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Bepreve (BEPOTASTINE)
Bepotastine blocks H1 receptors and inhibits histamine release from mast cells.
Bepotastine (Bepreve) is a small molecule histamine-1 receptor antagonist developed by Bausch and Lomb Inc. It targets the histamine H1 receptor to treat allergic conjunctivitis. Bepreve is a generic medication, off-patent since there are no active Orange Book patents. It was FDA approved in 2009 for its approved indications. As a generic medication, it is available from multiple manufacturers.
At a glance
| Generic name | BEPOTASTINE |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Histamine-1 Receptor Antagonist |
| Target | H1-receptor, mast cells |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2009 |
Mechanism of action
Bepotastine works by directly blocking H1 receptors, which prevents the effects of histamine. Additionally, it stops mast cells from releasing histamine, reducing allergic symptoms.
Approved indications
- Allergic conjunctivitis
Common side effects
- mild taste following instillation
Key clinical trials
- A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (PHASE3)
- The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (PHASE3)
- A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (PHASE3)
- A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (PHASE3)
- Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+ (PHASE1)
- Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis (PHASE4)
- Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment (PHASE4)
- Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial 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:
- Bepreve CI brief — competitive landscape report
- Bepreve updates RSS · CI watch RSS
- Bausch Health portfolio CI