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Merislon (BETAHISTINE)

Phase 2 active Small molecule Under review

Merislon (generic name: BETAHISTINE) is a betahistine drug. It is currently in Phase 2 development for Ménière's disease.

Merislon works by binding to the histamine H3 receptor, which helps to regulate the balance of fluids in the inner ear.

Merislon is a small molecule with the synonyms BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE HCL, BETAHISTINE HYDROCHLORIDE, and it has been studied in clinical trials for Meniere Disease, Vertigo, and Cervicogenic Dizziness. In one clinical trial, Merislon was compared to taVNS and MLS laser therapy in the treatment of Meniere Disease.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034 —
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameBETAHISTINE
Drug classbetahistine
TargetHistamine H3 receptor
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Think of the histamine system like a thermostat in your body. When histamine levels get too high, it can cause problems like Ménière's disease. Merislon helps to calm down the thermostat by blocking the histamine H3 receptor, which helps to restore balance to the inner ear.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Merislon

What is Merislon?

Merislon (BETAHISTINE) is a betahistine drug, indicated for Ménière's disease.

How does Merislon work?

Merislon works by binding to the histamine H3 receptor, which helps to regulate the balance of fluids in the inner ear.

What is Merislon used for?

Merislon is indicated for Ménière's disease.

What is the generic name of Merislon?

BETAHISTINE is the generic (nonproprietary) name of Merislon.

What drug class is Merislon in?

Merislon belongs to the betahistine class. See all betahistine drugs at /class/betahistine.

What development phase is Merislon in?

Merislon is in Phase 2.

What are the side effects of Merislon?

Common side effects of Merislon include Soft tissue mass, Oesophageal perforation, Hyponatraemia, Multimorbidity, Dizziness, Hypoglycaemia.

What does Merislon target?

Merislon targets Histamine H3 receptor and is a betahistine.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing