COSENTYX (secukinumab)
COSENTYX is indicated for the treatment of Moderate to severe plaque psoriasis in patients 6 years and older; Active psoriatic arthritis in patients 2 years and older; Active ankylosing spondylitis in adults; Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults; Active enthesitis-related arthritis in pediatric patients 4 years and older; Moderate to severe hidradenitis suppurativa in adults.
How COSENTYX Works
Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine. By binding to IL-17A, the drug inhibits the cytokine's ability to interact with the IL-17 receptor. This blockade prevents the subsequent release of proinflammatory cytokines and chemokines that contribute to inflammatory and immune responses.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-01-21
- Patent Cliff
- 2029
- Revenue
- $1.8B (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
COSENTYX Approval History
What COSENTYX Treats
6 indicationsCOSENTYX is approved for 6 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Moderate to severe plaque psoriasis in patients 6 years and older
- Active psoriatic arthritis in patients 2 years and older
- Active ankylosing spondylitis in adults
- Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults
- Active enthesitis-related arthritis in pediatric patients 4 years and older
- Moderate to severe hidradenitis suppurativa in adults
COSENTYX Target & Pathway
ProTarget
A pro-inflammatory cytokine produced by Th17 cells that plays a key role in psoriasis, psoriatic arthritis, and ankylosing spondylitis. Blocking IL-17 reduces the inflammatory cascade that causes skin plaques and joint inflammation.
COSENTYX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in COSENTYX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications COSENTYX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to COSENTYX
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
87 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06398652 | CMAB015-002 | Ph 3 | completed | Comparative Study of CMAB015 and Secukinumab for Patients With Moderate to Severe Plaque Psoriasis |
| NCT03440736 METABOLYX results posted | CAIN457ADE08 2016-001671-79 | Ph 4 | completed | Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome |
| NCT07489573 | CAIN457M2401 | Ph 4 | not yet recruiting | Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa |
| NCT06331312 REPLENISH-EXT | CAIN457C22301E1 2023-508077-85-00 | Ph 3 | active not recruiting | Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR) |
| NCT03536884 BE RADIANT results posted | PS0015 2017-003784-35 | Ph 3 | completed | 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 |
| NCT04737330 ORBIT results posted | CAIN457ADE16 2020-001611-24 | Ph 3 | terminated | A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED) |
| NCT04732117 results posted | CAIN457I2301 | Ph 3 | completed | Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis |
| NCT06130540 | CAIN457E22101 2023-507667-19-00 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR |
| NCT07477795 STARS | APHP240614 | Ph 2 | not yet recruiting | Phase II Interventional Study Evaluating Efficacy and Safety of Secukinumab in Active Severe Takayasu Patients |
| NCT06945107 | CIBI112A303CN | Ph 3 | active not recruiting | A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy |
| NCT05722522 results posted | CAIN457O12301 2022-502068-19-00 | Ph 3 | terminated | Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy |
| NCT04340076 BeNeBio | 80-85200-98-18562 2019-004230-42 | Ph 4 | completed | Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis |
| NCT06751238 | CAIN457G22101 | Ph 1 | recruiting | Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA). |
| NCT05622708 | CAIN457I2401 2022-001153-23, 2023-509320-17-00 | Ph 4 | active not recruiting | A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission |
| NCT04179175 results posted | CAIN457M2301E1 2023-508956-20 | Ph 3 | active not recruiting | Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa |
| NCT05569174 UnchAIN results posted | CAIN457FDE05 2022-001516-26 | Ph 3 | completed | Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT05758415 results posted | CAIN457O12302 2022-502080-38-00 | Ph 3 | terminated | Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy |
| NCT03651518 PIMOC | P160906J 2017-000519-18 | Ph 2 | completed | Personalized Therapies in Inflammatory Complex Disease |
| NCT03769168 results posted | CAIN457F2304E1 2018-002521-30 | Ph 3 | completed | An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) |
