DUOBRII (halobetasol propionate)
DUOBRII is indicated for the treatment of Plaque Psoriasis.
How DUOBRII Works
DUOBRII functions through the synergistic effects of two components. Halobetasol propionate is a corticosteroid that modulates cellular signaling, immune function, and inflammatory pathways, though its precise mechanism in psoriasis remains unknown. Tazarotene is a retinoid prodrug converted to tazarotenic acid, which binds to retinoic acid receptors (RARα, RARβ, and RARγ), with relative selectivity for RARβ and RARγ. This binding modifies gene expression related to cell proliferation and inflammation, though the clinical significance of these specific receptor interactions is unknown.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-04-25
- Patent Cliff
- 2036
- Routes
- TOPICAL
- Dosage Forms
- LOTION
DUOBRII Approval History
What DUOBRII Treats
1 indicationsDUOBRII is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Plaque Psoriasis
DUOBRII 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 DUOBRII
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05608499 results posted | GCO-22-0955 | Ph 3 | terminated | Duobrii Treatment of Acne Keloidalis Nuchae (AKN) |
| NCT03298581 | 71542610 | Ph 2 | withdrawn | Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis |
| NCT04119102 | PTC07 | Ph 4 | recruiting | Duobrii in Combination With Biologics |
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.
DUOBRII FDA Label Details
Indications & Usage
FDA Label (PDF)DUOBRII is indicated for the treatment of Plaque Psoriasis.
DUOBRII Patents & Exclusivity
Patents (10 active)
Pro Intelligence Preview
Deep insights for DUOBRII
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 10 active patents
Trial Analysis
- • 3 total trials
- • Stage: Expansion
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