Overview
Bepotastine is a non-sedating, selective antagonist of the histamine 1 (H1) receptor. Bepotastine was approved in Japan for use in the treatment of allergic rhinitis and uriticaria/puritus in July 2000 and January 2002, respectively, and is marketed by Tanabe Seiyaku Co., Ltd. under the brand name Talion. It is available in oral and opthalmic dosage forms in Japan. The opthalmic solution is FDA approved since Sept 8, 2009 and is under the brand name Bepreve.
Background
Bepotastine is a non-sedating, selective antagonist of the histamine 1 (H1) receptor. Bepotastine was approved in Japan for use in the treatment of allergic rhinitis and uriticaria/puritus in July 2000 and January 2002, respectively, and is marketed by Tanabe Seiyaku Co., Ltd. under the brand name Talion. It is available in oral and opthalmic dosage forms in Japan. The opthalmic solution is FDA approved since Sept 8, 2009 and is under the brand name Bepreve.
Indication
用于治疗过敏性鼻炎；荨麻疹；皮肤疾病引起的瘙痒（湿疹•皮炎、痒疹、皮肤瘙痒症）。
Associated Conditions
- Pruritus
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/04/26 | Phase 3 | Completed | |||
2012/12/20 | Phase 2 | Completed | |||
2012/04/16 | Phase 2 | Completed | |||
2011/10/12 | Not Applicable | Completed | McCabe Vision Center | ||
2011/09/29 | Phase 4 | Completed | Southern California College of Optometry at Marshall B. Ketchum University | ||
2011/08/30 | Phase 3 | Completed | |||
2011/05/03 | Phase 4 | Completed | |||
2011/04/19 | Phase 4 | UNKNOWN | Hom, Milton M., OD, FAAO | ||
2011/01/14 | Phase 2 | Completed | |||
2010/10/18 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||