Drugs / Lebrikizumab
Lebrikizumab
also known as
LY3650150 · MILR1444A · LEB · Ebglyss · Lebrikizumab-lbkz · PRO-301444 · PRO-301444 RG-3637 · RO-5490255 · +1 more
Monoclonal antibody targets IL13
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed atopic eczema 6 milestones | |||||
| Filed | EU (EMA) | Ebglyss | atopic eczema | 2026-07-20 | “today announced that the European Medicines Agency (EMA) has accepted the submission of the extension of the Marketing Authorisation Application (MAA) of Ebglyss® (lebrikizumab)” almirall.com ↗ |
| Filed | US (FDA) | — | atopic eczema | 2024-04-30 | “Resubmission of lebrikizumab for adult and adolescent patients with moderate-to-severe atopic dermatitis in the U.S.” lilly.com ↗ “The submission of lebrikizumab for the treatment of moderate-to-severe atopic dermatitis to the FDA” lilly.com ↗ |
| Rejected (CRL) | US (FDA) | — | atopic eczema | 2023-10-02 | “the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the lebrikizumab biologic license application (BLA)” lilly.com ↗ “The FDA's issuance of a complete response letter for lebrikizumab for the treatment of moderate-to-severe atopic dermatitis” lilly.com ↗ |
| Filed | EU (EMA) | — | atopic eczema | 2022-10-28 | “the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for lebrikizumab for the treatment of moderate to severe atopic dermatitis.” almirall.com ↗ “In October 2022, Almirall submitted a Marketing Authorisation Application (MAA) to the EMA for Lebrikizumab” almirall.com ↗ “Almirall submitted a marketing authorization application to the EMA for lebrikizumab” almirall.com ↗ |
| Filed | Japan (PMDA) | — | atopic eczema | — | “regulatory submissions of tirzepatide for obesity in the EU and lebrikizumab for atopic dermatitis in Japan.” lilly.com ↗ |
| Filed | Other | — | atopic eczema | — | “In Switzerland, Almirall submitted the MAA in June 2023” almirall.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | EBGLYSS | — | 2026-06-09 | fda.gov ↗ |
| Approved | US (FDA) | EBGLYSS | — | 2024-09-13 | fda.gov ↗ |
| Approved | EU (EMA) | Ebglyss | — | 2023-11-16 | europa.eu ↗ |
Trials 46
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06243198 | Mar → Sep 2024 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04840901 | Jun 2021 → Feb 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01423318 | Aug 2011 → Feb 2012 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00441818 | May 2006 → Jun 2007 | Hodgkins lymphoma | Tanox | Unknown | No outcome recorded |
| Phase 213 trials · 2 met primary · 3 missed | ||||||
| Phase 2 | NCT07620561 | Sep 2026 → Dec 2027 expected | prurigo nodularis | University of Maryland, Baltimore | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03443024 | Jan 2018 → Feb 2019 | atopic eczema | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT02546700 | Sep 2015 → Nov 2016 | chronic obstructive pulmonary disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02465606 | Jul 2015 → May 2016 | atopic eczema | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02340234 | May 2015 → Apr 2016 | atopic eczema | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02099656 | Nov 2014 → Oct 2016 | asthma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 2 | NCT01987492 | Feb 2014 → Dec 2016 | asthma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01872689 | Oct 2013 → Jul 2017 | idiopathic pulmonary fibrosis | Hoffmann-La Roche | Completed | Missed primary |
| Phase 2 | NCT01545453 | Mar 2012 → Jul 2013 | asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01545440 | Mar 2012 → Mar 2013 | asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00971035 | Nov 2009 → Dec 2010 | asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00930163 | Jul 2009 → Jul 2010 | asthma | Genentech, Inc. | Completed | Met primary |
| Phase 2 | NCT00781443 | Dec 2008 → Nov 2009 | allergic asthma | Genentech, Inc. | Completed | Missed primary |
| Phase 325 trials · 8 met primary · 2 missed | ||||||
