Secukinumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2015
- First approval year
- 2015
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Secukinumab
- cosentyx
- Cosentyx
- ain 457
- AIN 457
- AIN-457
- ain457
- AIN457
- AIN457 (secukinumab)
- AIN457 150 mg
- AIN457 150mg
- AIN457 300 mg
- AIN457 300mg
- ain457a
- AIN457A
- cosentyx
- Cosentyx
- Cosentyx (EU-licensed)
- Cosentyx (US-licensed)
- immunoglobulin g1 kappa anti homo sapiens il17a interleukin 17a il 17a homo sapiens monoclonal antibody
- IMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS IL17A (INTERLEUKIN 17A, IL-17A)), HOMO SAPIENS MONOCLONAL ANTIBODY
- secukinumab
- Secukinumab
- Secukinumab (150 mg)
- Secukinumab (75 mg)
- secukinumab (AIN457)
- Secukinumab (AIN457)
- Secukinumab (AIN457) 150 mg s.c.
And 25 more, listed on the interactive page.
- ATC classification codes
- L04AC10
Sources for recorded values
- CAS registry numbers
- 1229022-83-6
- ChEMBL ID
- CHEMBL1743068
- RxNorm IDs (RxCUI)
- 1599788
- FDA ingredient codes (UNII)
- DLG4EML025
- Applicant
- NOVARTIS PHARMS CORP
- Approval date
- 21 Jan 2015
- Application number
- BLA125504
- Status
- Authorised
- Status date
- 14 Jan 2015
- Authorisation date
- 14 Jan 2015
- Approved indications
- Plaque psoriasis Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. Hidradenitis suppurativa (HS) Cosentyx 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. Psoriatic arthritis Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. Axial spondyloarthritis (axSpA) Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-axSpA) Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs). Juvenile idiopathic arthritis (JIA) Enthesitis-related arthritis (ERA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Juvenile psoriatic arthritis (JPsA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
- Product number
- EMEA/H/C/003729
- Authorisation holder
- Novartis Europharm 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, Psoriatic
- Psoriasis
- Spondylitis, Ankylosing
European medicines record
- Patents
- 0
- Designations
- 1
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- secukinumab
- Type
- Antibody
- Drug name stem
- -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
- 9.91
- 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
- Dermatitis, Atopic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000274
- Subject identifier
- D003876
- Condition
- Crohn Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- 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
- 3
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Spondylarthropathies
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000706
- Subject identifier
- D025242
- Condition
- Inflammatory Bowel Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003767
- Subject identifier
- D015212
- Condition
- Arthritis, Psoriatic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003778
- Subject identifier
- D015535
- Condition
- Behcet Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003780
- Subject identifier
- D001528
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Multiple Sclerosis, Relapsing-Remitting
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003929
- Subject identifier
- D020529
- Condition
- Alopecia Areata
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004192
- Subject identifier
- D000506
- Condition
- Lupus Nephritis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005761
- Subject identifier
- D008181
- Condition
- Polymyalgia Rheumatica
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008518
- Subject identifier
- D011111
- Condition
- Lichen Planus
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009856
- Subject identifier
- D008010
- Condition
- Hidradenitis Suppurativa
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000710
- Subject identifier
- D017497
- Condition
- Necrobiosis Lipoidica
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000738
- Subject identifier
- D009335
- Condition
- Rosacea
- Highest recorded phase
- 1
- Condition identifier
- EFO:1000760
- Subject identifier
- D012393
- Condition
- Dry Eye Syndromes
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000906
- Subject identifier
- D015352
- Condition
- Giant Cell Arteritis
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001209
- Subject identifier
- D013700
- Condition
- Uveitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001231
- Subject identifier
- D014605
- Condition
- Tendinopathy
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001434
- Subject identifier
- D052256
- Condition
- Graves Ophthalmopathy
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001466
- Subject identifier
- D049970
- 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
And 7 more, listed on the interactive page.
- Condition identifier
- EFO_0000274
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000384
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000676
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000706
- Condition identifier
- EFO_0002617
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003767
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003778
- Condition identifier
- EFO_0003780
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003898
- Condition identifier
- EFO_0003929
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004192
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005761
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008518
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009733
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009856
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000710
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000738
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000760
- Condition identifier
- EFO_1000906
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001209
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001231
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001434
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001466
- Highest recorded phase
- 3
And 48 more, listed on the interactive page.
