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Elestat (EPINASTINE)
Elestat works by binding to the histamine H1 receptor, blocking the action of histamine and reducing allergic symptoms.
Elestat (EPINASTINE) is a small molecule adrenergic receptor agonist that targets the histamine H1 receptor. It was originally developed by Allergan and is currently owned by the same company. FDA approved in 2003, it is used to treat allergic conjunctivitis and ocular itching. Elestat is off-patent, with six generic manufacturers available. Key safety considerations include its 12-hour half-life.
At a glance
| Generic name | EPINASTINE |
|---|---|
| Sponsor | AbbVie |
| Drug class | Adrenergic Receptor Agonist |
| Target | Histamine H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2003 |
Mechanism of action
Epinastine is topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from the mast cell. Epinastine is selective for the histamine H1-receptor and has affinity for the histamine H2-receptor. Epinastine also possesses affinity for the 1, 2-, and 5-HT2-receptors.
Approved indications
- Prevention of itching due to allergic conjunctivitis
Common side effects
- infection
- burning sensation in the eye
- folliculosis
- hyperemia
- pruritus
- headache
- rhinitis
- sinusitis
- increased cough
- pharyngitis
- lacrimation increased
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients (PHASE3)
- Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis (PHASE4)
- Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648) (PHASE3)
- Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis (PHASE2)
- A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (PHASE2)
- Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan (PHASE4)
- Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis (PHASE4)
- Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis (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 |
|---|---|
| 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:
- Elestat CI brief — competitive landscape report
- Elestat updates RSS · CI watch RSS
- AbbVie portfolio CI