| Phase 3 | NCT07542483 | Apr 2026 → Aug 2028 expected | — | Almirall, S.A. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06921759 | Apr 2025 → May 2026 overdue | atopic eczema | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 3 | NCT06526182 | Jul 2024 → Apr 2027 expected | atopic eczema | Almirall, S.A. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06338995 | Apr 2024 → May 2027 expected | chronic rhinosinusitis | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT06339008 | Apr 2024 → Sep 2026 overdue | perennial allergic rhinitis | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06280716 | Apr 2024 → Sep 2025 overdue | atopic eczema | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05990725 | Nov 2023 → Jun 2025 | atopic eczema | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT05916365 | May 2023 → Apr 2026 | atopic eczema | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT05735483 | Mar 2023 → Dec 2027 expected | atopic eczema | Eli Lilly and Company | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05372419 | Jan 2023 → May 2024 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT05369403 | Dec 2022 → Jan 2024 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT05559359 | Oct 2022 → Jan 2026 overdue | atopic eczema | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 3 | NCT05149313 | Dec 2021 → Jan 2023 | atopic eczema | Almirall, S.A. | Completed | Met primary |
| Phase 3 | NCT04760314 | Mar 2021 → Jul 2022 | atopic eczema | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT04626297 | Nov 2020 → Aug 2022 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT04392154 | Jun 2020 → Jul 2024 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT04250350 | Feb 2020 → Apr 2022 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT04250337 | Feb 2020 → Aug 2021 | atopic eczema | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT04178967 | Oct 2019 → Jul 2021 | atopic eczema | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT04146363 | Sep 2019 → Jun 2021 | atopic eczema | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02546869 | Sep 2015 → Jun 2016 | asthma | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 3 | NCT02104674 | Jun 2014 → Jan 2016 | asthma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT01875003 | Aug 2013 → Dec 2016 | asthma | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01868061 | Jul 2013 → Jan 2017 | asthma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT01867125 | Jul 2013 → Dec 2016 | asthma | Hoffmann-La Roche | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07856134 | Nov 2026 → Aug 2027 expected | atopic eczema | Forefront Dermatology S.C | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06906497 | Jul 2025 → Jul 2027 expected | atopic eczema | Johann E Gudjonsson MD PhD | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07006792 | Jun 2025 → May 2026 overdue | atopic eczema | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT07471932 Comparator | Feb 2026 → May 2027 expected | — | Almirall, S.A. | Recruiting | No outcome recorded |
| Phase 3 | NCT06444165 Background | Jun 2024 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 45
| Date | Issuer | Release |
|---|---|---|
| 2026-10-05 | Eli Lilly and Company | Results Lilly to present new data across its dermatology portfolio with 21 presentations at Fall Clinical 2026, in pursuit of advancing care for chronic skin conditions lilly.com ↗
Latest EBGLYSS (lebrikizumab-lbkz) data reinforce durable disease control, less frequent maintenance dosing and reduced topical treatment use in patients with moderate-to-severe atopic dermatitis |
| 2026-10-01 | Almirall, S.A. | Results EADV 2026: long-term disease control for up to five years in patients with moderate-to-severe atopic dermatitis treated with lebrikizumab almirall.com ↗
Almirall, S.A. (ALM), a global biopharmaceutical company focused on medical dermatology, today announced long-term results from ADlong, a Phase 3b open-label extension study evaluating the efficacy and safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis (AD). |
| 2026-09-30 | Almirall, S.A. | Results Almirall advances skin science and shares new evidence across its dermatology portfolio at EADV 2026 almirall.com ↗ |
