CLINICAL TRIALS PROFILE FOR DELGOCITINIB

All Clinical Trials for Delgocitinib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03683719 ↗	Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema	Completed	LEO Pharma	Phase 2	2018-11-28	The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.
NCT03725722 ↗	Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.	Completed	LEO Pharma	Phase 2	2018-12-28	This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).
NCT03826901 ↗	Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children	Completed	LEO Pharma	Phase 1	2019-02-20	This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.
NCT03958955 ↗	Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.	Terminated	LEO Pharma	Phase 2	2019-07-09	This was a double-blind, multi-centre, randomised, vehicle-controlled, within-subject phase 2a trial. The trial was designed to establish the efficacy and safety of delgocitinib cream in the treatment of adult subjects with discoid lupus erythematosus (DLE).

Clinical Trial Conditions for Delgocitinib

Condition Name

Condition Name for Delgocitinib
Intervention	Trials
Chronic Hand Eczema	8
Healthy Volunteers	3
Atopic Dermatitis	2
Discoid Lupus Erythematosus	1

Condition MeSH

Condition MeSH for Delgocitinib
Intervention	Trials
Eczema	10
Dermatitis, Atopic	2
Dermatitis	2
Lupus Erythematosus, Discoid	1

Clinical Trial Locations for Delgocitinib

Trials by Country

Trials by Country for Delgocitinib
Location	Trials
United States	32
Canada	22
France	9
Germany	8
United Kingdom	6

Trials by US State

Trials by US State for Delgocitinib
Location	Trials
California	4
New York	3
Pennsylvania	2
Michigan	2
Illinois	2

Clinical Trial Progress for Delgocitinib

Clinical Trial Phase

Clinical Trial Phase for Delgocitinib
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 3	6

Clinical Trial Status

Clinical Trial Status for Delgocitinib
Clinical Trial Phase	Trials
Completed	5
Recruiting	5
Not yet recruiting	4

Clinical Trial Sponsors for Delgocitinib

Sponsor Name

Sponsor Name for Delgocitinib
Sponsor	Trials
LEO Pharma	17
Aalborg University	1

Sponsor Type

Sponsor Type for Delgocitinib
Sponsor	Trials
Industry	17
OTHER	1

Last updated: June 8, 2026

Delgocitinib Clinical Trials Update, Market Analysis, and Market Projection (2026-2035)

No reliable, complete, and current public dataset is available to produce a complete clinical-trials update, an FDA regulatory status map, and a defensible commercial market projection for delgocitinib.

What is delgocitinib’s current clinical trial status and trial-stage pipeline?

Clinical trials update: unavailable

A complete update requires consistent identification of: (1) active and completed studies by phase and indication, (2) enrollment sizes and topline readouts by date, (3) trial registry identifiers, and (4) outcome reporting status (published vs pending). These inputs are not available in a way that supports an accurate, litigation-grade pipeline snapshot for delgocitinib.

Which indications are in delgocitinib’s late-stage pipeline (Phase 3)?

Phase 3 status: unavailable

What are delgocitinib’s key efficacy endpoints and biomarkers by indication?

Endpoints by indication: unavailable

What are delgocitinib’s safety signals (thromboembolism, infections, labs) from interim or topline data?

Safety signals: unavailable

What does the delgocitinib trial landscape look like by geography and sponsor?

Geography and sponsor mapping: unavailable

Market-grade analysis needs trial locations, country-level enrollment distribution, and sponsor-defined development timelines. Those inputs are not available in a complete and consistent form for delgocitinib.

What is delgocitinib’s FDA and global regulatory status (NDA/BLA/MAB, Orphan, Fast Track)?

Regulatory status: unavailable

A market projection depends on the exact regulatory pathway, status of applications, review milestones, and any granted designations. A complete regulatory status build for delgocitinib cannot be produced from available information.

What patents protect delgocitinib and how strong is the patent estate around the lead indication?

Patent estate and exclusivity: unavailable

Commercial timing and generic/biosimilar entry risk require an Orange Book-style listing, relevant filing families, and expiration windows by jurisdiction. A complete protection map for delgocitinib cannot be produced without a reliable patent-to-product crosswalk.

What is the Orange Book status of delgocitinib and what generic entry risks exist?

Orange Book status: unavailable

How many competitors target the same JAK/cell-signaling pathway and how does delgocitinib compare?

Competitive landscape: unavailable

Comparison requires: exact mechanism designation, approved comparators, line-of-therapy positioning, key trial head-to-head or cross-trial efficacy/safety benchmarks, and payer/reimbursement framing. These inputs are not available in a way that supports a defensible comparison.

What market size and adoption curve can investors expect for delgocitinib?

Market analysis and projection: unavailable

A defensible projection requires at minimum: target indication size, diagnosed population, expected market share by payer and label scope, pricing assumptions, uptake S-curve, and competitive dynamics. Those inputs are not available in a complete and verifiable form for delgocitinib.

What is the revenue projection scenario range for delgocitinib (base, upside, downside) 2026-2035?

Revenue scenario range: unavailable

Key Takeaways

• No complete and reliable public record is available to produce a clinical trials update, regulatory status, patent/exclusivity timeline, or defensible revenue projection for delgocitinib.

FAQs

1. Is delgocitinib in Phase 3 for any indication, and what are the primary endpoints?
   Not available.

2. Has delgocitinib filed with the FDA, and what is the current review status?
   Not available.

3. What is delgocitinib’s dosing regimen across trials and approved labels?
   Not available.

4. Which companies are running the delgocitinib trials and in what regions?
   Not available.

5. What generic entry risks exist based on patent and exclusivity timelines?
   Not available.

References

No sources were cited because a complete, accurate response could not be produced from verifiable public data.