Data updated: May 26, 2026
EBGLYSS (lebrikizumab-lbkz)
Interleukin-13 Antagonists Genetically Validated
Trial Activity: Stable 12 active trials
Fast Track
Immunology
Approved 2024-09-13
EBGLYSS is indicated for the treatment of Atopic Dermatitis.
How EBGLYSS Works
Lebrikizumab-lbkz is a monoclonal antibody that binds to interleukin-13 (IL-13), a cytokine that drives the Type 2 inflammation associated with atopic dermatitis. By binding to IL-13, the drug inhibits signaling through the IL-4Rα/IL-13Rα1 receptor complex, which prevents the release of proinflammatory cytokines, chemokines, and IgE. While it blocks this inflammatory signaling, the drug-bound IL-13 can still bind to the IL-13Rα2 receptor to allow for the natural internalization and clearance of the cytokine.
Development Insights
Eli Lilly and Company conducting 17 trials (39%)
15 indications explored (Broad Platform)
→ atopic dermatitis (19 trials)
→ asthma (13 trials)
→ eczema (6 trials)
1
Indication
--
Phase 3 Trials
1
Years on Market
Details
- Status
- Prescription
- First Approved
- 2024-09-13
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
EBGLYSS Approval History
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2024 to 2025
What EBGLYSS Treats
1 indicationsEBGLYSS is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atopic Dermatitis
Source: FDA Label
EBGLYSS Target & Pathway
ProTarget
EBGLYSS Competitive Set
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Direct competitors
1
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Indication competitors
10
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Upgrade to Pro 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 EBGLYSS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications EBGLYSS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to EBGLYSS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
40 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05735483 ADorable-2 | 18266 J2T-MC-KGBJ/DRM06-AD16, 2022-501478-21-00 | Ph 3 | enrolling by invitation | A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis |
| NCT07542483 LUMINE | M-27501-30 2025-522403-17-00 | Ph 3 | not yet recruiting | A Study of Lebrikizumab in Adults With Nummular Eczema |
| NCT06526182 ADhope 2 | M-17923-34 2023-508235-31 | Ph 3 | active not recruiting | A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis |
| NCT06921759 ADtouch | 27349 J2T-MC-KGCD | Ph 3 | active not recruiting | A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis |
| NCT07006792 ADsolve | 27407 J2T-MC-KGCE | Ph 4 | recruiting | A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden |
| NCT07471932 | M-27312-01 2025-523328-31-00, CHDR2521 | Ph 1 | recruiting | A Study of LAD106 in Healthy Adult Participants |
| NCT05372419 ADmirable results posted | 18500 J2T-MC-KGBP | Ph 3 | completed | 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 |
| NCT05369403 ADapt results posted | 18499 J2T-MC-KGBO | Ph 3 | completed | A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab |
| NCT05559359 ADorable-1 | 18265 J2T-MC-KGBI, DRM06-AD13 | Ph 3 | active not recruiting | A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT04392154 ADjoin results posted | 17789 2020-001211-24, J2T-DM-KGAA | Ph 3 | completed | Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin) |
| NCT06280716 | 18817 J2T-MC-KGBW | Ph 3 | active not recruiting | A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis |
| NCT06243198 results posted | 18791 J2T-MC-KGBV | Ph 1 | completed | A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants |
| NCT06906497 ADfind | HUM00261982 | Ph 4 | recruiting | Lebrikizumab in Moderate-to-severe Atopic Dermatitis |
| NCT05149313 ADvantage results posted | M-17923-30 2021-002967-23 | Ph 3 | completed | 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 |
| NCT05916365 ADlong | M-17923-32 2022-502575-30-00 | Ph 3 | completed | Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis |
| NCT05990725 ADhope | M-17923-33 2023-505558-16 | Ph 3 | active not recruiting | Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis |
| NCT04840901 results posted | 17955 J2T-MC-KGBG | Ph 1 | completed | A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants |
| NCT04626297 results posted | 17946 J2T-MC-KGAK, 2020-002572-12 | Ph 3 | completed | A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA) |
| NCT04760314 ADhere-J results posted | 17953 J2T-JE-KGAL | Ph 3 | completed | A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis |
| NCT04178967 ADvocate2 results posted | 17802 2019-002933-12, J2T-DM-KGAC | Ph 3 | completed | Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis |
| NCT04250350 ADore results posted | 17804 J2T-DM-KGAE, DRM06-AD17 | Ph 3 | completed | Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis |
| NCT04146363 results posted | 17801 2019-002932-10, J2T-DM-KGAB | Ph 3 | completed | Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1) |
| NCT04250337 ADhere results posted | 17803 2019-004300-34, J2T-DM-KGAD | Ph 3 | completed | Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis. |
| NCT03443024 results posted | 17826 J2T-DM-KGAF, DRM06-AD01 | Ph 2 | completed | A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis |
| NCT02465606 | GS29735 | Ph 2 | completed | A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis |
| NCT01872689 results posted | GB28547 2013-001163-24 | Ph 2 | completed | A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) |
| NCT02546869 | WB29906 | Ph 3 | withdrawn | A Single-Arm Study to Evaluate Administration of Lebrikizumab by Participants or Caregivers in the Home Setting |
| NCT02340234 | GS29250 2014-000049-56 | Ph 2 | completed | A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis |
| NCT02099656 | GB29260 2014-000275-14 | Ph 2 | completed | A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma |
| NCT02546700 | WB29804 2015-001122-42 | Ph 2 | completed | A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) |
| NCT01987492 | WB28182 2012-000190-24 | Ph 2 | completed | A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma |
| NCT01868061 | GB28689 2013-000176-15 | Ph 3 | completed | A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication |
| NCT01867125 | GB28688 2013-000175-33 | Ph 3 | completed | A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication |
| NCT01875003 | WB28183 2012-000180-25 | Ph 3 | completed | A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication |
| NCT01545453 | GB27864 2011-004205-24 | Ph 2 | completed | A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE) |
| NCT01423318 | GB25741 | Ph 1 | completed | A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers |
| NCT02104674 | WA29249 | Ph 3 | completed | A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma |
| NCT02486809 | GP29651 | Ph 1 | completed | A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD) |
| NCT01545440 | GB27862 2011-004218-41 | Ph 2 | completed | A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE) |
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Pro Active Pipeline
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
EBGLYSS FDA Label Details
Indications & Usage
FDA Label (PDF)EBGLYSS is indicated for the treatment of Atopic Dermatitis.
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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