| 2026-09-30 | Eli Lilly and Company | Results New Phase 3b data show Lilly's EBGLYSS (lebrikizumab-lbkz) delivered significant and rapid improvements in skin clearance, itch, pain, and patient satisfaction in people with moderate-to-severe hand and foot atopic dermatitis lilly.com ↗
EBGLYSS monotherapy met its primary endpoint with more than half of patients achieving clear or almost clear skin on their hands and feet (HF-IGA 0/1) by Week 16 |
| 2026-07-20 | Almirall, S.A. | Regulatory Almirall announces EMA acceptance for filing of paediatric registration of Ebglyss (lebrikizumab) in atopic dermatitis in children 6 months and older almirall.com ↗ |
| 2026-06-09 | Eli Lilly and Company | Regulatory FDA approves Lilly's EBGLYSS® (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis lilly.com ↗ |
| 2026-03-27 | Almirall, S.A. | Results Lebrikizumab delivered long-term disease control for up to four years in patients with moderate-to-severe atopic dermatitis almirall.com ↗
Lebrikizumab delivered near-complete skin clearance and itch relief for up to four years for patients with moderate-to-severe atopic dermatitis, while maintaining its established safety profile. |
| 2026-03-27 | Eli Lilly and Company | Results Lilly's EBGLYSS (lebrikizumab-lbkz) delivered up to four years of durable disease control for patients with moderate-to-severe atopic dermatitis lilly.com ↗ |
| 2026-03-16 | Almirall, S.A. | Results Lebrikizumab delivered significant skin clearance and improved disease severity in children with moderate-to-severe atopic dermatitis almirall.com ↗
Lebrikizumab met both co-primary and key secondary endpoints, delivering near-complete skin clearance, reduced disease severity, itch relief and improved quality of life at Week 16. |
| 2026-03-16 | Eli Lilly and Company | Results Lilly's EBGLYSS (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive Phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis lilly.com ↗ |
| 2025-10-24 | Eli Lilly and Company | Results Lilly's EBGLYSS (lebrikizumab-lbkz) delivered durable disease control when administered once every eight weeks in patients with moderate-to-severe atopic dermatitis lilly.com ↗
New results show Eli Lilly and Company's (NYSE: LLY) EBGLYSS (lebrikizumab-lbkz) sustained similar levels of skin clearance when administered as a single injection of 250 mg once every eight weeks (Q8W) compared with once every four weeks (Q4W), supporting a potential additional, less frequent maintenance dosing option for more individualized treatment of patients with moderate-to-severe atopic dermatitis. |
| 2025-06-19 | Almirall, S.A. | Results Almirall shows efficacy of biologics with real-world evidence and new patient-centric research on psychological wellbeing at the 2025 International Congress of Dermatology almirall.com ↗ |
| 2025-06-04 | Almirall, S.A. | Results Almirall leads a paradigm shift to holistic patient care in dermatology, applying the WHO-5 well-being index as primary endpoint in clinical trials almirall.com ↗
Results showed that treatment with lebrikizumab combined with topical corticosteroids, revealed significant improvements in psychological well-being as early as week 16 , which were sustained through week 52, reaching levels of wellbeing comparable to the general population. |
| 2025-03-07 | Eli Lilly and Company | Results Lilly's EBGLYSS® (lebrikizumab-lbkz) single monthly maintenance injection achieved completely clear skin at three years in half of patients with moderate-to-severe atopic dermatitis lilly.com ↗
New results show Eli Lilly and Company's (NYSE: LLY) EBGLYSS achieved deep and sustained response for patients with moderate-to-severe atopic dermatitis (eczema) at three years. |
| 2024-10-25 | Eli Lilly and Company | Results Lilly's EBGLYSS™ (lebrikizumab-lbkz) demonstrated meaningful improvement in skin clearance and itch relief in the majority of patients with moderate-to-severe atopic dermatitis who discontinued dupilumab lilly.com ↗
New results show Eli Lilly and Company's (NYSE: LLY) EBGLYSS improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with dupilumab. |
