Drugs / Nemolizumab

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Nemluvio 2025-02-12 europa.eu

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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05405985 Aug → Nov 2022 Galderma R&D Completed No outcome recorded
Phase 211 trials
Phase 2 NCT07704775 Sep 2026 → Sep 2027 expected vulvar lichen sclerosus University of Texas Southwestern Medical Center Not yet recruiting No outcome recorded
Phase 2 NCT07660835 Jun 2026 → Jul 2028 expected atopic eczema Galderma R&D Not yet recruiting No outcome recorded
Phase 2 NCT07047690 Feb 2026 → May 2028 expected systemic sclerosis Galderma R&D Recruiting No outcome recorded
Phase 2 NCT07074977 Oct 2025 → Sep 2026 expected Galderma R&D Recruiting No outcome recorded
Phase 2 NCT05214794 Apr 2022 → Jun 2024 systemic sclerosis Maruho Co., Ltd. Completed No outcome recorded
Phase 2 NCT04921345 Jun 2021 → Apr 2025 atopic eczema Galderma R&D Completed No outcome recorded
Phase 2 NCT04365387 Mar 2020 → Jul 2023 atopic eczema Galderma R&D Completed No outcome recorded
Phase 2 NCT03921411 Apr 2019 → Aug 2020 atopic eczema Galderma R&D Completed No outcome recorded
Phase 2 NCT03181503 Oct 2017 → Sep 2018 prurigo nodularis Galderma R&D Completed No outcome recorded
Phase 2 NCT03100344 Jun 2017 → Jul 2018 atopic eczema Galderma R&D Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05075408 Mar 2022 → Jan 2024 Galderma R&D Completed No outcome recorded
Phase 38 trials
Phase 3 NCT05056779 Jan → Jul 2023 atopic eczema Galderma R&D Withdrawn No outcome recorded
Phase 3 NCT05052983 Jan 2022 → Sep 2023 prurigo nodularis Galderma R&D Completed No outcome recorded
Phase 3 NCT04204616 Jan 2021 → Oct 2026 expected prurigo nodularis Galderma R&D Active not recruiting No outcome recorded
Phase 3 NCT04501666 Sep 2020 → Nov 2022 prurigo nodularis Galderma R&D Completed No outcome recorded
Phase 3 NCT04501679 Aug 2020 → Mar 2022 prurigo nodularis Galderma R&D Completed No outcome recorded
Phase 3 NCT03989206 Dec 2019 → Aug 2026 overdue atopic eczema Galderma R&D Active not recruiting No outcome recorded
Phase 3 NCT03989349 Jun 2019 → Feb 2022 atopic eczema Galderma R&D Completed No outcome recorded
Phase 3 NCT03985943 Jun 2019 → Dec 2021 atopic eczema Galderma R&D Completed No outcome recorded
Phase 42 trials
Phase 4 NCT07352566 Aug 2026 → Jun 2030 expected atopic eczema, psoriasis University of California, San Francisco Not yet recruiting No outcome recorded
Phase 4 NCT07396168 Feb 2026 → Jun 2027 expected lichen planopilaris The Skin Center Dermatology Group Recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT04562116 Background Dec 2021 → Jun 2023 atopic eczema Galderma R&D Completed No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 28 sources stand behind the page.

FieldValueCited text
Known as Nemolizumab “A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)” NCT03181503
23

NCT04501679

NCT05075408

NCT07074977

NCT04204616

NCT05405985

NCT01986933

NCT05052983

NCT03921411

NCT03989349

NCT04365387

NCT07704775

NCT07352566

NCT04921345

NCT05056779

NCT07396168

NCT07660835

NCT05214794

NCT03985943

NCT03989206

NCT03100344

NCT04501666

NCT07047690

NCT04562116

Known as CD14152 “The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent...” NCT04365387
1

“A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)” NCT03181503

Known as CIM331 “We wanted to assess the efficacy and safety of nemolizumab (CIM331), a humanized antibody against interleukin-31 receptor A” PMID 28249150 Mar 2017
Known as Nemluvio ChEMBL registry synonym — accepted as the source's own label CHEMBL4297794
Known as Nemolizumab-ilto ChEMBL registry synonym — accepted as the source's own label CHEMBL4297794
Action Inhibit “Nemolizumab, an interleukin (IL)-31 receptor subunit α antagonist, inhibits the IL-31 pathway of itch and skin inflammation in atopic dermatitis.” PMID 39067461 Jul 2024
Modality Monoclonal antibody “Nemolizumab, an anti-IL-31 receptor A mAb” PMID 29753033 May 2018
Route Subcutaneous “receive subcutaneous nemolizumab” PMID 28249150 Mar 2017
Target IL31RA “Nemolizumab, an interleukin (IL)-31 receptor subunit α antagonist, inhibits the IL-31 pathway of itch and skin inflammation in atopic dermatitis.” PMID 39067461 Jul 2024