ENSTILAR (betamethasone dipropionate)
ENSTILAR is indicated for the treatment of Plaque Psoriasis.
How ENSTILAR Works
Enstilar Foam utilizes the combined pharmacological effects of calcipotriene hydrate, a synthetic vitamin D3 analog, and betamethasone dipropionate, a synthetic corticosteroid. While the exact mechanisms of action in treating plaque psoriasis are unknown, the therapeutic effect is attributed to the synergistic properties of these two active ingredients.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-10-16
- Patent Cliff
- 2031
- Routes
- TOPICAL
- Dosage Forms
- AEROSOL, FOAM
ENSTILAR Approval History
What ENSTILAR Treats
1 indicationsENSTILAR is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Plaque Psoriasis
ENSTILAR 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 ENSTILAR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05185258 MEMPSOLAR | MEMPSOLAR | Ph 4 | active not recruiting | Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study |
| NCT06332612 MROSF | 8420224AROM | Ph 1, Ph 2 | completed | Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial |
| NCT06329258 | PTC09 | Ph 4 | completed | Combination of Sotyktu and Enstilar for Plaque Psoriasis |
| NCT04580537 LAsED | LAsED 2019-002960-29, H-19047222 | Ph 2 | completed | Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails |
| NCT03848871 results posted | ENS-1702 | Ph 4 | completed | The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients |
| NCT04372277 | PTC06 | Ph 4 | recruiting | Taltz in Combination With Enstilar for Psoriasis |
| NCT03441789 results posted | ENS-1701 | Ph 4 | completed | Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis |
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.
ENSTILAR FDA Label Details
Indications & Usage
FDA Label (PDF)ENSTILAR is indicated for the treatment of Plaque Psoriasis.
ENSTILAR Patents & Exclusivity
Patents (10 active)
Pro Intelligence Preview
Deep insights for ENSTILAR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 11 active patents
Trial Analysis
- • 6 total trials
- • Stage: Mature
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