ALREX (loteprednol etabonate)
ALREX is indicated for the treatment of Allergic Conjunctivitis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-03-09
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
ALREX Approval History
What ALREX Treats
1 indicationsALREX is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Allergic Conjunctivitis
ALREX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ALREX
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04555694 results posted | TC-2020-DexRes | Ph 4 | completed | Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax |
| NCT01437982 | 628 | Ph 4 | completed | A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% |
| NCT01443442 results posted | MAC-06-11 | Ph 4 | completed | Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis |
| NCT01475643 results posted | 670 | Ph 3 | completed | Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children. |
| NCT03098953 | 881 | Ph 1 | completed | Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations |
| NCT01853696 results posted | 2013-0424 | Ph 4 | completed | Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty |
| NCT00699153 results posted | 526 | Ph 3 | completed | Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery |
| NCT00705159 results posted | 550 | Ph 4 | completed | Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis |
| NCT02028312 | CEI.HER-002 | Ph 4 | withdrawn | A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis® |
| NCT01724892 | othana001 | Ph 4 | completed | Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing |
| NCT01060072 results posted | 577 | Ph 3 | completed | Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery |
| NCT01010633 results posted | 576 | Ph 3 | completed | Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALREX FDA Label Details
Indications & Usage
FDA Label (PDF)ALREX is indicated for the treatment of Allergic Conjunctivitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment