Bimzelx

(Bimekizumab)

ApprovedMonoclonal antibody

Bimekizumab is used to treat moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. It works by reducing inflammation in the body to help clear up these skin symptoms.[2] Bimzelx is currently approved and in use across 14 indications[4].[1]

Bimzelx is one of 251 monoclonal antibody programs targeting Psoriasis. It is currently in Approved.

Indications

Total Trials

Active Trials

250

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

PsoriasisCompleted

ArthritisCompleted

Immune System DiseaseUnknown

ParapsoriasisUnknown

Psoriasis VulgarisUnknown

Moderate-to-Severe Plaque PsoriasisActive, not recruiting

Rheumatic DiseaseRecruiting

Hidradenitis Suppurativa (HS)Not yet recruiting

Pyoderma GangrenosumNot yet recruiting

Pityriasis Rubra PilarisNot yet recruiting

PsoriasisApproved

Completed

ArthritisPhase 3

Completed

Immune System DiseasePreclinical

Unknown

ParapsoriasisPreclinical

Unknown

Psoriasis VulgarisPreclinical

Unknown

Moderate-to-Severe Plaque PsoriasisPhase 3

Active, not recruiting

Rheumatic DiseasePhase 2

Recruiting

Hidradenitis Suppurativa (HS)Phase 2

Not yet recruiting

Pyoderma GangrenosumPhase 2

Not yet recruiting

Pityriasis Rubra PilarisApproved

Not yet recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

127 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Bimzelx

UCB

Approved

1 2

Cytosar

Teva

Phase 3

1 3

Fludara

Sanofi

Phase 3

1 4

Adtralza

LEO Pharma

Phase 3

16 5

Amlitelimab

Sanofi

Phase 3

2 6

DUPIXENT

Regeneron

Phase 3

1 7

Certolizumab

Johnson & Johnson

Phase 3

1 8

Jaktinib

SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase 3

4 9

ICP-332

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

2 10

VC005

JJiangsu vcare pharmaceutical technology co., LTD

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Recruiting

Depressive Symptoms

NCT06786936

Q4 2027

ApprovedNot yet recruiting

Pityriasis Rubra Pilaris

NCT07497620

Phase 1Recruiting

Moderate-to-Severe Plaque Psoriasis

NCT06888193

Q1 2028

Phase 2Recruiting

Rheumatic Disease

NCT07138898

Phase 3Active, not recruiting

Moderate-to-Severe Plaque Psoriasis

NCT06506916

Q2 2028

Phase 2Not yet recruiting

Hidradenitis Suppurativa (HS)

NCT07766005

Clinical

Trials by Indication[1]

Psoriasis14 trials

Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 2·NCT02905006·250 enrolled

A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 2·NCT03025542·49 enrolled

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Completed·RRadboud University Medical Center·Phase 4·NCT04340076·244 enrolled

Show 11 more trials

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 3·NCT03598790·1,353 enrolled

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 2·NCT03010527·217 enrolled

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 2·NCT03230292·43 enrolled

A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO)

Completed· UCB logo

UCB·Phase 3·NCT03766685·172 enrolled

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 3·NCT03370133·567 enrolled

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis

Completed· UCB logo

UCB·Phase 3·NCT05020249·47 enrolled

Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?

Recruiting·—·Phase 2·NCT06742333·40 enrolled

A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 3·NCT03410992·435 enrolled

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 3·NCT03536884·743 enrolled

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 3·NCT03412747·478 enrolled

Bimekizumab in Plaque Psoriasis

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT06336343·60 enrolled

Psoriatic Arthritis9 trials

Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis

Withdrawn·IInnovaderm Research Inc.·Phase 4·NCT05499416

A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis

Completed· UCB logo

UCB·Phase 2·NCT03347110·184 enrolled

A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis

Completed· UCB logo

UCB·Phase 2·NCT02969525·206 enrolled

Show 6 more trials

Completed· UCB logo

UCB·Phase 3·NCT04109976·214 enrolled

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

Completed· UCB logo

UCB·Phase 3·NCT04009499·1,131 enrolled

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

Completed· UCB logo

UCB·Phase 3·NCT06624228·553 enrolled

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Completed· UCB logo

UCB·Phase 3·NCT03895203·852 enrolled

A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Completed· UCB logo

UCB·Phase 3·NCT03896581·400 enrolled

An Open-label, Randomized, Parallel-group, Noninferiority Study to Evaluate the Pharmacokinetics of Bimekizumab Administered Intravenously or as a Subcutaneous Injection in Participants With Active Psoriatic Arthritis and/or Active Axial Spondyloarthritis

Recruiting· UCB logo

UCB·Phase 1·NCT07290036·392 enrolled

Hidradenitis Suppurativa5 trials

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Completed· UCB logo

UCB·Phase 3·NCT04242498·509 enrolled

A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.

