Drugs / Delgocitinib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed eczematous dermatitis of eyelid 2 milestones | |||||
| Filed | US (FDA) | Anzupgo® | eczematous dermatitis of eyelid | 2024-07-31 | “the filing of a New Drug Application (NDA) for delgocitinib cream with the Food and Drug Administration (FDA) in the U.S.” leo-pharma.com ↗ |
| Filed | EU (EMA) | — | eczematous dermatitis of eyelid | 2023-03-09 | “delgocitinib, in treating moderate-to-severe chronic hand eczema and submitted a marketing authorization application to EMA.” leo-pharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | ANZUPGO | — | 2025-07-23 | fda.gov ↗ |
| Approved | EU (EMA) | Anzupgo | — | 2024-09-19 | europa.eu ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 210 trials · 2 met primary · 2 missed | ||||||
| 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 | NCT07820098 | Apr 2026 → Apr 2027 expected | vitiligo | Lone Skov | Active not 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 | Missed primary Stop: Enrollment |
| Phase 2 | NCT03725722 | Dec 2018 → May 2020 | atopic eczema | LEO Pharma | Completed | Met primary |
| Phase 2 | NCT03683719 | Nov 2018 → Mar 2020 | — | LEO Pharma | Completed | Met primary |
| 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 | Missed primary |
| Phase 37 trials · 4 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT05259722 | Jun 2022 → Nov 2023 | — | LEO Pharma | Completed | Met primary |
| Phase 3 | NCT04949841 | Aug 2021 → Sep 2023 | — | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT04872101 | May 2021 → Dec 2022 | — | LEO Pharma | Completed | Met primary |
| Phase 3 | NCT04871711 | May 2021 → Oct 2022 | — | LEO Pharma | Completed | Met primary |
| 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 |
| Comparator or background therapy2 trials | ||||||
| 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 |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | LEO Pharma | Results LEO Pharma presents new data on delgocitinib cream at EADV 2026 highlighting real-world outcomes in adults and new adolescent data in Chronic Hand Eczema (CHE) leo-pharma.com ↗
New post hoc analyses from the phase 3 DELTA TEEN trial show greater reductions in daily HESD itch and pain scores with delgocitinib cream than with cream vehicle in adolescents aged 12-17 with moderate to severe CHE. |
| 2026-09-18 | LEO Pharma | Regulatory LEO Pharma receives positive CHMP opinion recommending Anzupgo® (delgocitinib) cream for adolescents with moderate to severe chronic hand eczema in the EU leo-pharma.com ↗
The Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the use of Anzupgo® (delgocitinib) cream to adolescents aged 12 to 17 years with moderate to severe chronic hand eczema for whom topical corticosteroids are inadequate or inappropriate. |
| 2026-06-25 | LEO Pharma | Results LEO Pharma to showcase new data highlighting the burden and unmet needs in Chronic Hand Eczema at ESCD 2026 in Copenhagen leo-pharma.com ↗
Patient reported outcomes from DELTA FORCE further demonstrated greater improvements in self-rated work productivity and daily activities in patients treated with topical delgocitinib compared with patients treated with oral alitretinoin. |
| 2026-02-27 | Shionogi | Regulatory Application for Manufacturing and Marketing Approval of a New Lotion Formulation for the Atopic Dermatitis Treatment "CORECTIM®" in Japan shionogi.com ↗
This application for approval of the additional formulation is based on the positive results of a Phase 1 skin safety study (jRCT2031230570) and a Phase 3 bioequivalence study (jRCT2031230713). |
All press releases naming this drug 10 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited 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 |
| Known as | Anzupgo | “The treatment being tested is a cream called Anzupgo, which contains an active ingredient named delgocitinib.” NCT07820098 ↗ |
| 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 NCT03325296 ↗ |
| 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 ↗ |