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← All drugs Report issue

tralokinumab

Trade name: Adtralza

mAbapproved

Approved

Dec 27, 2021

Tralokinumab sold under the brand names Adtralza (EU/UK) and Adbry (US) among others, is a human monoclonal antibody used for the treatment of atopic dermatitis. Tralokinumab targets the cytokine interleukin 13. — Wikipedia

Clinical trial activity

38 trials · 22 clinical orgs · 1 marketing orgs

Phase 1
9
Phase 2
27
Phase 3
15
Phase 4
1

Earliest trial started Sep 29, 2006 (NCT00974675)

Timeline

2000s

  1. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2014

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Dec 27, 2021

    Leo Pharma — Earliest FDA Approval

  2. Dec 27, 2021

    Leo Pharma — Marketing Organization

  3. Dec 27, 2021

    Leo Pharma — NDA Secondary Org

  4. Dec 27, 2021

    Leo Pharma — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 27, 2021

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • cat-354
  • cat-354
  • tralokinumab
  • tralokinumab
  • tralokinumab

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07027527Phase 1Jun 4, 2025Apogee Therapeutics, Inc.
NCT06311682Phase 3Jun 10, 2024Leo Pharma
NCT06773455Phase 4Sep 11, 2023Leo Pharma, Windsor Dermatology
NCT05958407Phase 3Aug 28, 2023Leo Pharma
NCT05388760Phase 2Sep 7, 2022Leo Pharma
NCT05378698Phase 2/Phase 3 (Phase 3)Jun 30, 2022University of Zurich
NCT05194540Phase 3Jan 13, 2022Leo Pharma
NCT04674826Phase 1Feb 8, 2021Leo Pharma
NCT04587453Phase 3Oct 27, 2020Leo Pharma
NCT04556461Phase 2Sep 28, 2020Universitaetsklinikum Schleswig-Holstein, University of Kiel
NCT03761537Phase 3Dec 28, 2018Leo Pharma
NCT03587805Phase 3Sep 20, 2018Leo Pharma
NCT03562377Phase 2Jul 13, 2018Leo Pharma
NCT03556592Phase 1Jun 25, 2018Leo Pharma
NCT03526861Phase 3Jun 19, 2018Leo Pharma
NCT03363854Phase 3Feb 22, 2018Leo Pharma
NCT03160885Phase 3Jun 28, 2017Leo Pharma, Oregon Health and Science University
NCT03131648Phase 3May 30, 2017Leo Pharma, Ludwig Maximilians University
NCT02902809Phase 3Nov 11, 2016AstraZeneca, Yokohama City University
NCT02684097Phase 2Jan 1, 2016Icahn School of Medicine at Mount Sinai
Showing 20 of 38 trials
Page 1 / 2

Organizations

Research & Development (22)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Leo PharmaFor profit151442017
MedImmuneFor profit121022006
AstraZenecaFor profit8732010
Institute for Lung Health, United KingdomAcademic/Hospital2022014
Apogee Therapeutics, Inc.For profit1112025
Cambridge Antibody TechnologyFor profit1012008
CelerionFor profit1012014
Humanitas UniversityAcademic/Hospital1012012
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112016
Ludwig Maximilians UniversityAcademic/Hospital1012017
MannKind CorpFor profit1112008
McGill UniversityAcademic/Hospital1112014
Oregon Health and Science UniversityAcademic/Hospital1012017
Pharmaceutical Research Associates, Inc. (PRA)For profit1012008
Sponsor GmbHAcademic/Hospital1012011
Universitaetsklinikum Schleswig-HolsteinAcademic/Hospital1112020
University of KielAcademic/Hospital1012020
University of PennsylvaniaAcademic/Hospital1012014
University of WisconsinAcademic/Hospital1012015
University of ZurichAcademic/Hospital1112022
22 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
Leo PharmaFor profitMKTGDec 27, 2021
Leo PharmaFor profitNDA2Dec 27, 2021
Leo PharmaFor profitNDADec 27, 2021