensory vestibular organs in addition to increasing vestibulocochlear blood flow by antagonising local H3 heteroreceptors. Betahistine acts centrally by enhancing histamine synthesis within tuberomammillary nuclei of the posterior hypothalamus and histamine release within vestibular nuclei through antagonism of H3 autoreceptors. This mechanism, together with less specific effects of betahistine on alertness regulation through cerebral H1 receptors, should promote and facilitate central vestibular compensation. Betahistine is used to treat the symptoms associated with Ménière's disease, a condition of the inner ear which causes, vertigo (dizziness), tinnitus (ringing in the ears), hearing loss. — NCATS

Clinical trial activity

37 trials · 54 clinical orgs · 0 marketing orgs

Phase 1
6
Phase 2
9
Phase 3
1
Phase 4
6

Earliest trial started Jan 1, 2003 (NCT00160238)

Timeline

2000s

  1. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

  • HRH1 agonist

    Betahistine has a very strong affinity as an antagonist for histamine H3 receptors and a weak affinity as an agonist for histamine H1 receptors. Its efficacy can be explained by mechanisms targeting these histamine receptors (HRs) at three different levels: the vascular tree, with an increase of cochlear and vestibular blood flow involving the H1R; the central nervous system, with an increase of histamine turnover implicating the H3R, and the peripheral labyrinth, with a decrease of vestibular input implying the H3R/H4R.

    Betahistine is a strong Histamine H3 receptor antagonist and a weak Histamine H1 agonist.

  • HRH3 antagonist

  • HRH3 antagonist

    Betahistine has a very strong affinity as an antagonist for histamine H3 receptors and a weak affinity as an agonist for histamine H1 receptors. Its efficacy can be explained by mechanisms targeting these histamine receptors (HRs) at three different levels: the vascular tree, with an increase of cochlear and vestibular blood flow involving the H1R; the central nervous system, with an increase of histamine turnover implicating the H3R, and the peripheral labyrinth, with a decrease of vestibular input implying the H3R/H4R.

    Betahistine is a strong Histamine H3 receptor antagonist and a weak Histamine H1 agonist.

Chemistry & pharmacology

Loading structure…

SMILES

CNCCc1ccccn1
Mol. weight
136.2 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 2-[2-(methylamino)ethyl]pyridine
  • 2-[2-(methylamino)ethyl]pyridine
  • [2-(2-pyridyl)ethyl]methylamine
  • [2-(2-pyridyl)ethyl]methylamine
  • 2-(beta-methylaminoethyl)pyridine
  • 2-(beta-methylaminoethyl)pyridine
  • betahistina
  • betahistina
  • betahistine
  • betahistine
  • betahistine
  • betahistine
  • betahistine
  • betahistine
  • betahistine
  • beta-histine
  • betahistine dihydrobromide
  • betahistine dihydrochloride
  • betahistine dihydrochloride
  • betahistine dihydrochloride
  • betahistine dihydrochloride
  • betahistine dihydrochloride
  • betahistine dihydrochloride
  • betahistine dihydrochloride
  • betahistine hcl
  • betahistine hcl
  • betahistine hydrochloride
  • betahistine hydrochloride
  • betahistine hydrochloride
  • betahistine hydrochloride
  • betahistine mesilate
  • betahistine mesilate
  • betahistine mesilate
  • betahistine mesilate
  • betahistine mesylate
  • betahistine methanesulfonate
  • betahistinum
  • betahistinum
  • merislon
  • n-methyl-2-(2-pyridinyl)ethanamine
  • n-methyl-2-(2-pyridinyl)ethanamine
  • n-methyl-2-pyridineethanamine
  • n-methyl-2-pyridineethanamine
  • pt-9
  • pt-9
  • serc
  • serc
  • serc-16
  • serc-8
  • verum
  • verum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07017244N/AJun 15, 2025Azienda Ospedaliera Universitaria Policlinico G. Martino
NCT07075289Phase 4Apr 1, 2024Dexa Medica Group, Universitas Sebelas Maret
NCT06001593Phase 1/Phase 2 (Phase 2)Sep 7, 2023Seoul National University
NCT06123234N/AApr 1, 2023Azienda Ospedaliera Universitaria Policlinico G. Martino
NCT05757050N/AMar 13, 2023A. Vogel AG, Newcastle University
NCT05604937N/ADec 31, 2022Shanghai University of Traditional Chinese Medicine
NCT05598749N/AOct 31, 2022Fytexia, Universidad Católica San Antonio de Murcia
NCT06218225N/AOct 15, 2022Azienda Ospedaliera Universitaria Policlinico G. Martino
NCT05472285N/AMay 23, 2022Biofortis, Bionov
NCT05098249Phase 4Nov 11, 2021University of Zurich
NCT05938517Phase 1Jun 2, 2021Ludwig Maximilians University
NCT06544434Phase 2May 1, 2021Capital Medical University
NCT05328895N/AOct 1, 2020Capital Medical University
NCT03823196N/AMar 8, 2019Fytexia, Universidad Católica San Antonio de Murcia
NCT03624283N/ASep 1, 2018Fudan University
NCT03627117N/AAug 13, 2018University of Basel
NCT07059533N/AMar 31, 2017Ecole Polytechnique Fédérale de Lausanne
NCT04283266N/AJun 12, 2016Vesale Pharma
NCT02392767N/AOct 1, 2014BioTeSys GmbH, Dr. Loges & Co. GmbH
NCT02026778N/ADec 1, 2013Yonsei University
Showing 20 of 37 trials
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Organizations

Research & Development (54)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
OBEcure Ltd.For profit6622007
Azienda Ospedaliera Universitaria Policlinico G. MartinoAcademic/Hospital3312022
Capital Medical UniversityAcademic/Hospital3232007
FytexiaAcademic/Hospital2212019
Universidad Católica San Antonio de MurciaAcademic/Hospital2012019
University of CincinnatiAcademic/Hospital2112006
AbbottFor profit1112012
AlvogenFor profit1112013
A. Vogel AGFor profit1112023
BiofortisFor profit1012022
BionovFor profit1112022
BioTeSys GmbHFor profit1012014
Bonn Education Association for Dietetics r.A., Cologne, GermanyAcademic/Hospital1112004
Cahaba Research, IncFor profit1012007
CovanceFor profit1012007
Dexa Medica GroupFor profit1012024
Diablo Clinical ResearchFor profit1012007
Dr. Loges & Co. GmbHFor profit1112014
Ecole Polytechnique Fédérale de LausanneAcademic/Hospital1112017
EisaiFor profit1112007
54 organizations
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