BEPOTASTINE BESILATE
Bepotastine besilate is an eye drop used to manage the itching that comes with allergic conjunctivitis. It helps patients who experience the various signs and symptoms of ocular allergies. This medication is typically prescribed to provide relief from the persistent itchiness associated with this condition.
How BEPOTASTINE BESILATE Works
This medication works by directly blocking H1-receptors to stop the effects of histamine in the eye. It also prevents mast cells from releasing more histamine into the surrounding tissue. By targeting these pathways, the drug effectively reduces the allergic response and the resulting itch.
Details
- Status
- Prescription
- First Approved
- 2019-03-05
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS, SOLUTION
BEPOTASTINE BESILATE Approval History
What BEPOTASTINE BESILATE Treats
1 indicationsBEPOTASTINE BESILATE is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Allergic Conjunctivitis
BEPOTASTINE BESILATE Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BEPOTASTINE BESILATE
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01861522 results posted | TAU-284-20 | Ph 3 | completed | The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis |
| NCT01840605 results posted | TAU-284-19 | Ph 3 | completed | A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis |
| NCT01900054 results posted | TAU-284-18 | Ph 3 | completed | A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis |
| NCT04693429 PRO-172 results posted | SOPH172-0919/I | Ph 1 | completed | Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+ |
| NCT01753739 results posted | 823 | Ph 2 | completed | Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BEPOTASTINE BESILATE FDA Label Details
Indications & Usage
BEPOTASTINE BESILATE is indicated for the treatment of Allergic Conjunctivitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.