EBGLYSS

(Lebrikizumab)

ApprovedMonoclonal antibody

EBGLYSS is a monoclonal antibody that works as a IL-13 Inhibitor.[2] It is being used across 6 indications, with its most advanced program in Approved.[1]

EBGLYSS is one of 107 monoclonal antibody programs targeting Atopic Eczema. It is currently in Approved.

Indications

Total Trials

Active Trials

106

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Atopic EczemaUnknown

Eczematoid DermatitisUnknown

Skin DiseaseActive, not recruiting

Nummular EczemaRecruiting

Prurigo NodularisNot yet recruiting

Atopic DermatitisRecruiting

Atopic EczemaPreclinical

Unknown

Eczematoid DermatitisPreclinical

Unknown

Skin DiseasePreclinical

Active, not recruiting

Nummular EczemaPhase 3

Recruiting

Prurigo NodularisPhase 2

Not yet recruiting

Atopic DermatitisApproved

Recruiting

Competition

Competitive Landscape

127 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

EBGLYSS

Eli Lilly

Approved

23 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

Q4 2026

Phase 3Active, not recruiting

Atopic Dermatitis

NCT05559359

Q2 2027

Phase 3Recruiting

Atopic Dermatitis

NCT06526182

Q1 2028

Phase 2Not yet recruiting

Prurigo Nodularis

NCT07620561

Q3 2028

ApprovedActive, not recruiting

Atopic Dermatitis

NCT06906497

Clinical

Trials by Indication[1]

Atopic Dermatitis23 trials

A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine

Completed·AAlmirall, S.A.·Phase 3·NCT05149313·331 enrolled

A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06280716·301 enrolled

A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT04760314·286 enrolled

Show 20 more trials

Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT04250350·206 enrolled

A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT05369403·86 enrolled

A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT05372419·90 enrolled

A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT04626297·254 enrolled

A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT03443024·280 enrolled

A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

Recruiting·AAlmirall, S.A.·Phase 3·NCT06526182·520 enrolled

Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT04392154·1,153 enrolled

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

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

A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis

Completed· Roche logo

Roche·Phase 2·NCT02465606·55 enrolled

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT04250337·228 enrolled

Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT06444165·55 enrolled

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT04178967·445 enrolled

A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden

Recruiting· Eli Lilly logo

Eli Lilly·Phase 4·NCT07006792·200 enrolled

A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis

Completed· Roche logo

Roche·Phase 2·NCT02340234·212 enrolled

Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis

Active, not recruiting·AAlmirall, S.A.·Phase 3·NCT05916365·200 enrolled

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT04146363·424 enrolled

A Phase IV, Non-randomized, Open-label Multinational Trial to Assess the Mechanism of Action for Lebrikizumab in Moderate-to-severe Atopic Dermatitis

Active, not recruiting·JJohann E Gudjonsson MD PhD·Approved·NCT06906497·48 enrolled

A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Enrolling by invitation· Eli Lilly logo

Eli Lilly·Phase 3·NCT05735483·333 enrolled

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05559359·377 enrolled

A Phase 3b, Open-label Study to Evaluate the Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

Completed·AAlmirall, S.A.·Phase 3·NCT05990725·260 enrolled

Asthma10 trials

A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

Completed· Roche logo

Roche·Phase 2·NCT01987492·230 enrolled

A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma

Completed· Roche logo

Roche·Phase 2·NCT02099656·64 enrolled

A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)

Completed· Roche logo

Roche·Phase 2·NCT01545440·258 enrolled

Show 7 more trials

A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)

Completed· Roche logo

Roche·Phase 2·NCT01545453·205 enrolled

A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids

Completed· Roche logo

Roche·Phase 2·NCT00971035·210 enrolled

A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids

Completed· Roche logo

Roche·Phase 2·NCT00930163·218 enrolled

A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication

Completed· Roche logo

Roche·Phase 3·NCT01868061·1,068 enrolled

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Completed· Roche logo

Roche·Phase 3·NCT01867125·1,081 enrolled

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma

Completed· Roche logo

Roche·Phase 3·NCT02104674·313 enrolled

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Lebrikizumab in Adolescent Patients With Uncontrolled Asthma Who Are On Inhaled Corticosteroids and a Second Controller Medication.

Terminated· Roche logo

Roche·Phase 3·NCT01875003·346 enrolled

Skin Disease1 trial

Molecular Signatures in Inflammatory Skin Disease

Recruiting·PProf. Dr. Stephan Weidinger··NCT03358693·300 enrolled

Adult1 trial

A Study of LAD106 in Healthy Adult Participants

Recruiting·AAlmirall, S.A.·Phase 1·NCT07471932·93 enrolled

ART1 trial

A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT04840901·242 enrolled

9 more indications

Tics1 trial

A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06243198·24 enrolled

Airway obstruction1 trial

A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

Completed· Roche logo

Roche·Phase 2·NCT00781443·29 enrolled

Idiopathic Pulmonary Fibrosis1 trial

A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Completed· Roche logo

Roche·Phase 2·NCT01872689·505 enrolled

CAR1 trial

A Single-Arm Study to Evaluate Administration of Lebrikizumab by Participants or Caregivers in the Home Setting

Withdrawn· Roche logo

Roche·Phase 3·NCT02546869

Chronic Obstructive Pulmonary Disease1 trial

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Chronic Obstructive Pulmonary Disease and a History of Exacerbations

Completed· Roche logo

Roche·Phase 2·NCT02546700·309 enrolled

Prurigo Nodularis1 trial

Evaluating the Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients: A 24-Week Study

Not yet recruiting·UUniversity of Maryland, Baltimore·Phase 2·NCT07620561·15 enrolled

Atopic Hand and Foot Dermatitis1 trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT06921759·221 enrolled

Nummular Eczema1 trial

A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema Who Are Not Adequately Controlled With Topical Corticosteroids or When This Treatment is Not Medically Advisable (LUMINE)

Recruiting·AAlmirall, S.A.·Phase 3·NCT07542483·270 enrolled

Unspecified2 trials

A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)

Completed· Roche logo

Roche·Phase 1·NCT02486809·176 enrolled

A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01423318·60 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 13, 2024

EBGLYSS

BLA BLA761306

Sep 13, 2024

EBGLYSS

NDA BLA761306

May 22, 2025

EBGLYSS

NDA BLA761306

Oct 28, 2025

EBGLYSS

NDA BLA761306

Jun 9, 2026

EBGLYSS

NDA BLA761306

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for Lebrikizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lebrikizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lebrikizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA761306). U.S. Food & Drug Administration.
[5]
PubMed — 1 publication indexed for Lebrikizumab. U.S. National Library of Medicine.
[6]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: IL-13 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: Eli Lilly

Key Publications[5]

Lebrikizumab in Moderate-to-Severe Atopic Dermatitis: ADvocate-1 and -2

N Engl J MedMar 23, 2023DOI: 10.1056/NEJMoa2210958

EBGLYSS

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q1 2028

Q3 2028

Trials by Indication[1]

Atopic Dermatitis23 trials

Asthma10 trials

Skin Disease1 trial

Adult1 trial

ART1 trial

Tics1 trial

Airway obstruction1 trial

Idiopathic Pulmonary Fibrosis1 trial

CAR1 trial

Chronic Obstructive Pulmonary Disease1 trial

Prurigo Nodularis1 trial

Atopic Hand and Foot Dermatitis1 trial

Nummular Eczema1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Key Publications[5]

Related News