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Betahistine Extended Release formulation
Betahistine Extended Release formulation is a Histamine H1 receptor agonist / H3 receptor antagonist Small molecule drug developed by OBEcure Ltd.. It is currently FDA-approved for Menière's disease (vertigo, tinnitus, hearing loss), Vestibular vertigo. Also known as: Vasomotal, Agiserc®, SERC, Betahistine.
Betahistine is a histamine H1 receptor agonist and H3 receptor antagonist that increases blood flow to the inner ear and reduces endolymphatic pressure.
Betahistine is a histamine H1 receptor agonist and H3 receptor antagonist that increases blood flow to the inner ear and reduces endolymphatic pressure. Used for Menière's disease (vertigo, tinnitus, hearing loss), Vestibular vertigo.
At a glance
| Generic name | Betahistine Extended Release formulation |
|---|---|
| Also known as | Vasomotal, Agiserc®, SERC, Betahistine |
| Sponsor | OBEcure Ltd. |
| Drug class | Histamine H1 receptor agonist / H3 receptor antagonist |
| Target | Histamine H1 receptor, Histamine H3 receptor |
| Modality | Small molecule |
| Therapeutic area | Otolaryngology / Neurology |
| Phase | FDA-approved |
Mechanism of action
Betahistine works primarily by antagonizing H3 receptors on histaminergic neurons, which increases histamine release and subsequent H1 receptor activation in the inner ear vasculature. This leads to improved microcirculation in the cochlea and vestibular system, reducing endolymphatic hydrops and alleviating symptoms of vertigo and inner ear dysfunction. The extended-release formulation provides sustained drug levels to maintain therapeutic benefit over a longer dosing interval.
Approved indications
- Menière's disease (vertigo, tinnitus, hearing loss)
- Vestibular vertigo
Common side effects
- Headache
- Nausea
- Dyspepsia
- Pruritus
Key clinical trials
- Evaluation of Co-Administration of Betahistine as Adjunctive to Olanzapine in Healthy Subjects (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Betahistine Extended Release formulation CI brief — competitive landscape report
- Betahistine Extended Release formulation updates RSS · CI watch RSS
- OBEcure Ltd. portfolio CI
Frequently asked questions about Betahistine Extended Release formulation
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Related
- Drug class: All Histamine H1 receptor agonist / H3 receptor antagonist drugs
- Target: All drugs targeting Histamine H1 receptor, Histamine H3 receptor
- Manufacturer: OBEcure Ltd. — full pipeline
- Therapeutic area: All drugs in Otolaryngology / Neurology
- Indication: Drugs for Menière's disease (vertigo, tinnitus, hearing loss)
- Indication: Drugs for Vestibular vertigo
- Also known as: Vasomotal, Agiserc®, SERC, Betahistine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing