Overview
Ménière's disease is a progressive disease of the inner ear characterized by vertigo, tinnitus, and hearing loss. It has a significant impact on both the physical and social functioning of affected individuals. Betahistine is a histamine-like antivertigo drug used for treating symptoms associated with Ménière's disease. It is thought to reduce symptoms through its actions on histamine receptors. Betahistine was first approved by the FDA in the 1970s but withdrawn within approximately 5 years due to a lack of evidence supporting its efficacy. It is currently marketed in Canada by various companies, including Teva Pharmaceuticals.
Indication
Betahistine is indicated for the reduction of recurrent vertigo episodes associated with Ménière's disease in patients 18 years old and above.
Associated Conditions
- Menière's Disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/09 | Phase 2 | Recruiting | Beijing Tongren Hospital | ||
2024/08/09 | N/A | Completed | Beijing Tongren Hospital | ||
2023/08/21 | Phase 1 | Recruiting | |||
2023/07/10 | Phase 1 | Completed | |||
2022/11/03 | Not Applicable | Completed | Zhan Yunfan | ||
2018/08/10 | Not Applicable | UNKNOWN | |||
2011/11/09 | Phase 4 | Completed | Abbott Products | ||
2010/07/23 | Phase 1 | Completed | |||
2009/02/27 | Phase 1 | Completed | |||
2009/01/27 | Phase 1 | Completed | P2D, Inc. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BETASERC 24 TABLET 24 mg | SIN12235P | TABLET | 24 mg | 3/24/2003 | |
| MERISLON TABLET 6 mg | SIN03047P | TABLET | 6 mg | 6/7/1989 | |
| GP-BETAHISTINE TABLETS 24MG | SIN16812P | TABLET | 24mg | 6/21/2023 | |
| BETASERC TABLETS 16 mg | SIN11365P | TABLET | 16 mg | 8/2/2000 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Betahistine Mesilate Tablets | 国药准字H20253804 | 化学药品 | 片剂 | 4/1/2025 | |
| Betahistine Mesilate Tablets | 国药准字H20244384 | 化学药品 | 片剂 | 7/9/2024 | |
| Betahistine Mesilate Tablets | 国药准字H20100025 | 化学药品 | 片剂 | 1/6/2020 | |
| Betahistine Mesilate Tablets | 国药准字H20040130 | 化学药品 | 片剂 | 7/9/2020 | |
| Betahistine Hydrochloride for Injection | 国药准字H20030473 | 化学药品 | 注射剂 | 10/10/2020 | |
| Betahistine Hydrochloride Oral Solution | 国药准字H20133114 | 化学药品 | 口服溶液剂 | 9/20/2022 | |
| Betahistine Hydrochloride Oral Solution | 国药准字H20184108 | 化学药品 | 口服溶液剂 | 7/8/2023 | |
| Betahistine Hydrochloride Oral Solution | 国药准字H20013069 | 化学药品 | 口服溶液剂 | 4/26/2020 | |
| Betahistine Hydrochloride Oral Solution | 国药准字H23020091 | 化学药品 | 口服溶液剂 | 7/5/2020 | |
| Betahistine Hydrochloride Oral Solution | 国药准字H20058268 | 化学药品 | 口服溶液剂 | 12/10/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| MERISLON TAB 6MG | N/A | N/A | N/A | 10/23/2001 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BETAHISTINE LUPIN betahistine dihydrochloride 16mg tablet blister pack | 388870 | Medicine | A | 10/13/2022 | |
| APO-BETAHISTINE betahistine dihydrochloride 16 mg uncoated tablet blister pack | 217105 | Medicine | A | 10/20/2014 | |
| BETAHISTINE GH betahistine dihydrochloride 16 mg tablets blister packs | 212076 | Medicine | A | 8/14/2014 | |
| BETAHISTINE-WGR betahistine dihydrochloride 16 mg tablets blister packs | 212078 | Medicine | A | 8/14/2014 | |
| SETEAR betahistine dihydrochloride 24 mg tablet blister pack | 261439 | Medicine | A | 3/2/2017 | |
| BETISTAVERT betahistine dihydrochloride 16 mg tablets blister packs | 212087 | Medicine | A | 8/14/2014 | |
| BEHISTATINE betahistine dihydrochloride 16 mg tablets blister packs | 212084 | Medicine | A | 8/14/2014 | |
| BETAHISTINE GPPL betahistine dihydrochloride 16 mg tablets blister packs | 212085 | Medicine | A | 8/14/2014 | |
| BETASERT betahistine dihydrochloride 16 mg tablets blister packs | 212080 | Medicine | A | 8/14/2014 | |
| SERBEHIST betahistine dihydrochloride 16 mg tablets blister packs | 212086 | Medicine | A | 8/14/2014 |
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