TALTZ (ixekizumab)
TALTZ is indicated for the treatment of Moderate-to-severe plaque psoriasis in patients 6 years of age and older; Active psoriatic arthritis in adults; Active ankylosing spondylitis in adults; Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults.
How TALTZ Works
Ixekizumab is a humanized monoclonal antibody that selectively binds to the interleukin 17A (IL-17A) cytokine. By binding to this cytokine, the drug prevents it from interacting with the IL-17 receptor found on various cells. This action inhibits the release of proinflammatory cytokines and chemokines that are typically involved in normal inflammatory and immune responses. Through this targeted blockade, the medication reduces the inflammation associated with specific autoimmune and musculoskeletal disorders.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-03-22
- Patent Cliff
- 2027
- Revenue
- $1.0B (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TALTZ Approval History
What TALTZ Treats
4 indicationsTALTZ is approved for 4 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Moderate-to-severe plaque psoriasis in patients 6 years of age and older
- Active psoriatic arthritis in adults
- Active ankylosing spondylitis in adults
- Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults
TALTZ 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.
TALTZ 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 TALTZ's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TALTZ treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TALTZ
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
44 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06588296 TOGETHER-PsA | 27241 I1F-MC-RHDB | Ph 3 | completed | Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight |
| NCT04589325 I-DIT | IDIT001 | Ph 2 | active not recruiting | Ixekizumab Diabetes Intervention Trial (I-DIT) |
| 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 |
| NCT04527380 results posted | 16694 I1F-MC-RHCG, 2018-000681-10 | Ph 3 | active not recruiting | 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 |
| NCT04340076 BeNeBio | 80-85200-98-18562 2019-004230-42 | Ph 4 | completed | Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis |
| NCT05309616 | 2000031202 No NIH funding | Ph 2 | active not recruiting | Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis |
| NCT06588283 TOGETHER-PsO | 27243 I1F-MC-RHDC | Ph 3 | active not recruiting | Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT07200986 | CT-P52 1.1 | Ph 1 | active not recruiting | Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT05855967 results posted | 18528 I1F-IN-RHCZ | Ph 4 | completed | A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India |
| NCT04979910 results posted | GCO 20-1909 | Ph 2 | completed | Targeting IL-17A for Treatment-Resistant Depression |
| NCT05080218 COVER | COVER-Main | Ph 4 | completed | COVID-19 VaccinE Response in Rheumatology Patients |
| NCT06374979 | 2024-0047 | Ph 2, Ph 3 | not yet recruiting | Efficacy and Safety of Ixekizumab in Patients with Refractory Guttate Psoriasis |
| NCT03137160 results posted | 2017H0045 | Ph 2 | completed | An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum |
| NCT04285229 results posted | 16721 I1F-MC-RHCH | Ph 3 | completed | A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis |
| NCT03848403 results posted | 17139 I1F-MC-RHCS | Ph 1 | terminated | Study of Ixekizumab in Healthy Participants |
| NCT04537689 | PsO_IXE | Ph 4 | recruiting | Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis |
| NCT04724629 STRUCK | 402422/2020-1 | Ph 3 | completed | Survival TRial Using CytoKines in COVID-19 (STRUCK Trial) |
| NCT03129100 results posted | 16181 I1F-MC-RHBY, 2016-002634-69 | Ph 3 | completed | A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis |
| NCT04259346 results posted | 17151 I1F-MC-RHCU | Ph 1 | completed | A Study of Two Formulations of Ixekizumab in Healthy Participants |
| NCT03073200 Ixora-peds results posted | 16367 I1F-MC-RHCD, 2016-003331-38 | Ph 3 | completed | Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis |
| NCT03942042 results posted | 17154 I1F-JE-RHCV | Ph 4 | completed | A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis |
| NCT03364309 results posted | 14438 I1F-MC-RHBH | Ph 3 | completed | A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis |
| NCT03151551 SPIRIT-H2H results posted | 16687 I1F-MC-RHCF, 2016-004585-25 | Ph 4 | completed | A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis |
| NCT03573323 IXORA-R results posted | 17119 I1F-MC-RHCR | Ph 4 | completed | A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis |
| NCT03073213 results posted | 15371 I1F-MC-RHBN | Ph 1 | completed | A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris |
| NCT03485976 results posted | STUDY00018031 | Ph 2 | completed | Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP) |
| NCT03848416 results posted | 17140 I1F-MC-RHCT | Ph 1 | completed | A Study of Ixekizumab in Healthy Participants |
| NCT02696798 COAST-W results posted | 16179 I1F-MC-RHBW, 2015-003937-84 | Ph 3 | completed | A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis |
| NCT02561806 IXORA-S results posted | 16012 I1F-MC-RHBS, 2015-000892-28 | Ph 3 | completed | A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis |
| NCT02513550 IXORA-P results posted | 15988 I1F-MC-RHBP, 2015-000190-12 | Ph 3 | completed | A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis |
| NCT03099538 results posted | IRB#16-008302 | Ph 2 | completed | Ixekizumab in the Treatment of Bullous Pemphigoid |
| NCT02757352 COAST-X results posted | 16180 I1F-MC-RHBX, 2015-003938-27 | Ph 3 | completed | A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis |
| NCT02696785 COAST-V results posted | 16178 I1F-MC-RHBV, 2015-003932-11 | Ph 3 | completed | A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis |
| NCT02584855 SPIRIT P3 results posted | 14518 I1F-MC-RHBF, 2015-002433-22 | Ph 3 | completed | A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis |
| NCT02634801 results posted | 16190 I1F-EW-RHBZ, 2015-002649-69 | Ph 3 | completed | A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment |
| NCT01107457 results posted | 12060 I1F-MC-RHAJ | Ph 2 | completed | A Study in Participants With Moderate to Severe Psoriasis |
| NCT02387801 results posted | 15454 I1F-US-RHBO | Ph 3 | completed | A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis |
| NCT02718898 IXORA-Q results posted | 16010 I1F-MC-RHBQ, 2015-002628-14 | Ph 3 | completed | A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis |
| NCT02993471 results posted | 16126 I1F-MC-RHBU | Ph 1 | completed | A Study of Ixekizumab in Participants With Plaque Psoriasis |
| NCT01695239 SPIRIT-P1 results posted | 13731 I1F-MC-RHAP | Ph 3 | completed | A Study of Ixekizumab in Participants With Active Psoriatic Arthritis |
| NCT02543918 results posted | 16202 I1F-MC-RHCA | Ph 1 | completed | A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants |
| NCT01870284 SPIRIT A1 | 13650 I1F-MC-RHAO | Ph 3 | withdrawn | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) |
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.
TALTZ FDA Label Details
Indications & Usage
FDA Label (PDF)TALTZ is indicated for the treatment of Moderate-to-severe plaque psoriasis in patients 6 years of age and older; Active psoriatic arthritis in adults; Active ankylosing spondylitis in adults; Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults.
Pro Intelligence Preview
Deep insights for TALTZ
Revenue Insights
- • Q4-2025: $1.0B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • Generic/biosimilar risk
Trial Analysis
- • 44 total trials
- • Stage: Stable
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