SORILUX (calcipotriene)
Sorilux is a topical foam used to manage plaque psoriasis on the scalp and body. It helps both adults and children as young as four years old who are dealing with this skin condition. As a vitamin D analog, it provides a localized option for patients needing to treat these specific areas.
How SORILUX Works
This medication works as a synthetic form of vitamin D3 that binds to receptors in the body much like natural vitamin D3 does. While its specific biological pathway for improving psoriasis symptoms is currently unknown, it mimics the binding activity of the natural vitamin.
Details
- Status
- Prescription
- First Approved
- 2010-10-06
- Patent Cliff
- 2028
- Routes
- TOPICAL
- Dosage Forms
- AEROSOL, FOAM
SORILUX Approval History
What SORILUX Treats
1 indicationsSORILUX is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Plaque Psoriasis
SORILUX 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.
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 SORILUX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT05699603 | NCI-2023-00310 P30CA023074, UG1CA242596 | Ph 2 | active not recruiting | Testing the Efficacy of Topical Calcipotriene Plus 5-Fluorouracil Combination to Activate the Immune System Against Precancerous Skin Lesions in Organ Transplant Recipients |
| NCT03370406 | STUDY19090229 5P50CA121973-10 | Ph 1 | recruiting | Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC |
| NCT01188928 results posted | LEO 80185-G23 | Ph 3 | completed | LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs) |
| NCT01268527 results posted | E6201-E044-204 2009-014815-11 | Ph 2 | completed | A 12-Day Randomized, Blinded, Vehicle and Active Comparator-Controlled Study to Determine the Efficacy and Safety of Six Concentrations of Topical E6201 Gel in Subjects With Psoriasis Vulgaris |
| NCT01694433 results posted | 1R01AR053542-01A2 1R01AR053542-01A2 | Ph 2, Ph 3 | completed | "Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy" |
| NCT03448081 | SNA-120-202 | Ph 2 | completed | Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene |
| NCT02680717 | 730382-2 | Ph 1 | withdrawn | Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea |
| NCT01745133 results posted | OLX0112 | Ph 4 | completed | Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response 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.
SORILUX FDA Label Details
Indications & Usage
FDA Label (PDF)SORILUX is indicated for the treatment of Plaque Psoriasis.
Pro Intelligence Preview
Deep insights for SORILUX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 5 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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.