Bimekizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Bimekizumab
- bimzelx
- Bimzelx
- bimekizumab
- Bimekizumab
- bimekizumab [INN]
- BIMEKIZUMAB [JAN]
- Bimekizumab [MI]
- BIMEKIZUMAB [USAN]
- Bimekizumab [WHO-DD]
- bimekizumab bkzx
- Bimekizumab bkzx [WHO-DD]
- bimekizumab bkzx who dd
- bimekizumab inn
- bimekizumab jan
- bimekizumab mi
- bimekizumab usan
- bimekizumab who dd
- Bimekizumab-bkzx
- immunoglobulin g1 kappa anti homo sapiens il17a interleukin 17a and homo sapiens il17f interleukin 17f humanized monoclonal antibody
- immunoglobulin g1 kappa anti homo sapiens il17a interleukin 17a and homo sapiens il17f interleukin 17f humanized monoclonal antibody gamma1 heavy chain 1 455 humanized vh homo sapiens ighv3 7 01 88 70 ighd ighj1 01 8 8 18 1 125 homo sapiens ighg1 01 ch1 126 223 hinge 224 238 ch2 239 348 ch3 349 453 chs 454 455 126 455 228 214 disulfide with kappa light chain 1 214 humanized v kappa homo sapiens igkv1 13 02 80 00 igkj1 01 6 3 9 1 107 homo sapiens igkc 01 108 214 dimer 234 234 237 237 bisdisulfide
- IMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS IL17A (INTERLEUKIN 17A) AND HOMO SAPIENS IL17F (INTERLEUKIN 17F)), HUMANIZED MONOCLONAL ANTIBODY
- IMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS IL17A (INTERLEUKIN 17A) AND HOMO SAPIENS IL17F (INTERLEUKIN 17F)), HUMANIZED MONOCLONAL ANTIBODY GAMMA1 HEAVY CHAIN (1-455) (HUMANIZED VH (HOMO SAPIENS IGHV3-7*01 (88.70%) -(IGHD)-IGHJ1*01) (8.8.18) (1-125)-HOMO SAPIENS IGHG1*01 (CH1 (126-223), HINGE (224-238), CH2 (239- 348), CH3 (349-453), CHS (454-455)) (126-455)), (228-214')- DISULFIDE WITH KAPPA LIGHT CHAIN (1'-214') (HUMANIZED V-KAPPA (HOMO SAPIENS IGKV1-13*02 (80.00%) -IGKJ1*01) (6.3.9) (1'-107') - HOMO SAPIENS IGKC*01 (108'-214')) DIMER (234-234'':237-237'')- BISDISULFIDE
- ucb 4940
- UCB-4940
- ucb4940
- Ucb4940
- UCB4940
And 6 more, listed on the interactive page.
- CAS registry numbers
- 1418205-77-2
- ChEMBL ID
- CHEMBL4297700
- FDA ingredient codes (UNII)
- 09495UIM6V
- L04AC
- L04AC21
Sources for recorded values
- 2668041
- 2668080
- Applicant
- UCB INC
- Approval date
- 17 Oct 2023
- Application number
- BLA761151
- Status
- Authorised
- Status date
- 20 Aug 2021
- Authorisation date
- 20 Aug 2021
- Approved indications
- 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.
