CDEK
← All drugs Report issue

tezepelumab

Trade name: Tezspire

mAbapproved

Approved

Dec 17, 2021

Tezepelumab, sold under the brand name Tezspire, is a human monoclonal antibody used for the treatment of asthma. Tezepelumab blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine that has been suggested to be critical in the initiation and persistence of airway inflammation. — Wikipedia

Clinical trial activity

45 trials · 38 clinical orgs · 1 marketing orgs

Phase 1
9
Phase 2
34
Phase 3
21
Phase 4
2

Earliest trial started Oct 1, 2008 (NCT00757042)

Timeline

2000s

  1. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2017

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

2020s

  1. Dec 17, 2021

    AstraZeneca — Earliest FDA Approval

  2. Dec 17, 2021

    AstraZeneca — Marketing Organization

  3. Dec 17, 2021

    AstraZeneca — NDA Secondary Org

  4. Dec 17, 2021

    AstraZeneca — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewDec 17, 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

  • amg 157
  • amg-157
  • medi9929
  • medi-9929

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07015996Phase 2Feb 18, 2026Immune Tolerance Network, National Institute of Allergy and Infectious Diseases (NIAID), PPD, Rho, Inc.
NCT07302516Phase 3Dec 25, 2025Qilu Pharmaceutical Co., Ltd.
NCT07046117N/AOct 1, 2025Medical University of Vienna
NCT07013123Phase 3Jul 15, 2025ALK-Abello, S.A., AstraZeneca, University of Montpellier, University of Nimes
NCT06878261Phase 3Mar 31, 2025Amgen, AstraZeneca
NCT06883305Phase 3Mar 18, 2025Amgen, AstraZeneca, University of Manchester
NCT06740045Phase 3Jan 31, 2025AstraZeneca, St. Paul's Sinus Centre, St Paul's Sonis Centre Director
NCT06705764Phase 4Nov 30, 2024AstraZeneca, University of Alberta
NCT06706817Phase 3Nov 29, 2024AstraZeneca, Fortrea
NCT06473779Phase 3Sep 30, 2024AstraZeneca, Fortrea
NCT06230354Phase 2May 31, 2024AstraZeneca, Imperial College London
NCT06189742Phase 2Jan 29, 2024Queen's University, Belfast
NCT06023589Phase 3Aug 24, 2023Amgen, AstraZeneca
NCT05740748Phase 2Apr 1, 2023McMaster University, University of Saskatchewan
NCT05651841Phase 3Jan 15, 2023University of Montpellier
NCT05583227Phase 3Nov 10, 2022Amgen, AstraZeneca
NCT05507242Phase 2Sep 1, 2022AstraZeneca, University of Antwerp, University of Copenhagen, University of Leicester
NCT05398263Phase 3Aug 9, 2022Amgen, AstraZeneca
NCT05280418Phase 3May 31, 2022McMaster University
NCT05274815Phase 3May 17, 2022AstraZeneca
Showing 20 of 45 trials
Page 1 / 3

Organizations

Research & Development (38)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit292342013
AmgenFor profit26532008
MedImmuneFor profit4322013
FortreaFor profit2012024
Immune Tolerance NetworkAcademic/Hospital2012014
McMaster UniversityAcademic/Hospital2222022
National Institute of Allergy and Infectious Diseases (NIAID)Government2212014
ParexelFor profit2022019
Royal Brompton Hospital, United KingdomAcademic/Hospital2012017
University of CopenhagenAcademic/Hospital2112016
University of LeicesterAcademic/Hospital2012018
University of ManchesterAcademic/Hospital2022019
University of MontpellierAcademic/Hospital2212023
ALK-Abello, S.A.For profit1012025
Clinical Research Trials of Florida, Inc.For profit1012019
Government of JapanGovernment1012019
Guangzhou Medical UniversityAcademic/Hospital1012019
Imperial College LondonAcademic/Hospital1112024
Kyushu Clinical Pharmacolgy Reasearch ClinicAcademic/Hospital1012013
Lund UniversityAcademic/Hospital1012016
38 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
AstraZenecaFor profitMKTGDec 17, 2021
AstraZenecaFor profitNDA2Dec 17, 2021
AstraZenecaFor profitNDADec 17, 2021