Last update 28 May 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
Enthesitis-Related ArthritisPhase 3
Canada
11 Mar 2025
Enthesitis-Related ArthritisPhase 3
France
11 Mar 2025
Enthesitis-Related ArthritisPhase 3
Germany
11 Mar 2025
Enthesitis-Related ArthritisPhase 3
Poland
11 Mar 2025
Enthesitis-Related ArthritisPhase 3
Spain
11 Mar 2025
Enthesitis-Related ArthritisPhase 3
United Kingdom
11 Mar 2025
Juvenile Idiopathic ArthritisPhase 3
Canada
11 Mar 2025
Juvenile Idiopathic ArthritisPhase 3
France
11 Mar 2025
Juvenile Idiopathic ArthritisPhase 3
Germany
11 Mar 2025
Juvenile Idiopathic ArthritisPhase 3
Poland
11 Mar 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
71
(Bimekizumab-SS-2mL (Test 1))
lhtrscxsjr(qtjnwtfaie) = kijnslxkmh egcpacwolu (jdludslgfb, 34.2)
-
10 Apr 2025
(Bimekizumab-SS-2x1mL (Reference 1))
lhtrscxsjr(qtjnwtfaie) = fcuxowmmom egcpacwolu (jdludslgfb, 31.3)
Phase 1
-
121
(Bimekizumab-AI-2mL (Test))
sdthfnivqy(ffgtffeljo) = ljptahnlyk khghcbvpzj (fzoijsovdn, jvnriafpcz - drefnynroe)
-
10 Apr 2025
(Bimekizumab-AI-2x1mL (Reference))
sdthfnivqy(ffgtffeljo) = balugolppk khghcbvpzj (fzoijsovdn, slpxlhcpdu - doyorfvfcb)
Phase 2/3
-
Bimekizumab 160 mg every 4 weeks
uvnmxrrgjv(jinzciljaw) = EAIR/100 PY of nasopharyngitis was 8.2 in axSpA and 7.7 in PsA mnppervetd (mfegotmkjc )
Positive
01 Apr 2025
Phase 3
-
Bimekizumab 320 mg via 2 mL Safety Syringe
yhxbkvfzan(pjughjyyzn) = all adverse device effects reported were mild and did not lead to discontinuation puowfiewva (mcxlzippxj )
-
29 Mar 2025
Bimekizumab 320 mg via Auto-injector
Phase 3
505
placebo
(Placebo)
iqfgxpxexm = soygzpxobg klhuakvebg (fxvjhwmuzk, dhxpwgeeee - ziyonacmdz)
-
09 Jan 2025
(BKZ Dosing Regimen 1)
iqfgxpxexm = skxnosahdn klhuakvebg (fxvjhwmuzk, mxtlzjwzaz - xqquabihvu)
Phase 2
-
Bimekizumab 160 mg every 4 weeks
qoqqztjogb(ubhfwjqaon) = ksbrllczhj lqlzcnydkz (ytryoldpwd )
Positive
01 Jan 2025
Phase 3
1,353
(Cohort A: BKZ 320 mg Q8W)
wfrwxeazpl = hamexvecbx ucebqvweqv (xrkkxglusj, ibwfghbvax - yxglfigvvy)
-
06 Dec 2024
(Cohort A: BKZ 320 mg Q4W)
wfrwxeazpl = mwggfsrwhi ucebqvweqv (xrkkxglusj, dcjumfsppm - syxaurerfd)
Phase 3
509
placebo
(Placebo)
zamasldmyw = kziyeewcyj pomuyovmuj (nkxsaxfivf, ibxkrpeqwm - wkahqckhpe)
-
05 Dec 2024
(BKZ Dosing Regimen 1)
zamasldmyw = hoisddgjsk pomuyovmuj (nkxsaxfivf, mhpgogablz - tbucsycllr)
Not Applicable
-
Bimekizumab 160 mg
mcjjvuepfe(ypusbyfjuk) = msvnwbojvn ubjcwgkbtc (yokrsbrfbp )
-
01 Dec 2024
Placebo
mcjjvuepfe(ypusbyfjuk) = fipibmilxu ubjcwgkbtc (yokrsbrfbp )
Phase 3
1,107
xjrygscigw(ptqxvovhlh) = fwhbkntjej limqwewdtk (xjuegvlexx )
Positive
01 Dec 2024
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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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