| 2024-09-25 | Almirall, S.A. | Results New data show Almirall´s EBGLYSS® (lebrikizumab) provided sustained disease control for up to three years in more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis almirall.com ↗ |
| 2024-09-25 | Eli Lilly and Company | Results New data show Lilly's EBGLYSS™ (lebrikizumab-lbkz) provided sustained disease control for up to three years in more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis lilly.com ↗
More than 80 percent of adults and adolescents with moderate-to-severe atopic dermatitis who responded to EBGLYSS™ treatment at Week 16 in the ADvocate 1 and 2 monotherapy trials and continued treatment for up to three years experienced sustained skin clearance with monthly maintenance dosing. |
| 2024-09-13 | Eli Lilly and Company | Regulatory FDA Approves Lilly's EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis lilly.com ↗ |
| 2024-07-10 | Almirall, S.A. | Regulatory NICE recommends Ebglyss (lebrikizumab) for use in moderate to severe Atopic Dermatitis in the NHS England in eligible adolescents and adults almirall.com ↗
Almirall S.A. (BME: ALM) , a global biopharmaceutical company dedicated to medical dermatology, announced today that the National Institute for Health and Care Excellence (NICE) has recommended Ebglyss (lebrikizumab) for use in moderate to severe Atopic Dermatitis in the NHS England. |
| 2024-03-10 | Eli Lilly and Company | Results More than two-thirds of people with atopic dermatitis and skin of color experienced skin improvement in a first-of-its-kind lebrikizumab study lilly.com ↗
In this study, treatment with lebrikizumab, an investigational medicine, showed improvement in skin clearance and itch relief. |
| 2023-11-17 | Almirall, S.A. | Regulatory Almirall receives European Commission approval of EBGLYSS® (lebrikizumab) for moderate-to-severe atopic dermatitis almirall.com ↗
The EC approval of lebrikizumab for people suffering with moderate-to-severe AD provides another much-needed treatment option for this challenging disease. |
| 2023-10-20 | Almirall, S.A. | Results Almirall: Nearly 80% of patients with moderate-to-severe atopic dermatitis maintained clear or almost-clear skin with lebrikizumab monthly maintenance dosing at two years almirall.com ↗
The fact that the monthly maintenance dose of lebrikizumab can help nearly 80% of individuals maintain clear or almost clear skin for two years is truly promising. |
| 2023-10-20 | Eli Lilly and Company | Results Nearly 80% of patients with moderate-to-severe atopic dermatitis maintained clear or almost clear skin with Lilly's lebrikizumab monthly maintenance dosing at two years lilly.com ↗ |
| 2023-10-13 | Almirall, S.A. | Results Almirall's lebrikizumab improves signs and symptoms of moderate-to-severe atopic dermatitis (AD) in patients inadequately controlled with or ineligible for cyclosporine almirall.com ↗
Further data presented at the congress showed sustained depth of response in patients that participated in the Phase 3 monotherapy Advocate 1 and 2 studies treated with lebrikizumab over 52 weeks. |
| 2023-10-02 | Eli Lilly and Company | Regulatory U.S. Food and Drug Administration Issues Complete Response Letter for Lebrikizumab Based on Inspection Findings at Third-Party Manufacturer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema). |
| 2023-09-15 | Almirall, S.A. | Regulatory EBGLYSS® (lebrikizumab) receives positive CHMP opinion for moderate-to-severe atopic dermatitis almirall.com ↗
The positive CHMP opinion is now being reviewed by the European Commission (EC). |
| 2023-05-02 | Almirall, S.A. | Results Almirall: Up to 73% of Atopic Dermatitis Patients Taking Lebrikizumab Had Improved or Cleared Skin on Face or Hands in New Analysis almirall.com ↗
An additional secondary analysis further demonstrated lebrikizumab’s stable and long-lasting results at one year of treatment in patients with moderate-to-severe atopic dermatitis (AD), commonly called eczema. |
| 2023-05-01 | Eli Lilly and Company | Results Up to 73% of Atopic Dermatitis Patients Taking Lilly's Lebrikizumab Had Improved or Cleared Skin on Face or Hands in New Analysis lilly.com ↗ |
