Ixekizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2016
- First approval year
- 2016
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Ixekizumab
- taltz
- Taltz
- 80 mg ixekizumab
- ixekizumab
- Ixekizumab
- ixekizumab [INN]
- IXEKIZUMAB [JAN]
- IXEKIZUMAB [MI]
- IXEKIZUMAB [PURPLE BOOK CDER]
- IXEKIZUMAB [USAN]
- Ixekizumab [WHO-DD]
- ixekizumab inn
- ixekizumab jan
- ixekizumab mi
- ixekizumab purple book cder
- ixekizumab usan
- ixekizumab who dd
- ly 2439821
- LY-2439821
- ly2439821
- LY2439821
- Taltz
- ATC classification codes
- L04AC13
Sources for recorded values
- CAS registry numbers
- 1143503-69-8
- ChEMBL ID
- CHEMBL1743034
- RxNorm IDs (RxCUI)
- 1745099
- FDA ingredient codes (UNII)
- BTY153760O
- Applicant
- ELI LILLY AND CO
- Approval date
- 22 Mar 2016
- Application number
- BLA125521
- Status
- Authorised
- Status date
- 25 Apr 2016
- Authorisation date
- 25 Apr 2016
- Approved indications
- Plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Paediatric plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy.Psoriatic arthritisTaltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies. Axial spondyloarthritis Ankylosing spondylitis (radiographic axial spondyloarthritis)Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis Taltz is indicated for the treatment of adult patients 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 to nonsteroidal anti-inflammatory drugs (NSAIDs).Juvenile idiopathic arthritis (JIA)Juvenile psoriatic arthritis (JPsA)Taltz, alone or in combination with methotrexate, is indicated for the treatment of active JPsA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.Enthesitis-related arthritis (ERA)Taltz, alone or in combination with methotrexate, is indicated for the treatment of active ERA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.
- Product number
- EMEA/H/C/003943
- Authorisation holder
- Eli Lilly and Company (Ireland) Limited
- 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
- Arthritis, Juvenile
- Arthritis, Psoriatic
- Axial Spondyloarthritis
- Psoriasis
European medicines record
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Pharmacology name
- ixekizumab
- 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
- 11.7
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Interleukin 17A inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-17A
- Protein identifier
- Q16552
Open Targets mechanisms
- Mechanism
- Interleukin 17A inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-17A
- 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
- 4
- Condition identifier
- EFO:0003778
- Subject identifier
- D015535
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Constriction, Pathologic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0006818
- Subject identifier
- D003251
- Condition
- Pemphigoid, Bullous
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007187
- Subject identifier
- D010391
- Condition
- Lichen Planus
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0009856
- Subject identifier
- D008010
- Condition
- Lichen Planus
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:1000726
- Subject identifier
- D008010
- Condition
- Psoriasis
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001494
- Subject identifier
- D011565
- Condition
- Pyoderma
- Highest recorded phase
- 2
- Condition identifier
- HP:0000999
- Subject identifier
- D011711
- Condition
- Depressive Disorder, Major
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002009
- Subject identifier
- D003865
- Condition
- Diabetes Mellitus, Type 1
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005147
- Subject identifier
- D003922
- Condition
- Guttate Psoriasis
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0023297
- Subject identifier
- D000098650
- Condition
- Pityriasis Rubra Pilaris
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0100017
- Subject identifier
- D010916
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000676
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003778
- Condition identifier
- EFO_0003898
- Highest recorded phase
- 3
- Condition identifier
- EFO_0006818
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007187
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009856
- Condition identifier
- EFO_0009856
- Highest recorded phase
- 1
- Condition identifier
- EFO_1000726
- Condition identifier
- EFO_1001494
- Condition identifier
- EFO_1001494
- Highest recorded phase
- 4
- Condition identifier
- HP_0000999
- Highest recorded phase
- 2
- Condition identifier
- HP_0001513
- Highest recorded phase
- 3
- Condition identifier
- HP_0025502
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002009
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002050
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005046
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005083
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005147
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005306
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0006572
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0008383
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0011849
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0019082
- Highest recorded phase
- 2
And 9 more, listed on the interactive page.
