CLINICAL TRIALS PROFILE FOR CALCIPOTRIENE

505(b)(2) Clinical Trials for calcipotriene

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT02019355 ↗	Actinic Keratosis Study	Completed	Washington University School of Medicine	Early Phase 1	2013-10-01	The main purpose of this study is to determine the effectiveness of a new combination therapy for actinic keratosis. This study investigates a new indication for an FDA-approved topical medication, calcipotriol, for treatment of actinic keratosis, including how well it works and how safe it is when used in combination with the standard of care medication (5-fluorouracil) for the skin condition.
New Indication	NCT02019355 ↗	Actinic Keratosis Study	Completed	Washington University School of Medicine	Early Phase 1	2013-10-01	The main purpose of this study is to determine the effectiveness of a new combination therapy for actinic keratosis. This study investigates a new indication for an FDA-approved topical medication, calcipotriol, for treatment of actinic keratosis, including how well it works and how safe it is when used in combination with the standard of care medication (5-fluorouracil) for the skin condition.

All Clinical Trials for calcipotriene

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00279162 ↗	Efficacy and Safety of Calcipotriene/Betamethasone Gel/Ointment in Psoriasis	Completed	LEO Pharma	Phase 3	2005-12-01	Patients will receive either a gel containing both calcipotriene plus betamethasone or gel with no active ingredients as treatment for their scalp psoriasis for 8 weeks. After this time all patients will receive the gel containing both calcipotriene and betamethasone for 44 weeks. In addition, patients will receive an ointment containing both calcipotriene plus betamethasone as treatment for their psoriasis of the trunk and limbs for 52 weeks. The objective is to study the short-term efficacy of the gel, and the short and long-term safety of the gel and the ointment.
NCT00437255 ↗	Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis	Completed	Galderma Laboratories, L.P.	Phase 4	2006-08-01	Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.
NCT00608777 ↗	Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)	Terminated	Genentech, Inc.	Phase 4	2008-01-01	The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis. It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.
NCT00608777 ↗	Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)	Terminated	Derm Research, PLLC	Phase 4	2008-01-01	The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis. It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.

Clinical Trial Conditions for calcipotriene

Condition Name

Condition Name for calcipotriene
Intervention	Trials
Psoriasis	14
Plaque Psoriasis	6
Psoriasis Vulgaris	5
Nail Psoriasis	3

Condition MeSH

Condition MeSH for calcipotriene
Intervention	Trials
Psoriasis	30
Keratosis, Actinic	3
Keratosis	3
Carcinoma, Squamous Cell	2

Clinical Trial Locations for calcipotriene

Trials by Country

Trials by Country for calcipotriene
Location	Trials
United States	227
Canada	3
Israel	1
Germany	1

Trials by US State

Trials by US State for calcipotriene
Location	Trials
Texas	15
California	14
Florida	12
Kentucky	10
North Carolina	10

Clinical Trial Progress for calcipotriene

Clinical Trial Phase

Clinical Trial Phase for calcipotriene
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
Phase 4	12

Clinical Trial Status

Clinical Trial Status for calcipotriene
Clinical Trial Phase	Trials
Completed	24
Not yet recruiting	4
Recruiting	3

Clinical Trial Sponsors for calcipotriene

Sponsor Name

Sponsor Name for calcipotriene
Sponsor	Trials
LEO Pharma	7
Psoriasis Treatment Center of Central New Jersey	5
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for calcipotriene
Sponsor	Trials
Industry	37
Other	26
NIH	2

Last updated: July 28, 2026

Calcipotriene Clinical Trials Update, Market Analysis, and Launch Timeline Projections (2026)

Calcipotriene (calcipotriol; commonly marketed as topical vitamin D analogs) is positioned in dermatology for plaque psoriasis and related hyperproliferative skin disorders. Publicly available clinical-trial reporting and FDA commercialization status for “CALCIPOTRIENE” are not sufficiently mapped in the sources available to produce a complete, decision-grade update and market forecast.

What clinical trials are active or recruiting for calcipotriene in 2026?

Featured snippet answer: No complete, source-backed list of currently active or recruiting calcipotriene trials can be produced from the available information.

Which registries track calcipotriene studies?

• ClinicalTrials.gov (US)
• EU Clinical Trials Register (Europe)
• EudraCT-linked publications
• Sponsor press releases and conference abstracts

What trial endpoints matter for topical vitamin D analogs?

• PASI-75/PASI-90 (plaque psoriasis severity)
• IGA (Investigator’s Global Assessment)
• Time to onset and durability of response
• Skin tolerability (irritation, burning, erythema)
• Long-term safety (hypercalcemia risk monitoring in some protocols)

What is the market size for calcipotriene and related topical vitamin D analogs?

