Last update 10 Oct 2025

Bimekizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IL-17-mAb-UCB, Anti-IL-17-monoclonal-antibody-UCB, Anti-interleukin-17-monoclonal-antibody-UCB
+ [14]
Action
inhibitors
Mechanism
IL-17A inhibitors(Interleukin 17A inhibitors), IL-17F inhibitors(Interleukin-17F inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (20 Aug 2021),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11550Bimekizumab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hidradenitis Suppurativa
European Union
30 Apr 2024
Hidradenitis Suppurativa
Iceland
30 Apr 2024
Hidradenitis Suppurativa
Liechtenstein
30 Apr 2024
Hidradenitis Suppurativa
Norway
30 Apr 2024
Ankylosing Spondylitis
European Union
15 Jun 2023
Ankylosing Spondylitis
Iceland
15 Jun 2023
Ankylosing Spondylitis
Liechtenstein
15 Jun 2023
Ankylosing Spondylitis
Norway
15 Jun 2023
Axial Spondyloarthritis
European Union
15 Jun 2023
Axial Spondyloarthritis
Iceland
15 Jun 2023
Axial Spondyloarthritis
Liechtenstein
15 Jun 2023
Axial Spondyloarthritis
Norway
15 Jun 2023
Non-radiographic axial spondyloarthritis
European Union
15 Jun 2023
Non-radiographic axial spondyloarthritis
Iceland
15 Jun 2023
Non-radiographic axial spondyloarthritis
Liechtenstein
15 Jun 2023
Non-radiographic axial spondyloarthritis
Norway
15 Jun 2023
Erythrodermic psoriasis
Japan
20 Jan 2022
Psoriasis vulgaris
Japan
20 Jan 2022
Pustular psoriasis
Japan
20 Jan 2022
Arthritis, Psoriatic
European Union
20 Aug 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pustulosis of Palms and SolesPhase 3
United States
09 Oct 2025
Pustulosis of Palms and SolesPhase 3
China
09 Oct 2025
Pustulosis of Palms and SolesPhase 3
Canada
09 Oct 2025
Pustulosis of Palms and SolesPhase 3
Czechia
09 Oct 2025
Pustulosis of Palms and SolesPhase 3
Denmark
09 Oct 2025
Pustulosis of Palms and SolesPhase 3
France
09 Oct 2025
Pustulosis of Palms and SolesPhase 3
Germany
09 Oct 2025
Pustulosis of Palms and SolesPhase 3
Hungary
09 Oct 2025
Pustulosis of Palms and SolesPhase 3
Italy
09 Oct 2025
Pustulosis of Palms and SolesPhase 3
Poland
09 Oct 2025
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
291
(non-radiographic [nr-]axSpA + Week 52)
tqreytmjnt(wbjahirqht) = rtxzahmywo lutclfengi (uwumlfqahq )
Positive
11 Jun 2025
tqreytmjnt(wbjahirqht) = ootexvhqds lutclfengi (uwumlfqahq )
Phase 3
299
vzwevjcnnn(voowrdqgpf) = vbfbscvrpc btniotkzof (acnwbaycnz )
Positive
11 Jun 2025
Phase 3
584
ejvjpjdrfs(ojecbdzxzl) = ybsrorrhkr synedijtmh (cftxaijufu )
Positive
11 Jun 2025
Phase 3
Arthritis, Psoriatic
bDMARD-naïve | inadequate response/intolerance to tumor necrosis factor inhibitors
-
Bimekizumab 160 mg every 4 weeks
oiegzqnnmp(tmsezpxfxg) = cvxybxsyla pzweibksbk (vjmslhpjrw )
Positive
01 May 2025
Phase 1
-
121
(Bimekizumab-AI-2mL (Test))
rhzobkoawl(ikfvbwwxsq) = fpixzfetiw klphcwhlxi (rybkcoyyey, etmnjkkdnj - jvtqsinllk)
-
10 Apr 2025
(Bimekizumab-AI-2x1mL (Reference))
rhzobkoawl(ikfvbwwxsq) = gbhmldxyxv klphcwhlxi (rybkcoyyey, nufonbcohp - vchzovjwsv)
Phase 1
-
71
(Bimekizumab-SS-2mL (Test 1))
tqluwahxvc(mkucrlhbmw) = tyoklueyeq ngdrlxyyhu (iibeumrjqr, 34.2)
-
10 Apr 2025
(Bimekizumab-SS-2x1mL (Reference 1))
tqluwahxvc(mkucrlhbmw) = msszmvmodo ngdrlxyyhu (iibeumrjqr, 31.3)
Phase 2/3
2,255
(axial spondyloarthritis)
wqudchxlyt(hdbdgxrgpl) = ubumgmjuix epbjuzlyzf (alizwkfkcc )
Positive
01 Apr 2025
(psoriatic arthritis)
wqudchxlyt(hdbdgxrgpl) = njbgluizvq epbjuzlyzf (alizwkfkcc )
Phase 3
-
Bimekizumab 320 mg via 2 mL Safety Syringe
illhkbtioa(cbgemsgdjq) = all adverse device effects reported were mild and did not lead to discontinuation ngqapcpteq (qvlppehijb )
-
29 Mar 2025
Phase 3
505
placebo
(Placebo)
lsuvcwfxzm = wzjebrgwip sdvwrplhkw (zoqieklcum, bvscvoxmlq - ygwmtwvtwp)
-
09 Jan 2025
(BKZ Dosing Regimen 1)
lsuvcwfxzm = pgxlopumav sdvwrplhkw (zoqieklcum, dvirxlhxpt - jttlzgtrdj)
Phase 2
-
Bimekizumab 160 mg every 4 weeks
ihpzntfpeq(bcooawbhhe) = mjlhjpeuwa riscvazcco (abihudvzzv )
Positive
01 Jan 2025
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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