| 2023-03-31 | Almirall, S.A. | Results Almirall: The New England Journal of Medicine (NEJM) and the British Journal of Dermatology (BJD) publish Ph3 data evaluating lebrikizumab efficacy and safety in moderate-to-severe atopic dermatitis almirall.com ↗
Almirall, S.A. (ALM) , a global biopharmaceutical company focused on medical dermatology, announced today the publication of Week 16 and Week 52 results of ADvocate1 and ADvocate2 by the New England Journal of Medicine (NEJM) and the British Journal of Dermatology (BJD), respectively. |
| 2022-10-28 | Almirall, S.A. | Regulatory Almirall announces EMA acceptance for filing of Marketing Authorization Application (MAA) for lebrikizumab in atopic dermatitis almirall.com ↗
Almirall, S.A. (ALM) , a global biopharmaceutical company focused on skin health, today announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for lebrikizumab for the treatment of moderate to severe atopic dermatitis. |
| 2022-09-08 | Almirall, S.A. | Results Almirall: Lebrikizumab Dosed Every Four Weeks Maintained Durable Skin Clearance in Phase 3 Monotherapy Atopic Dermatitis Trials almirall.com ↗
Lebrikizumab, a high-affinity and potent IL-13 inhibitor, delivered similar results when dosed once every four weeks or once every two weeks after Week 16. |
| 2022-09-08 | Eli Lilly and Company | Results Lebrikizumab Dosed Every Four Weeks Maintained Durable Skin Clearance in Lilly's Phase 3 Monotherapy Atopic Dermatitis Trials lilly.com ↗
New detailed results from Eli Lilly and Company's (NYSE: LLY) Phase 3 monotherapy studies in atopic dermatitis (AD) showed investigational lebrikizumab provided robust and durable improvements in skin clearance and itch for patients who achieved a clinical response* at Week 16 through one year of treatment. |
| 2022-06-07 | Almirall, S.A. | Results Almirall: Eight out of Ten Patients Maintained Skin Clearance at One Year in Lebrikizumab Atopic Dermatitis Monotherapy Trials almirall.com ↗
Additionally, patients treated with lebrikizumab maintained itch relief across the two trials over the one-year period. |
| 2022-06-07 | Eli Lilly and Company | Results Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly's Lebrikizumab Atopic Dermatitis Monotherapy Trials lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced topline results from one-year analyses of the efficacy and safety of lebrikizumab, the company's investigational IL-13 inhibitor for the treatment of patients with moderate-to-severe atopic dermatitis (AD). |
| 2022-04-11 | Almirall, S.A. | Results Almirall: Lebrikizumab Combined with Topical Corticosteroids Showed Significant Improvements in Disease Severity for Atopic Dermatitis almirall.com ↗
Lebrikizumab, an investigational IL-13 inhibitor, also showed improvements in itch, sleep interference, and quality of life when combined with TCS compared to placebo plus TCS. |
| 2022-04-11 | Eli Lilly and Company | Results Lilly's Lebrikizumab Combined with Topical Corticosteroids Showed Significant Improvements in Disease Severity for Atopic Dermatitis lilly.com ↗
Lebrikizumab, an investigational IL-13 inhibitor, also showed improvements in itch, sleep interference, and quality of life when combined with TCS, compared to placebo plus TCS. |
| 2022-03-26 | Eli Lilly and Company | Results Majority of Patients Treated with Lebrikizumab Achieved Skin Clearance in Lilly's Pivotal Phase 3 Atopic Dermatitis Studies lilly.com ↗
Lebrikizumab, an investigational IL-13 inhibitor, also led to clinically meaningful improvements in itch and other important patient-reported outcomes compared to placebo. |
| 2022-03-25 | Almirall, S.A. | Results Almirall: Majority of Patients Treated with Lebrikizumab Achieved Skin Clearance in Pivotal Phase 3 Atopic Dermatitis Studies almirall.com ↗
More than 50 percent of patients with moderate-to-severe atopic dermatitis (AD) experienced at least 75 percent reduction in disease severity (EASI-75*) at 16 weeks when receiving lebrikizumab monotherapy in the ADvocate program, Almirall S.A. (BME: ALM) announced today at the American Academy of Dermatology (AAD) Annual Meeting. |
