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Ketotifen Fumarate 0.035%
Ketotifen is a selective H1-receptor antagonist and mast cell stabilizer that prevents allergic reactions by blocking histamine release and reducing mast cell degranulation.
Ketotifen is a selective H1-receptor antagonist and mast cell stabilizer that prevents allergic reactions by blocking histamine release and reducing mast cell degranulation. Used for Allergic conjunctivitis, Itching associated with allergic conditions of the eye.
At a glance
| Generic name | Ketotifen Fumarate 0.035% |
|---|---|
| Sponsor | Bausch & Lomb Incorporated |
| Drug class | H1-receptor antagonist and mast cell stabilizer |
| Target | H1 histamine receptor |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology / Allergy |
| Phase | Phase 3 |
Mechanism of action
Ketotifen works through dual action: it competitively blocks H1 histamine receptors to prevent histamine-mediated allergic symptoms, and it stabilizes mast cells to reduce the release of inflammatory mediators including histamine, tryptase, and leukotrienes. This combination makes it particularly effective for allergic conditions affecting the eye.
Approved indications
- Allergic conjunctivitis
- Itching associated with allergic conditions of the eye
Common side effects
- Headache
- Conjunctival injection
- Eye irritation
- Dry eye
Key clinical trials
- Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution (PHASE3)
- Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis (PHASE3)
- Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis (PHASE3)
- A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle (PHASE3)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
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- Ketotifen Fumarate 0.035% CI brief — competitive landscape report
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