Drug

Bimekizumab

Approved · EMA

Actively researchedLate-stage developmentSteady momentum

Also known as Bimzelx.

RxNorm2668041UNII09495UIM6V

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Clinical trial2026-07-28Primary completion · ClinicalTrials.gov

A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis

Clinical trial2026-07-17Results expected Q3 2026 · ClinicalTrials.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study With Open-Label Extension to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis

Clinical trial2026-07-17Results expected Q4 2027 · ClinicalTrials.gov

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

Clinical trial2026-07-06Results expected Q2 2028 · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis

Clinical trial2026-06-26Results posted · ClinicalTrials.gov

A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa

Clinical trial2026-06-22Results expected Q4 2026 · ClinicalTrials.gov

Bimekizumab safety and efficacy in patients with psoriatic arthritis: 3-year results from two phase 3 studies.

Research2026-05-01Rheumatology (Oxford, England)

Bimekizumab efficacy in scalp, nail and palmoplantar psoriasis versus comparators and over 4 years.

Research2026-03-09The Journal of dermatological treatment

Bimekizumab efficacy using IHS4 outcomes in hidradenitis suppurativa: Results from BE HEARD I and II.

Research2026-02-14Journal of the European Academy of Dermatology and Venereology : JEADV

Bimekizumab efficacy and safety in Chinese patients with psoriasis in the BE SHINING Phase 3 study.

Research2026-02-12Journal of the European Academy of Dermatology and Venereology : JEADV

Approval: Bimzelx (EMA)

Regulatory2021-08-20EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Bimekizumab

Aliases & brands

Bimzelx

RxNorm CUI

2668041

UNII

09495UIM6V

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2021-08-20

Latest approval

2021-08-20

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2021-08-20Approval

Approval: Bimzelx (EMA)

Indication: Plaque psoriasis Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Bimzelx,… Show full indication

Plaque psoriasis Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Hidradenitis suppurativa (HS)Bimzelx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

49 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 49

Phase 16Phase 214Phase 324Phase 45

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Utilization of a Cutaneous Therapy In Situ Microdevice

Not yet recruitingPH IVUniversity of California, San Franciscon=102030

Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open?Label, Exploratory Trial

Not yet recruitingPH IVMayo Clinicn=122027

A Study to Evaluate the Safety and Efficacy of Bimekizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17 or IL-23 Therapies

CompletedPH IVIcahn School of Medicine at Mount Sinain=602026

Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study

CompletedPH IVRadboud University Medical Centern=2442025

Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis Who Have an Inadequate Skin Response to Anti-IL23 Therapy

WithdrawnPH IVInnovaderm Research Inc.2024

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multicenter, Randomized, Double-Blind, Risankizumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

CompletedPH IIIUCB Biopharma SRLn=6842026

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

CompletedPH IIIKey trialUCB Biopharma SRLn=1,1312026

A Study to Evaluate the Safety and Efficacy of Bimekizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17 or IL-23 Therapies

CompletedPH IVIcahn School of Medicine at Mount Sinain=602026

A Multicenter, Open-Label, Randomized Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis

CompletedPH IIUCB Biopharma SRLn=412025

CompletedPH IIIUCB Biopharma SRLn=1332025

Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study

CompletedPH IVRadboud University Medical Centern=2442025

Research activity

39 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20202026

Most influential

Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial.

JAMA dermatology · 2021 · 128 cites

Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study.

Annals of the rheumatic diseases · 2020 · 106 cites

Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials.

Annals of the rheumatic diseases · 2023 · 90 cites

Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study.

Journal of the American Academy of Dermatology · 2020 · 47 cites

Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study.

The British journal of dermatology · 2022 · 41 cites

Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study.

Annals of the rheumatic diseases · 2023 · 40 cites

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Guselkumab

Frequently co-studied with Bimekizumab in the research literature.

1 shared paper

Risankizumab

Frequently co-studied with Bimekizumab in the research literature.

1 shared paper

Secukinumab

Frequently co-studied with Bimekizumab in the research literature.

1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.