Taltz

(Ixekizumab)

ApprovedMonoclonal antibody

Ixekizumab is used to treat inflammatory conditions like psoriasis, psoriatic arthritis, and ankylosing spondylitis by reducing the immune system's inflammatory response that causes joint pain, swelling, and skin problems.[2] Taltz is currently approved and in use across 13 indications[4].[1]

Taltz is one of 293 monoclonal antibody programs targeting Pustular Psoriasis. It is currently in Approved.

Indications

Total Trials

Active Trials

292

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Pustular PsoriasisUnknown

Immune System DiseaseUnknown

Rheumatic DiseaseRecruiting

Juvenile Psoriatic ArthritisActive, not recruiting

Psoriatic ArthritisCompleted

PsoriasisCompleted

Atopic DermatitisNot yet recruiting

Guttate PsoriasisNot yet recruiting

UveitisUnknown status

Generalized Pustular PsoriasisCompleted

Pustular PsoriasisPreclinical

Unknown

Immune System DiseasePreclinical

Unknown

Rheumatic DiseasePhase 2

Recruiting

Juvenile Psoriatic ArthritisPhase 3

Active, not recruiting

Psoriatic ArthritisApproved

Completed

PsoriasisApproved

Completed

Atopic DermatitisApproved

Not yet recruiting

Guttate PsoriasisPhase 3

Not yet recruiting

UveitisApproved

Unknown status

Generalized Pustular PsoriasisApproved

Completed

Showing 10 of 13 indications

Competition

Competitive Landscape

127 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Taltz

Eli Lilly

Approved

1 2

Cytosar

Teva

Phase 3

1 3

Fludara

Sanofi

Phase 3

1 4

Adtralza

LEO Pharma

Phase 3

16 5

Amlitelimab

Sanofi

Phase 3

2 6

DUPIXENT

Regeneron

Phase 3

1 7

Certolizumab

Johnson & Johnson

Phase 3

1 8

Jaktinib

SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase 3

4 9

ICP-332

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

2 10

VC005

JJiangsu vcare pharmaceutical technology co., LTD

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Psoriasis

NCT06945107

Q2 2027

Recruiting

Depressive Symptoms

NCT06786936

Phase 1Not yet recruiting

Study completion

NCT07789964

Q4 2027

Phase 2Recruiting

Diabetes

NCT04589325

Post-ApprovalRecruiting

Psoriasis

NCT04537689

N/ANot yet recruiting

Psoriasis

NCT06811558

Clinical

Trials by Indication[1]

Psoriasis20 trials

Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03073200·201 enrolled

A Phase 3 Study in Participants With Moderate to Severe Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01474512·1,296 enrolled

Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

Unknown status·SShanghai Yueyang Integrated Medicine Hospital·N/A·NCT05042635·90 enrolled

Show 17 more trials

A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01597245·1,224 enrolled

Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01777191·204 enrolled

A Study of Ixekizumab in Participants With Plaque Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02993471·28 enrolled

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02634801·162 enrolled

A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy

Active, not recruiting·IInnovent Biopharmaceutical Technology (Hangzhou) Co., LTD.·Phase 3·NCT06945107·308 enrolled

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02561806·302 enrolled

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Completed·RRadboud University Medical Center·Phase 4·NCT04340076·244 enrolled

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02718898·149 enrolled

A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03364309·438 enrolled

A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01646177·1,346 enrolled

A Study in Japanese Participants With Moderate-to-Severe Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01624233·91 enrolled

A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02513550·1,257 enrolled

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT03573323·1,027 enrolled

Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis

Recruiting·SSingapore General Hospital·Phase 4·NCT04537689·40 enrolled

A Study in Participants With Moderate to Severe Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01107457·142 enrolled

A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02387801·12 enrolled

Ixekizumab Versus Secukizumab in Over 70-year-old Patients with Psoriasis

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT06811558·100 enrolled

Psoriatic Arthritis8 trials

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT04610476·270 enrolled

A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02349295·363 enrolled

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06588296·279 enrolled

Show 5 more trials

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT03151551·566 enrolled

A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT05855967·250 enrolled

A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02584855·394 enrolled

Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis

Not yet recruiting·NNHS Greater Glasgow and Clyde·N/A·NCT07443956·45 enrolled

A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01695239·417 enrolled

Arthritis5 trials

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02757352·303 enrolled

A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT04285229·147 enrolled

A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03129100·773 enrolled

Show 2 more trials

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02696785·341 enrolled

A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02696798·316 enrolled

ART3 trials

Study of Ixekizumab in Healthy Participants

Terminated· Eli Lilly logo

Eli Lilly·Phase 1·NCT03848403·70 enrolled

A Study of Ixekizumab in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT03848416·99 enrolled

A Study of Two Formulations of Ixekizumab in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT04259346·245 enrolled

