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Emadine (EMEDASTINE)
Emadine (Emedastine) is a small molecule histamine-1 receptor inhibitor originally developed by Alcon and currently owned by Novartis. It was FDA-approved in 1997 for the treatment of allergic conjunctivitis, itching of the skin, and urticaria. Emadine works by blocking the histamine H1 receptor, which is involved in the allergic response. It is off-patent and has no active generic manufacturers. Key safety considerations include its potential to cause eye irritation and dryness.
At a glance
| Generic name | EMEDASTINE |
|---|---|
| Sponsor | Novartis |
| Drug class | Histamine-1 Receptor Inhibitor |
| Target | Histamine H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1997 |
Approved indications
- Allergic conjunctivitis
- Itching of skin
- Urticaria
Common side effects
Key clinical trials
- Efficacy of Artemisia Pollen Specific Allergen Immunotherapy (PHASE4)
- Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis (PHASE4)
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:
- Emadine CI brief — competitive landscape report
- Emadine updates RSS · CI watch RSS
- Novartis portfolio CI