- Event
- covid-19
- Reports
- 128
- Reporting signal score
- 102.993
- Event
- dizziness
- Reports
- 52
- Reporting signal score
- 85.2518
- Event
- drug interaction
- Reports
- 3
- Reporting signal score
- 94.6541
- Event
- dyspnoea
- Reports
- 67
- Reporting signal score
- 93.5412
- Event
- ear infection
- Reports
- 94
- Reporting signal score
- 124.375
- Event
- hypotension
- Reports
- 7
- Reporting signal score
- 91.8414
- Event
- injection site erythema
- Reports
- 435
- Reporting signal score
- 459.82
- Event
- injection site pain
- Reports
- 492
- Reporting signal score
- 379.577
- Event
- injection site pruritus
- Reports
- 150
- Reporting signal score
- 104.796
- Event
- injection site rash
- Reports
- 101
- Reporting signal score
- 111.624
- Event
- injection site reaction
- Reports
- 419
- Reporting signal score
- 610.309
- Event
- injection site swelling
- Reports
- 315
- Reporting signal score
- 396.432
- Event
- injection site urticaria
- Reports
- 87
- Reporting signal score
- 109.124
- Event
- psoriasis
- Reports
- 416
- Reporting signal score
- 419.956
- Event
- sinusitis
- Reports
- 166
- Reporting signal score
- 101.493
- Event
- therapy interrupted
- Reports
- 179
- Reporting signal score
- 338.748
- NCT00966875
- NCT01236118
- NCT01253265
- NCT01107457
- NCT01474512
- NCT01597245
- NCT01624233
- NCT01646177
- NCT01777191
- NCT02387801
- NCT02513550
- NCT02561806
- NCT02634801
- NCT02718898
- NCT02993471
- NCT03073200
- NCT03073213
- NCT03364309
- NCT03573323
- NCT04340076
- NCT04537689
- NCT01695239
- NCT02349295
- NCT02584855
- NCT03151551
And 17 more, listed on the interactive page.
- Dose
- 80 mg
- Route
- Subcutaneous
- How often
- Every 4 weeks
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGSSVKVSCKASGYSFTDYHIHWVRQAPGQGLEWMGVINPMYGTTDYNQRFKGRVTITADESTSTAYMELSSLRSEDTAVYYCARYDYFTGTGVYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLG
- Component
- Light chain
- Type
- Protein
- Sequence
- DIVMTQTPLSLSVTPGQPASISCRSSRSLVHSRGNTYLHWYLQKPGQSPQLLIYKVSNRFIGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCSQSTHLPFTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 0002-1445
- 0002-7724
- 0002-8900
- 0002-8905
Related records
Trials (61)
- A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
- A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
- A Phase 3 Study in Participants With Moderate to Severe Psoriasis
- A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)
- A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
- A Study in Japanese Participants With Moderate-to-Severe Psoriasis
- A Study in Participants With Moderate to Severe Psoriasis
- A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)
- A Study in Patients With Rheumatoid Arthritis
- A Study in Rheumatoid Arthritis
- A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
- A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis
- A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
- A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
- A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis
- A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India
- A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
- A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
- A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
- A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis
Approved for (4)
- Immune system disorder
- Palmoplantar pustulosis
- Psoriasis
- Psoriatic arthritis
In development for (10)
- Ankylosing spondylitis Phase 3
- Bullous pemphigoid Phase 2
- COVID-19 Phase 3
- Guttate psoriasis Phase 2
- Lichen planus Early phase 1
- Major depressive disorder Phase 2
- Pityriasis rubra pilaris Phase 2
- Pyoderma Phase 2
- Rheumatoid arthritis Phase 2
- Type 1 diabetes mellitus Phase 2
Other linked conditions (1)
- Pustular psoriasis
Targets (1)
- IL17A Interleukin 17A inhibitor