| NCT04632927 AgAIN results posted | CAIN457FDE04 2019-004246-15 | Ph 3 | completed | Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT04717466 results posted | 20200857 | Ph 4 | completed | Brain Changes in Psoriasis After Secukinumab Treatment |
| NCT04181762 SELUNE results posted | CAIN457Q12301 2019-003211-57, PACTR202211748997845 | Ph 3 | terminated | Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis |
| NCT05232864 results posted | CAIN457Q12301E1 2021-005772-19 | Ph 3 | terminated | Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis |
| NCT05080218 COVER | COVER-Main | Ph 4 | completed | COVID-19 VaccinE Response in Rheumatology Patients |
| NCT06833112 | 2024114K | Ph 4 | not yet recruiting | Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis |
| NCT04589026 PLATFORM | CR108908 2020-002480-59, NOPRODPANAP1001 | Ph 1 | completed | A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 1 |
| NCT05522517 | CR109261 2022-001636-29, NOPRODPANAP1004 | Ph 1 | completed | A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 4 |
| NCT03020199 STEPin results posted | CAIN457A2322 2015-002423-26 | Ph 4 | completed | Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis |
| NCT03445845 ROC-SPA | 1608185 2017-004700-22 | Ph 4 | completed | Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis |
| NCT03713619 SUNSHINE results posted | CAIN457M2301 2018-002063-26 | Ph 3 | completed | This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS). |
| NCT03713632 SUNRISE results posted | CAIN457M2302 2018-002062-39 | Ph 3 | completed | Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) |
| NCT04156620 results posted | CAIN457P12301 | Ph 3 | completed | Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA |
| NCT03791060 results posted | 2018P000634 | Ph 2 | terminated | Secukinumab for NLD (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD) |
| NCT05734482 | CMAB015-001 | Ph 1 | completed | Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers |
| NCT03623867 | PsA secukinumab XCT study 2018 | Ph 4 | completed | PsA Secukinumab XCT Structural Progression Study |
| NCT02733094 | CAIN547ADE01T | Ph 1, Ph 2 | completed | Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum |
| NCT03055494 ObePso-S results posted | CAIN457AUS07 | Ph 4 | completed | Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients |
| NCT05676333 | 2016/0237 | Ph 4 | completed | Secukinumab in Active Non-segmental Vitiligo |
| NCT05206591 CAIN457X12301 | CAIN457X12301 | Ph 3 | withdrawn | Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Active Peripheral Spondyloarthritis (pSpA). |
| NCT04239859 | PsO1 | Ph 4 | not yet recruiting | Outcomes With Treatment and Withdraw of Secukinumab in Patients With Plaque Psoriasis |
| NCT03131570 results posted | JKR-0937 | Ph 2 | completed | Safety and Efficacy of Secukinumab in Mild Psoriasis |
| NCT03031782 results posted | CAIN457F2304 2016-003761-26 | Ph 3 | completed | Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA) |
| NCT02696031 PREVENT results posted | CAIN457H2315 | Ph 3 | completed | Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis |
| NCT04571567 | GCO 18-2408 CAIN457AUS16T | Ph 4 | completed | A Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-VI With Moderate to Severe Plaque Psoriasis |
| NCT03342573 | 16-006987 | Ph 1 | completed | Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris |
| NCT03344640 results posted | CAIN457X2201 2017-003099-30 | Ph 2 | completed | Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy |
| NCT03866317 | 2019P000403 | Ph 2 | withdrawn | A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus |
| NCT03041038 results posted | CAIN457AUS05T | Ph 2 | completed | The Efficacy and Safety of Secukinumab in Patients With Ichthyoses |
Showing 50 of 87 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
COSENTYX FDA Label Details
Indications & Usage
FDA Label (PDF)COSENTYX is indicated for the treatment of Moderate to severe plaque psoriasis in patients 6 years and older; Active psoriatic arthritis in patients 2 years and older; Active ankylosing spondylitis in adults; Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults; Active enthesitis-related arthritis in pediatric patients 4 years and older; Moderate to severe hidradenitis suppurativa in adults.
Pro Intelligence Preview
Deep insights for COSENTYX
Revenue Insights
- • Q4-2025: $1.8B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • Generic/biosimilar risk
Trial Analysis
- • 91 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment