CLINICAL TRIALS PROFILE FOR SORILUX

All Clinical Trials for SORILUX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01563068 ↗	Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis	Completed	GlaxoSmithKline	Phase 1	2012-04-01	Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study in which adolescent subjects (ages 12 to 16 years, inclusive) or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14 days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated
NCT01563068 ↗	Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis	Completed	Mayne Pharma International Pty Ltd	Phase 1	2012-04-01	Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study in which adolescent subjects (ages 12 to 16 years, inclusive) or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14 days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated
NCT01563068 ↗	Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis	Completed	Stiefel, a GSK Company	Phase 1	2012-04-01	Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study in which adolescent subjects (ages 12 to 16 years, inclusive) or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14 days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated
NCT01582932 ↗	Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis	Completed	GlaxoSmithKline	Phase 1	2013-04-01	Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study evaluating calcipotriene foam, 0.005% in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. Subjects or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer twice a day on the body and scalp for up to 8 weeks. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated.
NCT01582932 ↗	Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis	Completed	Mayne Pharma International Pty Ltd	Phase 1	2013-04-01	Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study evaluating calcipotriene foam, 0.005% in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. Subjects or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer twice a day on the body and scalp for up to 8 weeks. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated.
NCT01745133 ↗	Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis	Completed	Stiefel, a GSK Company	Phase 4	2013-01-01	The purpose of the study is to investigate if combined use of OLUX-E™ Foam and SORILUX Foam may help "maintain" the therapeutic benefit that is achieved with OLUX-E™ Foam in the treatment of moderate plaque psoriasis. OLUX-E™ is a medication that contains a corticosteroid delivered in a foam formulation. SORILUX Foam is a foam formulation of calcipotriene. Both medications have been approved by the FDA for treating plaque psoriasis.
NCT01745133 ↗	Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis	Completed	Leon Kircik, M.D.	Phase 4	2013-01-01	The purpose of the study is to investigate if combined use of OLUX-E™ Foam and SORILUX Foam may help "maintain" the therapeutic benefit that is achieved with OLUX-E™ Foam in the treatment of moderate plaque psoriasis. OLUX-E™ is a medication that contains a corticosteroid delivered in a foam formulation. SORILUX Foam is a foam formulation of calcipotriene. Both medications have been approved by the FDA for treating plaque psoriasis.

Clinical Trial Conditions for SORILUX

Condition Name

Condition Name for SORILUX
Intervention	Trials
Psoriasis	3
Plaque Psoriasis	1
Actinic Keratoses	1

Condition MeSH

Condition MeSH for SORILUX
Intervention	Trials
Psoriasis	4
Keratosis, Actinic	1
Keratosis	1

Clinical Trial Locations for SORILUX

Trials by Country

Trials by Country for SORILUX
Location	Trials
United States	29

Trials by US State

Trials by US State for SORILUX
Location	Trials
Kentucky	3
Texas	2
Pennsylvania	2
Indiana	2
Illinois	2

Clinical Trial Progress for SORILUX

Clinical Trial Phase

Clinical Trial Phase for SORILUX
Clinical Trial Phase	Trials
Phase 4	2
Phase 1	2
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for SORILUX
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for SORILUX

Sponsor Name

Sponsor Name for SORILUX
Sponsor	Trials
GlaxoSmithKline	3
Mayne Pharma International Pty Ltd	3
Stiefel, a GSK Company	2

Sponsor Type

Sponsor Type for SORILUX
Sponsor	Trials
Industry	8
Other	3

SORILUX (calcipotriene/betamethasone) clinical trials update, market analysis, and projection: pipeline, uptake drivers, and exclusivity risks

Last updated: June 3, 2026

What is SORILUX and what clinical evidence supports its current use?

SORILUX is a topical fixed-dose combination of calcipotriene (vitamin D analog) and betamethasone (corticosteroid) indicated for plaque psoriasis. It is positioned against other topical vitamin D and steroid regimens, with differentiated value from combination dosing that can improve adherence versus monotherapy sequences.

What were the pivotal Phase 3 efficacy endpoints?

SORILUX’s approval evidence traces to company development programs for topical calcipotriene-betamethasone combinations. Across the topical psoriasis class, the standard primary and secondary endpoints used in pivotal trials include:

• Investigator’s Global Assessment (IGA) achievement of clear-to-minimal disease
• Psoriasis Area and Severity Index (PASI) change from baseline (often including PASI 75 response as a key comparator)
• Time to onset and durability during maintenance or follow-up windows

What safety endpoints matter for adoption?

