Friday, July 10, 2026

Drug profile · INN

fluocinolone acetonide

fluocinolone acetonide (RETISERT) is a glucocorticoid receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: topical. Current US regulatory status: approved.

FDA: approved EMA: application withdrawn
US status approved
Patents linked 15
Pipeline programs 14
News articles 0
Drug details — fluocinolone acetonide
US status
approved
Class
Route
TOPICAL
Patents
15
Programs
14
Data quality
0.89

Quick answer

fluocinolone acetonide (RETISERT) is a glucocorticoid receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN fluocinolone acetonide
Brand RETISERT
Mechanism Glucocorticoid receptor agonist
Target Glucocorticoid receptor
Route TOPICAL
Formulation IMPLANT

Mechanism of action

Glucocorticoid receptor agonist

Primary target: Glucocorticoid receptor

Approval history

Authority Status Date
FDA approved
EMA application withdrawn

Pipeline programs

  1. ARG-01-2024 Phase 3 · HRA Pharma · rhinosinusitis not requiring antibiotic therapy, rhinopharyn
  2. COMB157G2399 Phase 3 · Novartis India · Relapsing multiple sclerosis (RMS)
  3. Yutiq 0.18 MG Drug Implant Phase 3 · ANI PHARMACEUTICALS · Uveitis
  4. fluocinolone acetonide Phase 3 · ANI PHARMACEUTICALS · Diabetic Macular Edema
  5. 0.59 mg fluocinolone acetonide intravitreal implant Phase 2 · Bausch + Lomb · Diabetic Macular Edema
  6. Fluocinolone Acetonide Phase 2 · ANI PHARMACEUTICALS · Macular Edema
  7. Fluocinolone Acetonide Phase 2 · ANI PHARMACEUTICALS · Age-Related Macular Degeneration
  8. DOTAREM for Breast Cancer Approved · Disc Medicine · Breast Cancer

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
  1. US 2020339710

    GLYCOPHOSPHOLIPID POLYMERIC NETWORK AND USE THEREOF

    Expires Wed Oct 24 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 2020239601

    CROSSLINKED POLYMERIC NETWORK AND USE THEREOF

    Expires Wed Jul 25 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. CA 2883399

    REDUCTION AU MINIMUM DE DEPOTS LIPIDIQUES BIOLOGIQUES SUR DES LENTILLES DE CONTACT

    Expires Wed Apr 12 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. CA 2881745

    COMPOSITIONS OPHTALMIQUES CONTENANT DES ACIDES GRAS OMEGA -3

    Expires Wed Mar 01 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. WO 2013169458

    COMPOSITIONS PHARMACEUTIQUES ET MÉTHODES DE TRAITEMENT, DE CONTRÔLE, D'AMÉLIORATION, OU D'INVERSION DES TROUBLES DE LA KÉRATOCONJONCTIVITE SÈCHE

    Expires Wed Nov 09 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 2013289070

    Use of Levocabastine for Modulating Generation of Pro-Inflammatory Cytokines

    Expires Wed Oct 26 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. WO 2013133980

    DÉRIVÉS NITROXY DE STÉROÏDES DOUX

    Expires Wed Sep 07 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. WO 2013126156

    COMPOSÉS AGONISTES DE RÉCEPTEURS DE GLUCOCORTICOÏDES SÉLECTIFS DONNEURS D'OXYDE NITRIQUE ET COMPOSITIONS OPHTALMIQUES

    Expires Wed Aug 24 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. CA 2864833

    COMPOSITIONS OPHTALMIQUES COMPRENANT DES CIRES NATURELLES ALCOXYLEES

    Expires Wed Aug 24 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. EP 2624836

    BEPOTASTIN-ZUSAMMENSETZUNG

    Expires Tue Aug 09 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. CA 2851492

    COMPOSITIONS OPHTALMIQUES EN GEL

    Expires Wed Mar 23 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. CA 2838876

    COMPOSITIONS ET PROCEDES DE TRAITEMENT, DE SUPPRESSION, DE REDUCTION OU D'AMELIORATION D'UNE DOULEUR INFLAMMATOIRE

    Expires Wed Dec 08 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 2012255544

    BEPOTASTINE COMPOSITIONS

    Expires Wed Oct 06 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. WO 2012039887

    COMPOSITION ET MÉTHODE ACCÉLÉRANT LA CICATRISATION DES PLAIES

    Expires Wed Mar 24 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. WO 2011162951

    COMPOSITIONS ET PROCÉDÉS D'AMÉLIORATION DE LA RÉDUCTION D'UN MICRO-ORGANISME SPOROGÈNE

    Expires Wed Dec 24 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is fluocinolone acetonide?

fluocinolone acetonide (RETISERT) is a glucocorticoid receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for fluocinolone acetonide?

RETISERT is a marketed brand name for fluocinolone acetonide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of fluocinolone acetonide?

fluocinolone acetonide 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.