- Event
- ankylosing spondylitis
- Reports
- 447
- Reporting signal score
- 1,079.31
- Event
- arthralgia
- Reports
- 2,101
- Reporting signal score
- 1,131.67
- Event
- arthritis
- Reports
- 599
- Reporting signal score
- 540.115
- Event
- joint swelling
- Reports
- 734
- Reporting signal score
- 441.896
- Event
- malaise
- Reports
- 1,487
- Reporting signal score
- 400.597
- Event
- musculoskeletal stiffness
- Reports
- 765
- Reporting signal score
- 632.915
- Event
- nasopharyngitis
- Reports
- 997
- Reporting signal score
- 633.58
- Event
- pain
- Reports
- 2,393
- Reporting signal score
- 1,137.64
- Event
- pain in extremity
- Reports
- 1,171
- Reporting signal score
- 419.363
- Event
- product dose omission issue
- Reports
- 589
- Reporting signal score
- 494.976
- Event
- pruritus
- Reports
- 1,411
- Reporting signal score
- 617.334
- Event
- psoriasis
- Reports
- 3,770
- Reporting signal score
- 6,813.03
- Event
- psoriatic arthropathy
- Reports
- 1,516
- Reporting signal score
- 3,311.57
- Event
- sinusitis
- Reports
- 632
- Reporting signal score
- 379.695
- Event
- skin exfoliation
- Reports
- 430
- Reporting signal score
- 417.529
- Event
- skin plaque
- Reports
- 304
- Reporting signal score
- 592.141
- Event
- therapeutic product effect incomplete
- Reports
- 675
- Reporting signal score
- 886.114
- NCT00584740
- NCT01009281
- NCT00669916
- NCT00770965
- NCT00805480
- NCT00941031
- NCT01071252
- NCT01132612
- NCT01358578
- NCT01365455
- NCT01406938
- NCT01412944
- NCT01537432
- NCT01539213
- NCT01544595
- NCT01555125
- NCT01636687
- NCT01640951
- NCT01806597
- NCT01807520
- NCT01828086
- NCT01952015
- NCT01961609
- NCT02008890
- NCT02074982
And 136 more, listed on the interactive page.
- Dose
- 150 mg or 300 mg
- Route
- Subcutaneous
- How often
- Weeks 0, 1, 2, 3, 4 then every 4 weeks afterward
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Light chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLIYGASSRATGIPDRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSSPCTFGQGTRLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Heavy chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFTFSNYWMNWVRQAPGKGLEWVAAINQDGSEKYYVGSVKGRFTISRDNAKNSLYLQMNSLRVEDTAVYYCVRDYYDILTDYYIHYWYFDLWGRGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- 0078-0639
- 0078-1056
- 0078-1070
- 0078-1168
Related records
Trials (317)
- "Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"
- 16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis
- 16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
- 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
- 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
- 16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients
- 24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
- 38 Week Extension Study to CAIN457C2303
- 3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain
- 4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
- A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)
- A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
- A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
- A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants
- A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients
- A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.
- A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers
- A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
- A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With Breast Cancer Gene (BRCA) Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer
- A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Approved for (6)
- Ankylosing spondylitis
- Immune system disorder
- Palmoplantar pustulosis
- Psoriasis
- Psoriatic arthritis
- Spondyloarthropathy
In development for (29)
- Alopecia Phase 2
- Alopecia areata Phase 2
- Asthma Phase 2
- Atopic eczema Phase 2
- Behcet disease Phase 3
- COVID-19 Phase 2
- Crohn disease Phase 2
- Discoid lupus erythematosus Phase 2
- Disease of the tendon Phase 3
- Dry eye syndrome Phase 2
- Euthyroid Graves orbitopathy Phase 3
- Hidradenitis suppurativa Phase 3
- Inflammatory bowel disease Phase 2
- Lichen planus Phase 2
- Lupus nephritis Phase 3
- Metastatic melanoma Phase 1
- Multiple sclerosis Phase 2
- Necrobiosis lipoidica Phase 2
- Osteoarthritis Phase 3
- Pityriasis rubra pilaris Phase 1
Other linked conditions (1)
- Generalized pustular psoriasis
Targets (1)
- IL17A Interleukin 17A inhibitor