Epinastine

Overview

Epinastine is used for the prevention of itching associated with allergic conjunctivitis. It has a multi-action effect that inhibits the allergic response in 3 ways: 1. stabilizes mast cells by preventing mast cell degranulation to control the allergic response, 2. prevents histamine binding to both the H1- and H2-receptors to stop itching and provide lasting protection, and 3. prevents the release of proinflammatory chemical mediators from the blood vessel to halt progression of the allergic response.

Indication

For the prevention of itching associated with allergic conjunctivitis.

Associated Conditions

Allergic Conjunctivitis (AC)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients	2024/01/19	NCT06212973	Phase 3	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Dose Tolerance Study in Healthy Male Volunteers After Intranasal Application of Epinastine Nasal	2014/10/09	NCT02260037	Phase 1	Completed	Boehringer Ingelheim
Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers	2014/10/09	NCT02260063	Phase 1	Completed	Boehringer Ingelheim
Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan	2014/09/29	NCT02251613	Phase 4	Completed	Alcon Research
Epinastine + Pseudoephedrine SR (Slow Release) Versus Epinastine Alone in Patients With Perennial Allergic Rhinitis	2014/07/08	NCT02182518	Phase 3	Completed	Boehringer Ingelheim
Epinastine and Pseudoephedrine Fixed Combination Compared to Separate Administration in Healthy Volunteers	2014/07/08	NCT02182531	Phase 1	Completed	Boehringer Ingelheim
Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis	2011/06/27	NCT01382654	Phase 2	Completed	Merck Sharp & Dohme LLC
Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)	2007/11/28	NCT00564421	Phase 3	Completed	Merck Sharp & Dohme LLC
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis	2007/09/26	NCT00534794	Phase 4	Completed	Merck Sharp & Dohme LLC
Comparison of CL Wear Between Two Allergy Drops	2007/06/21	NCT00489398	Phase 4	Withdrawn	Hom, Milton M., OD, FAAO

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
EPINASTINE HYDROCHLORIDE	Somerset Therapeutics, LLC	70069-008	OPHTHALMIC	0.5 mg in 1 mL	11/9/2023
Epinastine Hydrochloride	Breckenridge Pharmaceutical, Inc.	51991-836	OPHTHALMIC	0.5 mg in 1 mL	11/1/2021
EPINASTINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	62756-329	OPHTHALMIC	0.5 mg in 1 mL	10/24/2018

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Epinastine Hydrochloride Tablets	广州市联瑞制药有限公司	国药准字H20223745	化学药品	片剂	10/11/2022
Epinastine Hydrochloride Tablets	NIHON PHARMACEUTICAL INDUSTRY CO., LTD.	国药准字HJ20230053	化学药品	片剂	5/19/2023
Epinastine Hydrochloride Tablets	森飞医药科技（重庆）有限公司	国药准字H20244770	化学药品	片剂	8/27/2024
Epinastine Hydrochloride Tablets	森飞医药科技（重庆）有限公司	国药准字H20244773	化学药品	片剂	8/27/2024
Epinastine Hydrochloride Tablets	兆科药业（广州）有限公司	国药准字H20243678	化学药品	片剂	5/15/2024
Epinastine Hydrochloride Tablets	广州市联瑞制药有限公司	国药准字H20223744	化学药品	片剂	10/11/2022
Epinastine Hydrochloride Tablets	北京金城泰尔制药有限公司	国药准字H20055057	化学药品	片剂	5/15/2020
Epinastine Hydrochloride Granules	广州一品红制药有限公司	国药准字H20223748	化学药品	颗粒剂	10/11/2022
Epinastine Hydrochloride Granules	广州一品红制药有限公司	国药准字H20223747	化学药品	颗粒剂	10/11/2022
Epinastine Hydrochloride Granules	广州市联瑞制药有限公司	国药准字H20213886	化学药品	颗粒剂	11/24/2021

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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