Friday, July 10, 2026

Drug profile · INN

difluprednate

difluprednate (DIFLUPREDNATE) is a glucocorticoid receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — difluprednate
US status
approved
Class
Route
OPHTHALMIC
Patents
0
Programs
1
Data quality
0.89

Quick answer

difluprednate (DIFLUPREDNATE) is a glucocorticoid receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

Key facts

INN difluprednate
Brand DIFLUPREDNATE
Mechanism Glucocorticoid receptor agonist
Target Glucocorticoid receptor
Route OPHTHALMIC
Formulation EMULSION

Mechanism of action

Glucocorticoid receptor agonist

Primary target: Glucocorticoid receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 4D-150-C004 Phase 3 · 4D Molecular Therapeutics · Macular neovascularization secondary to age-related macular

Related & competitor drugs

  1. beclomethasone dipropionate Glucocorticoid receptor agonist
  2. betamethasone acetate Glucocorticoid receptor agonist
  3. betamethasone dipropionate Glucocorticoid receptor agonist
  4. betamethasone valerate Glucocorticoid receptor agonist
  5. budesonide Alimentary tract and metabolism (A07)
  6. clobetasol propionate Glucocorticoid receptor agonist

Frequently asked questions

What is difluprednate?

difluprednate (DIFLUPREDNATE) is a glucocorticoid receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

What is the brand name for difluprednate?

DIFLUPREDNATE is a marketed brand name for difluprednate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of difluprednate?

difluprednate 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.