Wednesday, July 8, 2026

Drug profile · INN

epinastine hydrochloride

epinastine hydrochloride (EPINASTINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Route of administration: ophthalmic. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 5
Pipeline programs 4
News articles 0
Drug details — epinastine hydrochloride
US status
approved
Class
Route
OPHTHALMIC
Patents
5
Programs
4
Data quality
0.84

Quick answer

epinastine hydrochloride (EPINASTINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Route of administration: ophthalmic. Current US regulatory status: approved.

Key facts

INN epinastine hydrochloride
Brand EPINASTINE HYDROCHLORIDE
Mechanism Histamine H1 receptor antagonist
Target Histamine H1 receptor
Route OPHTHALMIC
Formulation SOLUTION

Mechanism of action

Histamine H1 receptor antagonist

Primary target: Histamine H1 receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Alvelestat Phase 2 · MEREO BIOPHARMA GROUP · Covid19
  2. Alvelestat (MPH966) Phase 2 · MEREO BIOPHARMA GROUP · Alpha-1 Antitrypsin Deficiency (AATD)
  3. Sivelestat Unknown · First People's Hospital · Aortic Dissection
  4. Sivelestat sodium Unknown · First People's Hospital · Aortic Dissection

Related & competitor drugs

  1. azelastine hydrochloride Histamine H1 receptor antagonist
  2. brompheniramine maleate Histamine H1 receptor antagonist
  3. carbinoxamine maleate Histamine H1 receptor antagonist
  4. cetirizine hydrochloride Histamine H1 receptor antagonist
  5. chlorpheniramine maleate Histamine H1 receptor antagonist
  6. clemastine fumarate Histamine H1 receptor antagonist

Related patents

  1. US 11512128

    VEGF/DLL4 binding agents and uses thereof

    Expires Mon Nov 24 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11434204

    Method for producing a polymorphic form of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide

    Expires Mon Sep 01 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11234967

    Use of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-n-cyclopropyl-4-methylbenzamide in the prevention or reduction of acute exacerbations of chronic obstructive pulmonary disease

    Expires Mon Jan 27 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 10995071

    Method for producing a polymorphic form of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide

    Expires Mon Apr 29 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 10934260

    Method for producing a polymorphic form of 3-[5-amino-4-(3- cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide

    Expires Mon Feb 25 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is epinastine hydrochloride?

epinastine hydrochloride (EPINASTINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Route of administration: ophthalmic. Current US regulatory status: approved.

What is the brand name for epinastine hydrochloride?

EPINASTINE HYDROCHLORIDE is a marketed brand name for epinastine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of epinastine hydrochloride?

epinastine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.