Featured snippet answer: A precise calcipotriene-specific market estimate cannot be produced from the available information.

How calcipotriene typically competes in the psoriasis topical market

Topical vitamin D analogs face competition from:

• Topical corticosteroids (including fixed-dose combinations)
• Topical calcineurin inhibitors (steroid-sparing, for select locations)
• PDE4 inhibitors and retinoids (depending on indication and formulation)
• Emerging topical combination strategies (vitamin D analog plus steroid)

Where revenue is usually concentrated

• Established Western markets with high psoriasis prevalence
• Dermatology-led formularies and payer step edits
• Genericized or off-patent segments where pricing pressure is strongest

When does calcipotriene lose exclusivity and what are the generic entry risks?

Featured snippet answer: A source-backed exclusivity and generic-entry risk timeline cannot be produced without a mapped patent and regulatory record for “CALCIPOTRIENE.”

What typically determines exclusivity for topical actives

• Composition-of-matter patents on the active
• Formulation and particle/crystal polymorph patents
• Method-of-use patents (dose regimens, combinations)
• Regulatory exclusivity (where applicable) tied to product-specific approvals
• Exclusivity fragmentation across dosage forms (cream, ointment, solution, foam, gel)

What patents protect calcipotriene (calcipotriol) and how strong is the estate?

Featured snippet answer: A patent landscape for “CALCIPOTRIENE” cannot be assembled to a litigation-grade standard from the available information.

What patent families are most common for topical vitamin D analogs

• Active synthesis and intermediates
• Salt/ester/prodrug variants (where applicable)
• Formulation patents (vehicle, stability, penetration enhancers)
• Combination patents (vitamin D analog plus corticosteroid)

What is the Orange Book status of calcipotriene topical products?

Featured snippet answer: Orange Book listings for “CALCIPOTRIENE” cannot be confirmed in the available information set.

How Orange Book data is used

• Determines branded versus generic approvals
• Identifies patent numbers listed per NDA/ANDA
• Flags potential Paragraph IV opportunities

What formulation patents protect calcipotriene creams, ointments, solutions, or foams?

Featured snippet answer: A formulation-level protection map cannot be produced without product-specific patent and regulatory linkage.

Common formulation protection themes

• Stability (light/oxygen/moisture)
• Skin permeation and vehicle selection
• Bioavailability and irritation profile optimization
• Preservative and pH window selection

What method-of-use patents exist for calcipotriene dosing regimens?

Featured snippet answer: Method-of-use coverage cannot be compiled from available information.

Dosing regimen concepts frequently claimed

• Frequency reduction strategies
• Step-down or maintenance protocols
• Combination regimens with topical corticosteroids
• Specific body-area dosing limits

What Paragraph IV challenges involve calcipotriene and what settlements affect market entry?

Featured snippet answer: A Paragraph IV and settlement timeline cannot be produced for “CALCIPOTRIENE” from the available information set.

What to look for in litigation dockets

• ANDA filer identities
• “Carve-outs” from product scope (strength, vehicle, dosing)
• Venue patterns (District Courts with patent-heavy caseloads)
• Expiration-based trigger dates tied to courts’ stay/lift orders

How do calcipotriene products compare with competing topical psoriasis drugs?

Featured snippet answer: A quantified comparative market and clinical positioning cannot be produced without calcipotriene-specific trial and product formulation comparators.

Competitor categories

• Vitamin D analogs (class competition)
• Steroid and steroid-combination topicals (high formulary share)
• Non-steroid anti-inflammatory topicals (where adopted)

What FDA pathways apply to calcipotriene products (NDA vs ANDA)?

Featured snippet answer: FDA pathway allocation for “CALCIPOTRIENE” cannot be confirmed from the available information.

What pathway mapping requires

• NDA/ANDA number per marketed strength and dosage form
• FDA approval letter and labeling
• Listed patents and exclusivity fields in the Orange Book

Key Takeaways

• A decision-grade clinical trials update and market projection for “CALCIPOTRIENE” cannot be completed from the currently available information.
• Producing defensible exclusivity, generic entry, and Orange Book status requires a mapped product-regulatory record that is not present in the available sources for this term.

FAQs

1. Is “calcipotriene” the same as calcipotriol in dermatology product labeling?
2. Which psoriasis subtypes have the strongest historical clinical evidence for topical vitamin D analogs?
3. What endpoints best predict durable real-world effectiveness for topical psoriasis actives?
4. How do combination products (vitamin D analog plus corticosteroid) change patent and generic entry risk?
5. What data fields in the Orange Book are most useful for forecasting launch dates and Paragraph IV timing?

References

1. No citable sources were provided in the available information set for “CALCIPOTRIENE” clinical trials, regulatory status, patent estate, or market sizing.