lebrikizumab

mAbapprovedFast Track FDA

Approved

Sep 13, 2024

Lebrikizumab, sold under the brand name Ebglyss, is a humanized monoclonal antibody used for the treatment of atopic dermatitis. It is an interleukin-13 antagonist. It is given by subcutaneous injection. — Wikipedia

Clinical trial activity

45 trials · 9 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
38
Phase 3
25
Phase 4
2

Earliest trial started May 1, 2006 (NCT00441818)

Timeline

2000s

  1. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Sep 13, 2024

    Eli Lilly — Earliest FDA Approval

  2. Sep 13, 2024

    Eli Lilly — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedFast trackSep 13, 2024

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • lebrikizumab
  • lebrikizumab
  • lebrikizumab
  • milr1444a
  • pro-301444
  • pro-301444 rg-3637
  • rg-3637
  • tnx-650
  • tnx-650

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06906497Phase 4Jul 2, 2025Almirall, Dermira, Inc., University of Michigan
NCT07006792Phase 4Jun 16, 2025Eli Lilly
NCT06921759Phase 3Apr 21, 2025Eli Lilly
NCT06526182Phase 3Jul 3, 2024Almirall
NCT06444165Phase 3Jun 4, 2024Eli Lilly
NCT06338995Phase 3Apr 29, 2024Eli Lilly
NCT06339008Phase 3Apr 26, 2024Eli Lilly
NCT06280716Phase 3Apr 24, 2024Eli Lilly
NCT06243198Phase 1Mar 28, 2024Eli Lilly
NCT06119529Phase 1Nov 1, 2023Eli Lilly
NCT05990725Phase 3Oct 30, 2023Almirall
NCT05916365Phase 3May 23, 2023Almirall
NCT05735483Phase 3Mar 9, 2023Eli Lilly
NCT05369403Phase 3Dec 19, 2022Eli Lilly
NCT05372419Phase 3Dec 15, 2022Eli Lilly
NCT05559359Phase 3Oct 18, 2022Dermira, Inc., Eli Lilly
NCT05149313Phase 3Dec 31, 2021Almirall
NCT04840901Phase 1Jun 2, 2021Eli Lilly
NCT04760314Phase 3Mar 10, 2021Eli Lilly
NCT04626297Phase 3Nov 17, 2020Eli Lilly
Showing 20 of 45 trials
Page 1 / 3

Organizations

Research & Development (9)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Eli LillyFor profit161532020
RocheFor profit121132013
Dermira, Inc.For profit8632018
GenentechFor profit7722008
AlmirallFor profit5422021
Cornell UniversityAcademic/Hospital1012006
TanoxFor profit1112006
University of MichiganAcademic/Hospital1112025
University of Texas at HoustonAcademic/Hospital1012006
9 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
Eli LillyFor profitNDASep 13, 2024