- Product number
- EMEA/H/C/005316
- Authorisation holder
- UCB Pharma S.A.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Psoriasis
European medicines record
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Pharmacology name
- bimekizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- IL-17A
- Gene symbol
- IL-17A
- Median affinity
- 10.68
- Affinity units
- pKd
- Primary target
- Yes
- Action
- Binding
- Action type
- Binding
- Target
- IL-17F
- Gene symbol
- IL-17F
- Primary target
- Yes
- Mechanism
- Interleukin 17A inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-17A
- Protein identifier
- Q16552
- Mechanism
- Interleukin-17F inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-17F
- Protein identifier
- Q96PD4
- Mechanism
- Interleukin 17A inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-17A
- Mechanism
- Interleukin-17F inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-17F
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Psoriasis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000676
- Subject identifier
- D011565
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Arthritis, Psoriatic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003778
- Subject identifier
- D015535
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Hidradenitis Suppurativa
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000710
- Subject identifier
- D017497
- Condition
- Parapsoriasis
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000747
- Subject identifier
- D010267
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000676
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003778
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003898
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000710
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000747
- Condition identifier
- EFO_1001494
- Condition identifier
- EFO_1001494
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0002050
- Condition identifier
- MONDO_0005046
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005083
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005306
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0006559
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0006592
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0008383
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0011429
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0011849
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0015597
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0019436
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0019437
- Highest recorded phase
- 3
- Event
- abdominal pain
- Reports
- 2
- Reporting signal score
- 26.425
- Event
- acne
- Reports
- 41
- Reporting signal score
- 64.2457
- Event
- anaemia
- Reports
- 2
- Reporting signal score
- 27.0904
- Event
- asthenia
- Reports
- 5
- Reporting signal score
- 29.5437
- Event
- axial spondyloarthritis
- Reports
- 4
- Reporting signal score
- 14.1377
- Event
- blood pressure increased
- Reports
- 1
- Reporting signal score
- 11.824
- Event
- candida infection
- Reports
- 47
- Reporting signal score
- 105.904
- Event
- cerebrovascular accident
- Reports
- 1
- Reporting signal score
- 16.2781
- Event
- condition aggravated
- Reports
- 328
- Reporting signal score
- 440.823
- Event
- constipation
- Reports
- 2
- Reporting signal score
- 17.7592
- Event
- dehydration
- Reports
- 1
- Reporting signal score
- 15.8354
- Event
- device defective
- Reports
- 15
- Reporting signal score
- 32.9059
- Event
- dizziness
- Reports
- 7
- Reporting signal score
- 39.093
- Event
- drug hypersensitivity
- Reports
- 12
- Reporting signal score
- 13.11
- Event
- dyspnoea
- Reports
- 5
- Reporting signal score
- 54.2535
- Event
- ear infection
- Reports
- 17
- Reporting signal score
- 15.4787
- Event
- fall
- Reports
- 3
- Reporting signal score
- 32.9385
- Event
- fungal infection
- Reports
- 37
- Reporting signal score
- 50.0073
- Event
- furuncle
- Reports
- 10
- Reporting signal score
- 14.4267
- Event
- gait disturbance
- Reports
- 2
- Reporting signal score
- 12.5896
- Event
- haemoglobin decreased
- Reports
- 1
- Reporting signal score
- 14.846
- Event
- hidradenitis
- Reports
- 355
- Reporting signal score
- 1,961.03
- Event
- hyperhidrosis
- Reports
- 1
- Reporting signal score
- 12.2275
- Event
- hypertension
- Reports
- 2
- Reporting signal score
- 22.1185
- Event
- illness
- Reports
- 29
- Reporting signal score
- 42.5379
And 26 more, listed on the interactive page.
- NCT02141763
- NCT02969525
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And 8 more, listed on the interactive page.
- Dose
- 320mg
- Route
- Subcutaneous
- How often
- Weeks 0, 4, 8, 12, 16, then every 8 weeks thereafter; consider every 4 weeks after Week 16 for patients ≥120kg
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYNMAWVRQAPGKGLEWVATITYEGRNTYYRDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCASPPQYYEGSIYRLWFAHWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- AIQLTQSPSSLSASVGDRVTITCRADESVRTLMHWYQQKPGKAPKLLIYLVSNSEIGVPDRFSGSGSGTDFRLTISSLQPEDFATYYCQQTWSDPWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Glycosylation sites (N)
- Sequence
- Asn305 $ Asn305''''
- Component
- Glycosylation sites (N)
- Sequence
- Asn305 $ Asn305''
- Component
- Disulfide bridges
- Sequence
- 22-96 $ 22''-96'' $ 23'-88' $ 23'''-88''' $ 134'-194' $ 134'''-194''' $ 152-208 $ 152''-208'' $ 214'-228 $ 214'''-228'' $ 234-234'' $ 237-237'' $ 269-329 $ 269''-329'' $ 375-433 $ 375''-433''
- 50474-780
- 50474-781
- 50474-782
- 50474-783
Related records
Trials (55)
- A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants
- A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)
- A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
- A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
- A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
- A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
- A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of UCB4940 in Patients With Psoriasis
- 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
- A Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects
- A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants
- 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
- A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
- 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
- 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
- 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
- A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis
- A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
- A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
- A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
- A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis
Approved for (3)
- Immune system disorder
- Parapsoriasis
- Psoriasis
In development for (5)
- Ankylosing spondylitis Phase 3
- Hidradenitis suppurativa Phase 3
- Palmoplantar pustulosis Phase 3
- Psoriatic arthritis Phase 3
- Rheumatoid arthritis Phase 2