Drugs / Loteprednol
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT01721694 | Dec 2012 → Mar 2013 | bacterial conjunctivitis, blepharitis, keratitis | Adapt Produtos Oftalmológicos Ltda. | Withdrawn | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT07671222 Comparator | Dec 2026 → Mar 2028 expected | Sjogren syndrome, dry eye syndrome | Instituto de Oftalmología Fundación Conde de Valenciana | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT02974387 Comparator | Apr → Aug 2017 | — | Dr Salouti Eye Research Center | Unknown | No outcome recorded |
| Phase 4 | NCT01456780 Comparator | Aug 2011 → Mar 2013 | blepharitis | Massachusetts Eye and Ear Infirmary | Completed | No outcome recorded |
| Phase 4 | NCT01193504 Comparator | Sep 2010 → Oct 2012 | cataract | Innovative Medical | Unknown | No outcome recorded |
| Phase 4 | NCT00817557 Comparator | Jan → Jun 2009 | — | Hom, Milton M., OD, FAAO | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-07-01 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel lupin.com ↗
Mumbai, Naples, July 1, 2025: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Gel, 0.38%. |
| 2025-01-09 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel lupin.com ↗ |
| 2024-04-25 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Suspension, 0.5% lupin.com ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-07-16 | Lupin Limited | Lupin Launches Loteprednol Etabonate Ophthalmic Suspension, 0.5% in the United States lupin.com ↗ |
| 2025-07-01 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel lupin.com ↗ |
| 2025-01-09 | Lupin Limited | Lupin Receives Tentative Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel lupin.com ↗ |
| 2024-04-25 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Suspension, 0.5% lupin.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Loteprednol | “Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following...” NCT01193504 ↗ |
| Known as | Lotemax | “Loteprednol (Lotemax)” NCT02974387 ↗ |
| Action | Inhibit | “Loteprednol inhibits processes in the body that cause inflammation.” NCT01456780 ↗ |
| Modality | Other / unclassified | “steroid agents” NCT02974387 ↗ |
| Route | Topical | “Lotemax eye drops” NCT01193504 ↗ |