Completed· UCB logo

UCB·Phase 2·NCT03248531·90 enrolled

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Completed· UCB logo

UCB·Phase 3·NCT04242446·505 enrolled

Show 2 more trials

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

Active, not recruiting· UCB logo

UCB·Phase 3·NCT06921850·43 enrolled

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

Completed· UCB logo

UCB·Phase 3·NCT04901195·658 enrolled

Ankylosing Spondylitis4 trials

A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis

Completed· UCB logo

UCB·Phase 2·NCT02963506·303 enrolled

A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis

Completed· UCB logo

UCB·Phase 2·NCT03215277·76 enrolled

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

Completed· UCB logo

UCB·Phase 3·NCT03928743·332 enrolled

Show 1 more trial

A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

Completed· UCB logo

UCB·Phase 2·NCT03355573·255 enrolled

Moderate-to-severe Plaque Psoriasis4 trials

A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis

Active, not recruiting· UCB logo

UCB·Phase 3·NCT06425549·176 enrolled

A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

Recruiting· UCB logo

UCB·Phase 1·NCT06888193·20 enrolled

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

Completed· UCB logo

UCB·Phase 2·NCT04718896·41 enrolled

Show 1 more trial

A Phase 3b Exploratory Multicenter Open-Label Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis

Active, not recruiting· UCB logo

UCB·Phase 3·NCT06506916·89 enrolled

15 more indications

Arthritis2 trials

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

Completed· UCB logo

UCB·Phase 3·NCT03928704·274 enrolled

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

Recruiting· UCB logo

UCB·Phase 3·NCT06668181·40 enrolled

ART2 trials

A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants

Completed· UCB logo

UCB·Phase 1·NCT05292131·121 enrolled

A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants

Terminated· UCB logo

UCB·Phase 1·NCT04255862·71 enrolled

Depressive Symptoms1 trial

Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms

Recruiting·NNHS Greater Glasgow and Clyde··NCT06786936·50 enrolled

Influenza1 trial

A Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects

Completed· UCB logo

UCB·Phase 1·NCT03895385·56 enrolled

Atopic Dermatitis1 trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Rheumatoid Arthritis1 trial

Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 2·NCT02430909·159 enrolled

Adult1 trial

A Study to Compare the Blood Level of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-injector in Adult Healthy Volunteer Participants

Completed· UCB logo

UCB·Phase 1·NCT03707717·189 enrolled

Axial Spondyloarthritis1 trial

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

Completed· UCB logo

UCB·Phase 3·NCT04436640·508 enrolled

Pityriasis Rubra Pilaris1 trial

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

Not yet recruiting·MMayo Clinic·Approved·NCT07497620·12 enrolled

Palmoplantar Pustulosis1 trial

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

Recruiting· UCB logo

UCB·Phase 3·NCT07219420·320 enrolled

Pyoderma Gangrenosum1 trial

A Single-arm Open-label Study Assessing Efficacy of Bimekizumab in Adult Participants With Pyoderma Gangrenosum Over 24 Weeks

Not yet recruiting·OOregon Health and Science University·Phase 2·NCT07767864·15 enrolled

Hidradenitis Suppurativa (HS)1 trial

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-concept Trial to Assess the Efficacy and Safety of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa Receiving Standard of Care Treatment

Not yet recruiting·SSpyre Therapeutics, Inc.·Phase 2·NCT07766005·150 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Chronic Plaque Psoriasis1 trial

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

Completed· UCB logo

UCB·Phase 3·NCT06011733·133 enrolled

Unspecified1 trial

A Study to Evaluate the Relative Bioavailability and Tolerability of Bimekizumab in Healthy Subjects

Completed· UCB logo

UCB·Phase 1·NCT05028127·12 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 17, 2023

BIMZELX

NDA BLA761151

Oct 17, 2023

BIMZELX

BLA BLA761151

Sep 20, 2024

BIMZELX

NDA BLA761151

Sep 20, 2024

BIMZELX

NDA BLA761151

Sep 20, 2024

BIMZELX

NDA BLA761151

Oct 11, 2024

BIMZELX

NDA BLA761151

Nov 19, 2024

BIMZELX

NDA BLA761151

Sources

References

[1]
ClinicalTrials.gov — 53 trial records for Bimekizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Bimzelx drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bimekizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bimekizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761151). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Bimekizumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — UCB company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: IL-17A/IL-17F Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: UCB

Key Publications[6]

Bimekizumab in Moderate-to-Severe Psoriasis: BE SURE

N Engl J MedApr 7, 2022DOI: 10.1056/NEJMoa2205573

Bimzelx

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Psoriasis14 trials

Psoriatic Arthritis9 trials

Hidradenitis Suppurativa5 trials

Ankylosing Spondylitis4 trials

Moderate-to-severe Plaque Psoriasis4 trials

Arthritis2 trials

ART2 trials

Depressive Symptoms1 trial

Influenza1 trial

Atopic Dermatitis1 trial

Rheumatoid Arthritis1 trial

Adult1 trial

Axial Spondyloarthritis1 trial

Pityriasis Rubra Pilaris1 trial

Palmoplantar Pustulosis1 trial

Pyoderma Gangrenosum1 trial

Hidradenitis Suppurativa (HS)1 trial

Rheumatic Disease1 trial

Chronic Plaque Psoriasis1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News