Drugs / Difluprednate
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | DUREZOL | — | 2012-06-13 – 2013-03-22 | fda.gov ↗ |
| Approved | US (FDA) | DUREZOL | — | 2008-06-23 | fda.gov ↗ |
Trials 18 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT01276223 | Feb 2011 → Jan 2012 | dry eye syndrome | Alcon Research | Completed | No outcome recorded |
| Phase 2 | NCT00406497 | Apr → Jul 2003 | — | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00405496 | Mar 2000 → Apr 2001 | anterior uveitis | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00407225 | Dec 1999 → Oct 2000 | — | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT04097730 | Sep 2020 → May 2024 | keratitis | Thomas M. Lietman | Completed | No outcome recorded |
| Phase 3 | NCT03693989 | Oct 2018 → Aug 2019 | cataract | Laboratorios Sophia S.A de C.V. | Completed | No outcome recorded |
| Phase 3 | NCT01201798 | Oct 2010 → Aug 2011 | anterior uveitis | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT01124045 | Aug 2010 → Apr 2012 | cataract | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00616993 | Jan → Mar 2008 | — | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00616070 | Dec 2007 → Mar 2008 | — | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00406341 | Apr 2004 → Mar 2005 | — | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00407056 | Aug 2002 → Jun 2003 | panuveitis | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00406887 | Aug 2002 → Nov 2003 | anterior uveitis, panuveitis | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00501579 | — | anterior uveitis | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00429923 | — | — | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00430092 | — | — | Sirion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04631315 | Mar 2019 → May 2020 | cataract | Laboratorios Poen | Completed | No outcome recorded |
| Phase 4 | NCT01939691 | Sep 2018 → Mar 2020 | macular retinal edema, uveitis | University of California, San Francisco | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT06271772 Background | Jul 2024 → Jun 2026 overdue | keratitis | University of California, San Francisco | Active not recruiting | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05649111 Comparator | Nov 2022 → Feb 2023 | anterior uveitis | Kafrelsheikh University | Unknown | No outcome recorded |
| Phase 4 | NCT04687800 Comparator | Dec 2020 → Oct 2022 | cataract | Cathleen McCabe MD | Terminated | No outcome recorded |
| Phase 4 | NCT01244334 Comparator | Mar 2009 → Jun 2010 | cataract, corneal edema, retinal degeneration, transient refractive change | Edward J. Holland | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Difluprednate | “standard therapy controlled topical steroid Durezol (Difluprednate ophthalmic emulsion) 0.05%” NCT04687800 ↗ |
| Known as | DFBA | “0.05% difluprednate ophthalmic emulsion (DFBA)” NCT00406887 ↗ |
| Known as | Difluprednato | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201749 ↗ |
| Known as | Durezol | “Difluprednate ophthalmic emulsion 0.05% (Durezol) 2 or 4 times a day compared with those of a placebo in the treatment of inflammation and pain associated with ocular surgery.” PMID 19101421 ↗ Jan 20092“standard therapy controlled topical steroid Durezol (Difluprednate ophthalmic emulsion) 0.05%” NCT04687800 ↗ “Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1%” PMID 20809807 ↗ Oct 2010 |
| Known as | PRO-145 | “difluprednate 0.05% (PRO-145) versus prednisolone acetate 1% (Prednefrin® SF),” PMID 32606573 ↗ Jun 2020 |
| Known as | W 6309 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201749 ↗ |
| Action | Activate | “Glucocorticoid receptor agonist” CHEMBL1201749 ↗ |
| Modality | Small molecule | — CHEMBL1201749 ↗ |
| Route | Topical | “One day after unilateral ocular surgery, patients who had an anterior chamber cell grade of 2 or higher (>10 cells) were treated with 1 drop of difluprednate 2 times or 4 times...” PMID 19101421 ↗ Jan 2009 |
| Target | NR3C1 | “Glucocorticoid receptor agonist” CHEMBL1201749 ↗ |