Drugs / Delgocitinib

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ANZUPGO 2025-07-23 fda.gov
Approved EU (EMA) Anzupgo 2024-09-19 europa.eu

Trials 23 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05050279 Sep 2021 → Jan 2022 LEO Pharma Completed No outcome recorded
Phase 14 trials
Phase 1 NCT05486117 Sep → Nov 2022 LEO Pharma Completed No outcome recorded
Phase 1 NCT04807751 Mar → Jul 2021 LEO Pharma Completed No outcome recorded
Phase 1 NCT04361136 Apr → May 2020 LEO Pharma Completed No outcome recorded
Phase 1 NCT03826901 Feb 2019 → Oct 2021 atopic eczema LEO Pharma Completed No outcome recorded
Phase 29 trials
Phase 2 NCT07671157 Sep 2026 → Oct 2027 expected frontal fibrosing alopecia Maryanne Makredes Senna Not yet recruiting No outcome recorded
Phase 2 NCT07487948 May 2026 → Apr 2027 expected central centrifugal cicatricial alopecia, lichen planopilaris Icahn School of Medicine at Mount Sinai Recruiting No outcome recorded
Phase 2 NCT07013201 Sep 2025 → Dec 2026 expected palmoplantar pustulosis LEO Pharma Recruiting No outcome recorded
Phase 2 NCT05332366 Apr 2022 → Feb 2023 frontal fibrosing alopecia LEO Pharma Completed No outcome recorded
Phase 2 NCT03958955 Jul 2019 → Apr 2020 discoid lupus erythematosus LEO Pharma Terminated No outcome recorded
Phase 2 NCT03725722 Dec 2018 → May 2020 atopic eczema LEO Pharma Completed No outcome recorded
Phase 2 NCT03683719 Nov 2018 → Mar 2020 LEO Pharma Completed No outcome recorded
Phase 2 NCT03325296 Oct 2017 → May 2018 alopecia areata LEO Pharma Terminated No outcome recorded
Phase 2 NCT02561585 Jan → Dec 2016 alopecia areata LEO Pharma Completed No outcome recorded
Phase 37 trials
Phase 3 NCT07335588 May 2026 → Mar 2028 expected lichen sclerosus et atrophicus LEO Pharma Recruiting No outcome recorded
Phase 3 NCT06004050 Sep 2023 → Dec 2024 LEO Pharma Completed No outcome recorded
Phase 3 NCT05355818 Jul 2022 → Dec 2024 LEO Pharma Completed No outcome recorded
Phase 3 NCT05259722 Jun 2022 → Nov 2023 LEO Pharma Completed No outcome recorded
Phase 3 NCT04949841 Aug 2021 → Sep 2023 LEO Pharma Completed No outcome recorded
Phase 3 NCT04872101 May 2021 → Dec 2022 LEO Pharma Completed No outcome recorded
Phase 3 NCT04871711 May 2021 → Oct 2022 LEO Pharma Completed No outcome recorded
Phase not applicable2 trials
NCT07203274 May → Dec 2026 expected Aalborg University Not yet recruiting No outcome recorded
NCT05120362 Nov 2021 → Mar 2023 acneiform dermatitis Shanghai East Hospital Unknown No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT02695940 Comparator Mar → Sep 2016 psoriasis LEO Pharma Completed No outcome recorded
Phase 2 NCT02664805 Comparator Feb → Jul 2016 LEO Pharma Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 27 sources stand behind the page.

FieldValueCited text
Known as Delgocitinib “In a pilot clinical trial (NCT05120362), 11 patients with EGFRi-induced rash were treated with delgocitinib ointment, resulting in improvement in rash severity by at least one...” PMID 38896602 Jun 2024
20

NCT05050279

NCT07671157

NCT04361136

NCT04871711

NCT07013201

NCT07335588

NCT03826901

NCT04949841

NCT03683719

NCT03958955

NCT03725722

NCT07203274

NCT04872101

NCT04807751

NCT05355818

NCT07487948

NCT06004050

NCT05259722

NCT05332366

NCT05486117

Known as JTE-052 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297507
Known as JTE-052A ChEMBL registry synonym — accepted as the source's own label CHEMBL4297507
Known as LEO 124249 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02561585
3

NCT02695940

NCT03325296

NCT02664805

Known as LEO 124249A ChEMBL registry synonym — accepted as the source's own label CHEMBL4297507
Action Inhibit “delgocitinib cream, a topical pan-Janus kinase (JAK) inhibitor” PMID 40186746 Apr 2025
Modality Small molecule CHEMBL4297507
Route Topical “twice-daily topical LEO 124249 30 mg/g ointment” NCT02561585
Target JAK1 “Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris” NCT07487948
Target TYK2 “Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris” NCT07487948