Delgocitinib (JTE-052) Clinical Trials

Size	Price	Qty
2mg	USD 347
5mg	USD 699

Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 3 evaluate the therapeutic application of topical delgocitinib across various dermatological and inflammatory conditions, including chronic hand eczema, atopic dermatitis, palmoplantar pustulosis, mycosis fungoides, frontal fibrosing alopecia, and discoid lupus erythematosus. Sponsored by industry leaders such as LEO Pharma alongside academic institutions including Aarhus University Hospital and the Icahn School of Medicine at Mount Sinai, these studies represent recruitment statuses ranging from completed and actively recruiting to upcoming and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07781449	NOT_YET_RECRUITING	Mycosis Fungoides; Cutaneous T-cell Lymphoma	Aarhus University Hospital	2026-09	PHASE2
NCT07335588	RECRUITING	Lichen Sclerosus	LEO Pharma	2026-05-01	PHASE3
NCT07671157	NOT_YET_RECRUITING	Frontal Fibrosing Alopecia	Maryanne Makredes Senna	2026-09-10	PHASE2
NCT07487948	RECRUITING	Central Centrifugal Cicatricial Alopecia; Lichen Planopilaris	Icahn School of Medicine at Mount Sinai	2026-05-19	PHASE2
NCT07203274	NOT_YET_RECRUITING	Itchiness	Aalborg University	2026-05-01
NCT07013201	RECRUITING	Palmoplantar Pustulosis	LEO Pharma	2025-09-11	PHASE2
NCT06004050	COMPLETED	Chronic Hand Eczema	LEO Pharma	2023-09-05	PHASE3
NCT05355818	COMPLETED	Chronic Hand Eczema	LEO Pharma	2022-07-14	PHASE3
NCT05259722	COMPLETED	Chronic Hand Eczema	LEO Pharma	2022-06-15	PHASE3
NCT04949841	COMPLETED	Chronic Hand Eczema	LEO Pharma	2021-08-23	PHASE3
NCT05332366	COMPLETED	Frontal Fibrosing Alopecia	LEO Pharma	2022-04-19	PHASE2
NCT04872101	COMPLETED	Chronic Hand Eczema	LEO Pharma	2021-05-25	PHASE3
NCT05486117	COMPLETED	Chronic Hand Eczema	LEO Pharma	2022-09-06	PHASE1
NCT04871711	COMPLETED	Chronic Hand Eczema	LEO Pharma	2021-05-10	PHASE3
NCT05050279	COMPLETED	Healthy	LEO Pharma	2021-09-29	EARLY_PHASE1
NCT03826901	COMPLETED	Atopic Dermatitis	LEO Pharma	2019-02-20	PHASE1
NCT04807751	COMPLETED	Healthy	LEO Pharma	2021-03-25	PHASE1
NCT04361136	COMPLETED	Healthy	LEO Pharma	2020-04-23	PHASE1
NCT03725722	COMPLETED	Atopic Dermatitis	LEO Pharma	2018-12-28	PHASE2
NCT03958955	TERMINATED	Discoid Lupus Erythematosus	LEO Pharma	2019-07-09	PHASE2
NCT03683719	COMPLETED	Chronic Hand Eczema	LEO Pharma	2018-11-28	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the Delgocitinib (JTE-052) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Delgocitinib is a pan-Janus kinase inhibitor that potently binds JAK1, JAK2, JAK3, and Tyk2, thereby blocking intracellular STAT phosphorylation and preventing downstream inflammatory cytokine signaling cascades. This inhibition suppresses hyperactive local immune responses, mitigating tissue inflammation and providing clinical relevance in dermatological conditions such as chronic hand eczema and atopic dermatitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).