BYQLOVI (clobetasol propionate)
BYQLOVI is a corticosteroid used to manage recovery symptoms in patients who have recently undergone eye surgery. It helps patients with the swelling and discomfort that often follow these types of procedures. This medication treats both post-operative inflammation and the associated pain to support the healing process.
How BYQLOVI Works
This drug works by stimulating the production of proteins known as lipocortins, which inhibit the release of arachidonic acid. By blocking this precursor, the medication prevents the body from creating prostaglandins and leukotrienes, which are potent mediators of inflammation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-03-04
- Patent Cliff
- 2036
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
BYQLOVI Approval History
What BYQLOVI Treats
2 indicationsBYQLOVI is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammation
- Pain
BYQLOVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 BYQLOVI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02368886 results posted | RU021407I NCI-2015-00011, RU021407I | Ph 2 | completed | Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer |
| NCT05364515 PRGF | BTIIMD-01-EC/217LIQUEN | Ph 3 | withdrawn | Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva |
| NCT04364555 | LIKLO-1 | Ph 2, Ph 3 | active not recruiting | Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. |
| NCT05724446 CLOSE-3 | CLOBOF3-17IA03 | Ph 3 | recruiting | Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population |
| NCT04246801 CLOSE-1 results posted | CLOBOF3-16IA01 | Ph 3 | completed | Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1) |
| NCT04249076 CLOSE-2 results posted | CLOBOF3-16IA02 | Ph 3 | completed | Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2) |
| NCT03592342 | DT-001-R-004 | Ph 2 | completed | Intra-oral Treatment of OLP With Rivelin®-CLO Patches |
| NCT03535233 | AA22 | Ph 4 | completed | Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata |
| NCT02936492 | 17014 | Ph 1 | terminated | BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study |
| NCT01381445 | 113435 | Ph 1 | completed | A Study Assessing GW870086's Potential to Cause Skin Thinning |
| NCT02940002 | 17012 2016-000962-47 | Ph 1 | completed | BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test |
| NCT00828464 results posted | U0280-401 | Ph 4 | completed | Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis |
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.
BYQLOVI FDA Label Details
Indications & Usage
FDA Label (PDF)BYQLOVI is indicated for the treatment of Inflammation; Pain.
BYQLOVI Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for BYQLOVI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 2 active patents
Trial Analysis
- • 12 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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