Drugs / Bimekizumab

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Bimzelx 2021-08-20 europa.eu

Trials 51 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT07290036 Dec 2025 → May 2028 expected psoriatic arthritis, spondyloarthropathy UCB Biopharma SRL Recruiting No outcome recorded
Phase 1 NCT06888193 Nov 2025 → May 2027 expected hidradenitis suppurativa, psoriasis, psoriatic arthritis, spondyloarthropathy UCB Biopharma SRL Recruiting No outcome recorded
Phase 1 NCT03895385 Apr → Oct 2019 UCB Biopharma S.P.R.L. Completed No outcome recorded
Phase 1 NCT03707717 Oct 2018 → Jun 2019 UCB Biopharma S.P.R.L. Completed No outcome recorded
Phase 1 NCT05028127 Mar → Jun 2016 UCB Celltech Completed No outcome recorded
Phase 1 NCT02141763 May 2014 → Aug 2015 psoriatic arthritis UCB Celltech Completed No outcome recorded
Phase 1 NCT02529956 Nov 2012 → Jan 2014 psoriasis UCB Celltech Completed No outcome recorded
Phase 214 trials
Phase 2 NCT07138898 Dec 2025 → Jan 2028 expected rheumatic disorder NYU Langone Health Recruiting No outcome recorded
Phase 2 NCT06742333 Jul 2025 → Jul 2028 expected psoriasis Centre Hospitalier Universitaire de Nice Recruiting No outcome recorded
Phase 2 NCT04718896 Apr 2021 → Mar 2025 psoriasis UCB Biopharma SRL Completed No outcome recorded
Phase 2 NCT03355573 Nov 2017 → Oct 2022 ankylosing spondylitis UCB Biopharma SRL Completed No outcome recorded
Phase 2 NCT03347110 Nov 2017 → Oct 2020 psoriatic arthritis UCB Biopharma SRL Completed No outcome recorded
Phase 2 NCT03215277 Oct 2017 → May 2020 ankylosing spondylitis UCB Biopharma SRL Completed No outcome recorded
Phase 2 NCT03248531 Sep 2017 → Nov 2018 hidradenitis suppurativa UCB Biopharma SRL Completed No outcome recorded
Phase 2 NCT03230292 Jul 2017 → Mar 2019 psoriasis UCB Biopharma SRL Completed No outcome recorded
Phase 2 NCT03025542 Dec 2016 → Dec 2017 psoriasis UCB Biopharma SRL Completed No outcome recorded
Phase 2 NCT03010527 Dec 2016 → Sep 2018 psoriasis UCB Biopharma SRL Completed No outcome recorded
Phase 323 trials
Phase 3 NCT07219420 Nov 2025 → Dec 2027 expected palmoplantar pustulosis UCB Biopharma SRL Recruiting No outcome recorded
Phase 3 NCT06921850 Apr 2025 → Dec 2026 expected hidradenitis suppurativa UCB Biopharma SRL Recruiting No outcome recorded
Phase 3 NCT06668181 Mar 2025 → Apr 2028 expected enthesitis-related juvenile idiopathic arthritis, psoriasis-related juvenile idiopathic arthritis UCB Biopharma SRL Recruiting No outcome recorded
Phase 3 NCT06624228 Oct 2024 → Feb 2026 psoriatic arthritis UCB Biopharma SRL Completed No outcome recorded
Phase 3 NCT06506916 Jul 2024 → Mar 2027 expected psoriasis, psoriatic arthritis UCB Biopharma SRL Active not recruiting No outcome recorded
Phase 3 NCT06425549 Jun 2024 → Aug 2028 expected psoriasis UCB Biopharma SRL Recruiting No outcome recorded
Phase 3 NCT06011733 Oct 2023 → Feb 2025 psoriasis UCB Biopharma SRL Completed No outcome recorded
Phase 3 NCT05020249 Sep 2021 → Sep 2022 psoriasis UCB Biopharma SRL Completed No outcome recorded
Phase 3 NCT04901195 May 2021 → Jul 2026 overdue hidradenitis suppurativa UCB Biopharma SRL Active not recruiting No outcome recorded
Phase 3 NCT04436640 Jun 2020 → Aug 2026 overdue ankylosing spondylitis UCB Biopharma SRL Active not recruiting No outcome recorded
Phase 47 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 NCT07497620 Jul 2026 → Aug 2027 expected adult onset pityriasis rubra pilaris Mayo Clinic Not yet recruiting No outcome recorded
Phase 4 NCT07554014 Apr 2026 → Sep 2027 expected hidradenitis suppurativa Second Affiliated Hospital, School of Medicine, Zhejiang University Not yet recruiting No outcome recorded
Phase 4 NCT07149792 Jul 2025 → Dec 2026 expected psoriasis, psoriatic arthritis Taichung Veterans General Hospital Recruiting No outcome recorded
Phase 4 NCT06336343 Jun 2024 → Mar 2026 psoriasis Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 4 NCT05499416 Jan → Sep 2023 psoriasis, psoriatic arthritis Innovaderm Research Inc. Withdrawn No outcome recorded
Phase 4 NCT04340076 Aug 2020 → Jan 2025 psoriasis Radboud University Medical Center Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT04109976 Background Aug 2019 → Nov 2020 psoriatic arthritis UCB Biopharma SRL Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 58 sources stand behind the page.

