Drugs / Lebrikizumab

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Ebglyss 2023-11-16 europa.eu

Trials 45 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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
Phase 2 NCT07620561 Jun 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 No outcome recorded
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 No outcome recorded
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 No outcome recorded
Phase 2 NCT01545440 Mar 2012 → Mar 2013 asthma Genentech, Inc. Completed No outcome recorded
Phase 2 NCT01545453 Mar 2012 → Jul 2013 asthma Genentech, Inc. Completed No outcome recorded
Phase 325 trials
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 No outcome recorded
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 expected perennial allergic rhinitis Eli Lilly and Company 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 43 trials
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 Recruiting No outcome recorded
Phase 4 NCT07006792 Jun 2025 → May 2026 overdue atopic eczema Eli Lilly and Company Active not recruiting No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07471932 Comparator Feb 2026 → May 2027 expected Almirall, S.A. Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT06444165 Background Jun 2024 atopic eczema Eli Lilly and Company Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2016-02-29 Roche Global Development Roche provides update on two identical phase III studies of lebrikizumab in people with severe asthma roche.com

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 51 sources stand behind the page.

FieldValueCited 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

NCT05990725

NCT00971035

NCT05372419

NCT02340234

NCT06444165

NCT02546700

NCT07620561

NCT04760314

NCT05149313

NCT02546869

NCT06526182

NCT05369403

NCT02099656

NCT05559359

NCT07471932

NCT04250350

NCT04146363

NCT06906497

NCT04178967

NCT07542483

NCT06243198

NCT01875003

NCT07352566

NCT06280716

NCT01987492

NCT00781443

NCT01872689

NCT06921759

NCT05916365

NCT05735483

NCT04840901

NCT04250337

NCT02465606

NCT02104674

NCT07006792

NCT01867125

NCT01545453

NCT03443024

NCT01545440

NCT01868061

NCT04392154

NCT04626297

NCT00930163

NCT01423318

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 2023
1

lebrikizumab (LEB) 250 mg Q2W, Q4W, or placebo” PMID 42315763 Jun 2026

Known as Lebrikizumab-lbkz ChEMBL registry synonym — accepted as the source's own label CHEMBL1743035
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
2

“lebrikizumab (MILR1444A)” NCT00781443

“lebrikizumab (MILR1444A)” NCT00930163

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 antibodyPMID 24131304 Jan 2014
Route Subcutaneous “administered subcutaneously” PMID 24131304 Jan 2014
Target IL13 “anti-IL13 monoclonal antibody” PMID 24131304 Jan 2014