Bimekizumab

Bimekizumab-bkzx is a humanized immunoglobulin IgG1/ κ monoclonal antibody with two identical antigen binding regions that selectively bind to human interleukin 17A (IL-17A), interleukin 17F (IL-17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17 receptor complex. IL-17A and IL-17F are naturally occurring cytokines that are involved in normal inflammatory and immune responses.

• BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Adults with active psoriatic arthritis (PsA) .ICD-10: L40.50, L40.9

• None. None.contraindicated

Prior to treatment: ( 2.1 ) Evaluate patients for tuberculosis infection. Test liver enzymes, alkaline phosphatase, and bilirubin. Complete all age-appropriate vaccinations as recommended by current immunization guidelines. Plaque Psoriasis Administer 320 mg by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg or more, consider a dose of 320 mg every 4 weeks after Week 16. ( 2.2 ) Psoriatic Arthritis Administer 160 mg by subcutaneous injection every 4 weeks. ( 2.3 ) For patients with coexisting moderate to severe plaque psoriasis, use the dosage and administration for plaque psoriasis. ( 2.2 ) Non-Radiographic Axial Spondyloarthritis Administer 160 mg by subcutaneous injection every 4 weeks. ( 2.4 ) Ankylosing Spondylitis Administer 160 mg by subcutaneous injection every 4 weeks. ( 2.5 ) Hidradenitis Suppurativa Administer 320 mg by subcutaneous injection at Week 0, 2, 4, 6, 8, 10, 12, 14 and 16, then every 4 weeks thereafter. ( 2.6 ) See full prescribing information for recommendations regarding missed doses, preparation and administration instructions. ( 2.7 , 2.8 , 2.9 ) 2.1 Recommended Evaluations and Immunization Prior to Treatment Initiation Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX [see Warnings and Precautions (5.3) ] . Test liver enzymes, alkaline phosphatase and bilirubin prior to initiating treatment with BIMZELX [see Warnings and Precautions (5.4) ] .

Suicidal Ideation and Behavior (SI/B) : May increase risk of SI/B. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988. Carefully weigh risks and benefits of treatment with BIMZELX in patients with a history of severe depression and/or suicidal ideation or behavior. ( 5.1 ) Infections : May increase risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer BIMZELX until the infection resolves. ( 5.2 ) Tuberculosis (TB) : Avoid use in patients with active TB. Initiate treatment of latent TB prior to BIMZELX treatment. ( 5.3 ) Liver Biochemical Abnormalities : Elevated serum transaminases were reported in clinical trials. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and according to routine patient management. Permanently discontinue use of BIMZELX in patients with causally - associated combined elevations of transaminases and bilirubin. ( 5.4 ) Inflammatory Bowel Disease (IBD) : Cases of IBD were reported in clinical trials with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. Monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

The following adverse reactions have been observed with BIMZELX and are discussed in greater detail in other sections of the labeling: Suicidal Ideation and Behavior [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Liver Biochemical Abnormalities [see Warnings and Precautions (5.4) ] Inflammatory Bowel Disease [see Warnings and Precautions (5.5) ] Most common adverse reactions are: Psoriasis and Hidradenitis Suppurativa (incidence ≥ 1%): upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. ( 6.1 ) Psoriatic Arthritis (incidence ≥ 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection. ( 6.1 ) Non-Radiographic Axial Spondyloarthritis (incidence ≥ 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsilitis, transaminase increase, and urinary tract infection. ( 6.1 ) Ankylosing Spondylitis (incidence ≥ 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash and vulvovaginal mycotic infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to BIMZELX during pregnancy. For more information, healthcare providers or patients can contact the Organization of Teratology Information Specialists (OTIS) AutoImmune Diseases Study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/. Risk Summary Available data from case reports on BIMZELX use in pregnant women are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, BIMZELX may be transmitted from the mother to the developing fetus (see Clinical Considerations ) . In an enhanced pre- and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of bimekizumab-bkzx during the period of organogenesis through parturition at doses up to 38 times the maximum recommended human dose (MRHD) (see Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.

Metabolism

Bimekizumab-bkzx pharmacokinetics are comparable in adult patients with moderate to severe plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. The median peak plasma concentration of bimekizumab-bkzx was 25 (range: 12-50) μg/mL and was reached in 3-4 days.

• Oct 17, 2023BLABLA761151Ucb Inc

1. 1Product Dose Omission Issue2,60416%
2. 2Psoriasis2,01913%
3. 3Drug Ineffective1,4879.3%
4. 4Psoriatic Arthropathy1,3918.7%
5. 5Off Label Use1,2027.5%
6. 6Hidradenitis1,1917.4%
7. 7Injection Site Pain9606.0%
8. 8Condition Aggravated9115.7%
9. 9Inappropriate Schedule Of Product Administration7664.8%
10. 10Therapy Interrupted7354.6%
11. 11Product Availability Issue7044.4%
12. 12Incorrect Dose Administered5713.6%
13. 13Pain5683.5%
14. 14Oral Candidiasis5593.5%
15. 15Fatigue5323.3%

The 10 most recently updated of 59 ClinicalTrials.gov registrations naming Bimekizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
  Recruiting · Phase 3 · Interventional · 320 enrolled · UCB Biopharma SRL
  NCT07219420updated 2026-06-05
• A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
  Active not recruiting · Phase 3 · Interventional · 658 enrolled · UCB Biopharma SRL
  NCT04901195updated 2026-06-05
• A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
  Active not recruiting · Phase 3 · Interventional · 684 enrolled · UCB Biopharma SRL
  NCT06624228updated 2026-06-05
• An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
  Recruiting · Phase 3 · Interventional · 40 enrolled · UCB Biopharma SRL
  NCT06668181updated 2026-06-05
• A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
  Recruiting · Phase 1 · Interventional · 392 enrolled · UCB Biopharma SRL
  NCT07290036updated 2026-06-05
• A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
  Recruiting · Phase 3 · Interventional · 40 enrolled · UCB Biopharma SRL
  NCT06921850updated 2026-06-05
• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 10 enrolled · University of California, San Francisco
  NCT07352566updated 2026-06-03
• A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
  Completed · Phase 3 · Interventional · 1,131 enrolled · UCB Biopharma SRL
  NCT04009499updated 2026-06-01
• A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis
  Active not recruiting · Phase 3 · Interventional · 508 enrolled · UCB Biopharma SRL
  NCT04436640updated 2026-05-22
• A 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
  Recruiting · Phase 3 · Interventional · 168 enrolled · UCB Biopharma SRL
  NCT06425549updated 2026-05-22

Frequently asked questions

How does Bimekizumab work?

Bimekizumab-bkzx is a humanized immunoglobulin IgG1/ κ monoclonal antibody with two identical antigen binding regions that selectively bind to human interleukin 17A (IL-17A), interleukin 17F (IL-17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17 receptor complex. IL-17A and IL-17F are naturally occurring cytokines that are involved in normal inflammatory and immune responses.

What is Bimekizumab used for?

According to FDA labeling, Bimekizumab carries indications including: BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Adults with active psoriatic arthritis (PsA) .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Bimekizumab?

Bimekizumab is classified as Interleukin inhibitors, Interleukin-17A-directed Antibody Interactions, Decreased Cytokine Activity.

What are the brand names for Bimekizumab?

Bimekizumab is marketed under brand names including Bimzelx.

What are the contraindications for Bimekizumab?

Bimekizumab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.