FieldValueCited text
Known as bimekizumab bimekizumab, a humanised monoclonal IgG1 antibody” PMID 29275332 Dec 2017
51

Bimekizumab 120 mg + NAFL (1565 nm)” NCT07554014

bimekizumab (formerly UCB4940)” PMID 27859546 Jan 2017

Bimekizumab (Bimzelx)” NCT07149792

NCT03410992

NCT06336343

NCT04718896

NCT06011733

NCT07352566

NCT02905006

NCT07497620

NCT02969525

NCT03248531

NCT06742333

NCT03010527

NCT03025542

NCT02430909

NCT04436640

NCT04109976

NCT03928704

NCT06624228

NCT03536884

NCT03355573

NCT04009499

NCT03896581

NCT04242446

NCT07290036

NCT03895385

NCT03895203

NCT07138898

NCT03707717

NCT04340076

NCT06921850

NCT06506916

NCT03928743

NCT05028127

NCT06888193

NCT05020249

NCT03215277

NCT04901195

NCT03230292

NCT06668181

NCT05499416

NCT03370133

NCT03347110

NCT03598790

NCT02963506

NCT04242498

NCT03412747

NCT06425549

NCT07219420

NCT03766685

Known as Bimekizumab-bkzx ChEMBL registry synonym — accepted as the source's own label CHEMBL4297700
Known as Bimzelx “Bimekizumab (Bimzelx)” NCT07149792
Known as BKZ “Bimekizumab (BKZ), an IL-17A and IL-17F inhibitor, has demonstrated a rapid and high level of complete skin clearance in patients with psoriasis and complete normalization of...” PMID 41580158 Jan 2026
2

“OBJECTIVE: To assess the long-term safety profile of bimekizumab (BKZ) in patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).” PMID 40194794 Apr 2025

“Participants will receive bimekizumab (BKZ) at pre-specified time points.” NCT07290036

Known as UCB4940 “The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with...” NCT02430909
2

“* Active Substance: UCB4940NCT02141763

NCT02529956

Action Inhibit “Neutralisation of IL-17A and IL-17F with bimekizumab” PMID 29275332 Dec 2017
Modality Monoclonal antibody “bimekizumab, a humanised monoclonal IgG1 antibody” PMID 29275332 Dec 2017
Route Intravenous “Route of Administration: intravenousNCT02141763
Target IL17A “a monoclonal antibody that selectively neutralises IL17A and IL17F” PMID 32035552 Feb 2020
Target IL17F “a monoclonal antibody that selectively neutralises IL17A and IL17FPMID 32035552 Feb 2020