COVID-192 trials

Survival TRial Using CytoKines in COVID-19 (STRUCK Trial)

Completed·UUniversity of Sao Paulo·Phase 3·NCT04724629·60 enrolled

COVID-19 VaccinE Response in Rheumatology Patients

Completed·JJeffrey Curtis·Phase 4·NCT05080218·841 enrolled

19 more indications

Diabetes1 trial

Ixekizumab Diabetes Intervention Trial (I-DIT)

Recruiting·GGöteborg University·Phase 2·NCT04589325·127 enrolled

Generalized Pustular Psoriasis1 trial

A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT03942042·12 enrolled

Lichen Planopilaris1 trial

Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris

Completed·UUniversity of New Mexico·Phase 1·NCT05030415·9 enrolled

Uveitis1 trial

Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study

Unknown status·MMassachusetts Eye Research and Surgery Institution·Phase 4·NCT06085079·20 enrolled

Depressive Symptoms1 trial

Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms

Recruiting·NNHS Greater Glasgow and Clyde··NCT06786936·50 enrolled

Pyoderma Gangrenosum1 trial

An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum

Completed·OOhio State University·Phase 2·NCT03137160·4 enrolled

Psoriasis Vulgaris1 trial

A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT03073213·32 enrolled

Guttate Psoriasis1 trial

Efficacy and Safety of Ixekizumab in Patients with Refractory Guttate Psoriasis

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2/3·NCT06374979·50 enrolled

Ankylosing Spondylitis1 trial

Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)

Withdrawn· Eli Lilly logo

Eli Lilly·Phase 3·NCT01870284

Overweight1 trial

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06588283·250 enrolled

Atopic Dermatitis1 trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Treatment Resistant Depression1 trial

Targeting IL-17A for Treatment-Resistant Depression

Completed·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT04979910·7 enrolled

Pityriasis Rubra Pilaris1 trial

Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

Completed·OOregon Health and Science University·Phase 2·NCT03485976·12 enrolled

Immune Response1 trial

A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02543918·84 enrolled

Bullous Pemphigoid1 trial

Ixekizumab in the Treatment of Bullous Pemphigoid

Completed·MMayo Clinic·Phase 2·NCT03099538·4 enrolled

Tics1 trial

Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects

Active, not recruiting·CCelltrion·Phase 1·NCT07200986·218 enrolled

Juvenile Psoriatic Arthritis1 trial

Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04527380·101 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Unspecified1 trial

A Phase I, Randomised, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Ixekizumab (SB35 and Taltz) in Healthy Participants

Not yet recruiting·SSamsung Bioepis Co., Ltd.·Phase 1·NCT07789964·174 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 22, 2016

TALTZ

NDA BLA125521

Mar 22, 2016

TALTZ

BLA BLA125521

Jul 5, 2017

TALTZ

NDA BLA125521

Dec 1, 2017

TALTZ

NDA BLA125521

Mar 16, 2018

TALTZ

NDA BLA125521

Apr 19, 2018

TALTZ

NDA BLA125521

May 17, 2018

TALTZ

NDA BLA125521

Aug 23, 2019

TALTZ

NDA BLA125521

Mar 26, 2020

TALTZ

NDA BLA125521

May 29, 2020

TALTZ

NDA BLA125521

Mar 10, 2021

TALTZ

NDA BLA125521

May 4, 2022

TALTZ

NDA BLA125521

Jul 27, 2022

TALTZ

NDA BLA125521

Sep 13, 2023

TALTZ

NDA BLA125521

Nov 20, 2023

TALTZ

NDA BLA125521

Aug 20, 2024

TALTZ

NDA BLA125521

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Ixekizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Taltz drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ixekizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ixekizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA125521). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Ixekizumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: IL-17A Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Eli Lilly

Key Publications[6]

Ixekizumab Versus Adalimumab in Psoriatic Arthritis: SPIRIT-H2H

Lancet RheumatolAug 11, 2022DOI: 10.1016/S2665-9913(22)00187-3

Taltz

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Psoriasis20 trials

Psoriatic Arthritis8 trials

Arthritis5 trials

ART3 trials

COVID-192 trials

Diabetes1 trial

Generalized Pustular Psoriasis1 trial

Lichen Planopilaris1 trial

Uveitis1 trial

Depressive Symptoms1 trial

Pyoderma Gangrenosum1 trial

Psoriasis Vulgaris1 trial

Guttate Psoriasis1 trial

Ankylosing Spondylitis1 trial

Overweight1 trial

Atopic Dermatitis1 trial

Treatment Resistant Depression1 trial

Pityriasis Rubra Pilaris1 trial

Immune Response1 trial

Bullous Pemphigoid1 trial

Tics1 trial

Juvenile Psoriatic Arthritis1 trial

Rheumatic Disease1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News