In topical steroid-containing products, clinical adoption tracks with:

• Rates of local adverse reactions (burning, erythema, pruritus)
• Skin atrophy signals and steroid-class risk mitigation
• Systemic exposure concerns (relevant for extensive use and occlusion, though topical fixed-dose products manage risk via labeling restrictions)

What clinical trials for SORILUX are active or completed, and what are the latest updates?

No complete, up-to-date trial-by-trial status can be produced from the information available in this chat context.

Which companies compete with SORILUX in topical plaque psoriasis and how does SORILUX compare?

SORILUX competes in a crowded topical psoriasis market dominated by:

• Fixed-dose calcipotriene-betamethasone combinations (multiple branded and authorized generics)
• Topical vitamin D analogs (e.g., calcipotriene, calciopotriol) in cream/solution formats
• Topical corticosteroids including high-potency classes
• Topical calcineurin inhibitors and newer combinations in overlapping subsegments

How does SORILUX’s value proposition translate into formulary wins?

Formulary uptake and payer coverage in topical psoriasis is driven by:

• Cost per day and patient share rules
• Prior authorization requirements, step edits, and quantity limits
• Demonstrated effectiveness on IGA and PASI endpoints in the approved severity range
• Patient preference for vehicle (foam/solution/gel/ointment) which can affect adherence, especially for scalp involvement

What is the current market size and pricing trajectory for topical plaque psoriasis where SORILUX sits?

No complete, source-cited market sizing and pricing trajectory can be produced from the information available in this chat context.

When does SORILUX lose exclusivity, and what generic entry risks exist?

Exclusivity and patent-risk assessment requires Orange Book patent mappings and associated expiration and challenge timelines. No Orange Book listing or patent expiration data is available in this chat context, so a complete exclusivity loss and generic entry risk profile cannot be produced.

What is the Orange Book status of SORILUX and how many patents cover it?

A patent-bundle count and strength assessment requires:

• FDA Orange Book publication details
• Listed patents, expiration dates, and protection categories
• Any Paragraph IV certifications and litigation outcomes tied to those patents

No Orange Book data is available in this chat context, so the requested status and counts cannot be compiled.

How many SORILUX formulations are marketed and what delivery systems influence adoption?

No product-portfolio details (strengths, vehicles, package sizes, and marketed presentations) can be verified from this chat context.

How does SORILUX compare with calcipotriene-betamethasone alternatives, including generics and authorized brands?

A competitive head-to-head assessment requires:

• Specific marketed comparators (brand vs authorized generic)
• Strength and vehicle equivalence
• Pricing and market share by NDC and channel No such dataset is available in this chat context.

What litigation, Paragraph IV challenges, or settlements affect SORILUX’s commercialization?

Patent litigation timelines and settlement terms require case dockets or litigating parties tied to SORILUX Orange Book patents. No such information is available in this chat context.

How should investors and business teams project SORILUX revenue over the next 3–7 years?

A forward projection requires inputs that are not present here:

• Current net sales by year
• Channel mix (retail, specialty, PBM coverage)
• Gross-to-net assumptions (rebates, discounts, co-pay support)
• Competitive entry schedule (generics, authorized generics, switching behavior)
• Capacity and distribution constraints

No complete projection can be produced from this chat context without inventing non-provided metrics.

Key Takeaways

• SORILUX is a topical fixed-dose calcipotriene-betamethasone product in plaque psoriasis with clinical value rooted in combination vitamin D analog plus corticosteroid effects.
• The request requires up-to-date trial status, Orange Book exclusivity and patent listings, litigation outcomes, and market share/price data to support credible clinical and commercial projections.
• Those source elements are not present in the available context, so a complete clinical-trials update, market analysis, and revenue projection cannot be delivered without fabricating data.

FAQs

1. What is the mechanism of action of SORILUX for plaque psoriasis?
2. Does SORILUX have specific dosing guidance by severity or body area?
3. How does switching between topical calcipotriene-betamethasone products affect treatment adherence?
4. What safety monitoring is recommended for topical vitamin D analog plus corticosteroid combinations?
5. What factors most influence payer formulary coverage for topical psoriasis therapies?

References

No sources were provided in the prompt, and no source-cited data can be generated reliably from the available chat context.