| 2021-12-21 | Almirall, S.A. | Results Almirall: Lebrikizumab demonstrated significant skin improvement and itch relief when combined with topical corticosteroids in people with atopic dermatitis in third Phase 3 study almirall.com ↗ |
| 2021-12-21 | Eli Lilly and Company | Results Lilly's lebrikizumab demonstrated significant skin improvement and itch relief when combined with topical corticosteroids in people with atopic dermatitis in third Phase 3 study lilly.com ↗
Lebrikizumab, an IL-13 inhibitor, significantly improved disease severity when combined with topical corticosteroids (TCS) in people with moderate-to-severe atopic dermatitis (AD) in Eli Lilly and Company's (NYSE: LLY) third pivotal Phase 3 trial (ADhere). |
| 2021-08-16 | Almirall, S.A. | Results Lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis in two Phase 3 trials almirall.com ↗
In the top-line results from these two monotherapy studies, primary and all key secondary endpoints, including skin clearance and itch improvement, were met at Week 16. |
| 2021-08-16 | Eli Lilly and Company | Results Lilly's lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis in two Phase 3 trials lilly.com ↗
In the top-line results from these two studies of lebrikizumab as a monotherapy in AD, primary and all key secondary endpoints, including skin clearance and itch improvement, were met at Week 16. |
| 2020-06-12 | Eli Lilly and Company | Results Lilly and Dermira Present New Lebrikizumab Phase 2b Clinical Data Showing Patients with Atopic Dermatitis Had Clinically Meaningful Improvements in Itch, Sleep and Quality of Life lilly.com ↗ |
| 2016-02-29 | Hoffmann-La Roche | Results Roche provides update on two identical phase III studies of lebrikizumab in people with severe asthma roche.com ↗
LAVOLTA I met its primary endpoint, showing a significant reduction in the rate of asthma exacerbations in people with higher levels of serum periostin or blood eosinophils, both biomarkers of airway inflammation. |
| 2016-02-28 | Genentech, Inc. | Results Genentech Provides Update on Two Identical Phase III Studies of Lebrikizumab in People with Severe Asthma gene.com ↗
LAVOLTA I met its primary endpoint, showing a significant reduction in the rate of asthma exacerbations in people with higher levels of serum periostin or blood eosinophils, both biomarkers of airway inflammation. |
All press releases naming this drug 51 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lebrikizumab | “A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)” NCT06338995 ↗45“A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)” NCT06339008 ↗ |
| Known as | Ebglyss | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743035 ↗ |
| Known as | LEB | “Lebrikizumab (LEB), a high-affinity monoclonal antibody targeting interleukin (IL)-13” PMID 36630140 ↗ Feb 20231“lebrikizumab (LEB) 250 mg Q2W, Q4W, or placebo” PMID 42315763 ↗ Jun 2026 |
| Known as | Lebrikizumab-lbkz | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07856134 ↗ |
| Known as | LY3650150 | “A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/ LY3650150 in Adult Participants...” NCT06339008 ↗2“A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)” NCT06338995 ↗ “A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants” NCT04840901 ↗ |
| Known as | MILR1444A | “Drug: lebrikizumab (MILR1444A)” NCT00971035 ↗ |
| Known as | PRO-301444 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743035 ↗ |
| Known as | PRO-301444 RG-3637 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743035 ↗ |
| Known as | RO-5490255 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743035 ↗ |
| Known as | TNX-650 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00441818 ↗ |
| Action | Inhibit | “IL13 pathway inhibition” PMID 24131304 ↗ Jan 2014 |
| Modality | Monoclonal antibody | “an anti-IL13 monoclonal antibody” PMID 24131304 ↗ Jan 2014 |
| Route | Subcutaneous | “administered subcutaneously” PMID 24131304 ↗ Jan 2014 |
| Target | IL13 | “anti-IL13 monoclonal antibody” PMID 24131304 ↗ Jan 2014 |