Product Description
Betahistine is a medicine used to treat the symptoms of Ménière's disease. Symptoms include: dizziness (vertigo) ringing in the ears (tinnitus) loss of hearing. (Sourced from: https://www.nhs.uk/medicines/betahistine/)
Mechanisms of Action: HRH3 Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | Uruguay | Venezuela | Vietnam
Approved Indications: None
Company: Otifex Therapeutics
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Spain
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Hearing Loss|Meniere Disease|Tinnitus
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2024-518347-38-00 |
0796-19 | P3 |
Not yet recruiting |
Hearing Loss|Tinnitus|Meniere Disease |
2026-12-31 |
2025-05-02 |
Treatments |
|
2020-005246-42 |
BERTIGO | P3 |
Active, not recruiting |
Tinnitus|Hearing Loss|Meniere Disease |
2022-10-23 |
2025-07-09 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
07/15/2025 |
News Article |
Altamira Therapeutics Announces Allowance of Japanese Patent Application Covering Intranasal Betahistine |
|
06/17/2025 |
News Article |
Public Advisory - Accel-Ondansetron ODT, Mint-Betahistine and PMS-Pirfenidone tablets recalled due to data integrity concerns |
|
04/30/2025 |
News Article |
Altamira Therapeutics Provides Business Update, Reports Full Year 2024 Financial Results |
|
09/26/2024 |
News Article |
Sunshine Biopharma Launches Two New Generic Prescription Drugs |