Drugs / Tezepelumab

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed acute asthma 1 milestone
Filed US (FDA) — acute asthma 2021-05-10

“submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma” amgen.com ↗

Filed bronchiectasis and nasal polyposis 3 milestones
Filed China (NMPA) — bronchiectasis and nasal polyposis —

“Regulatory applications are currently under review in Europe , China , Japan and several other countries based on the WAYPOINT trial.” amgen.com ↗

“Regulatory applications are currently under review in the US, China, Japan and several other countries based on the WAYPOINT trial.” astrazeneca.com ↗

Filed Japan (PMDA) — bronchiectasis and nasal polyposis —

“Regulatory applications are currently under review in Europe , China , Japan and several other countries based on the WAYPOINT trial.” amgen.com ↗

“Regulatory applications are currently under review in the US, China, Japan and several other countries based on the WAYPOINT trial.” astrazeneca.com ↗

Filed US (FDA) — bronchiectasis and nasal polyposis —

“Regulatory applications are currently under review in the US, China, Japan and several other countries based on the WAYPOINT trial.” astrazeneca.com ↗

Approved Indication not stated 1 milestone
Approved EU (EMA) Tezspire — 2022-09-19 europa.eu ↗

Trials 43

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials · 1 met primary
Phase 1 NCT04673630 Feb 2021 → Sep 2022 asthma AstraZeneca Completed No outcome recorded
Phase 1 NCT04362410 May → Oct 2020 — AstraZeneca Completed No outcome recorded
Phase 1 NCT03989544 Jun → Dec 2019 asthma AstraZeneca Completed Met primary
Phase 1 NCT02512900 Sep 2015 → May 2016 asthma MedImmune LLC Completed No outcome recorded
Phase 1 NCT01913028 Aug 2013 → Jan 2014 — AstraZeneca Completed No outcome recorded
Phase 1 NCT01405963 Oct 2011 → Apr 2013 asthma Amgen Completed Mixed
Phase 1 NCT00972179 Sep 2009 → Jan 2011 — Amgen Completed No outcome recorded
Phase 1 NCT00757042 Sep 2008 → Jan 2011 atopic eczema Amgen Completed No outcome recorded
Phase 1/21 trial · 1 missed
Phase 1/2 NCT02237196 Mar 2015 → Mar 2019 — National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 211 trials · 1 met primary · 3 missed
Phase 2 NCT07015996 Jul 2026 → May 2029 expected food allergy National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 2 NCT06230354 May 2024 → Sep 2026 overdue eosinophilic granulomatosis with polyangiitis Imperial College London Active not recruiting No outcome recorded
Phase 2 NCT06189742 Jan 2024 → Dec 2026 expected allergic respiratory disease Dr. Anne Ellis Active not recruiting No outcome recorded
Phase 2 NCT05740748 Apr 2023 → Dec 2024 allergic asthma McMaster University Unknown No outcome recorded
Phase 2 NCT05507242 Oct 2022 → Dec 2025 overdue bronchitis, chronic obstructive pulmonary disease, immune system disorder, reactive airway disease Asger Sverrild Recruiting No outcome recorded
Phase 2 NCT04833855 Apr 2021 → Dec 2022 chronic urticaria Amgen Completed Missed primary
Phase 2 NCT03809663 Mar 2019 → May 2020 atopic eczema Amgen Terminated Missed primary
Phase 2 NCT03688074 Nov 2018 → Nov 2020 allergic respiratory disease, asthma, obstructive lung disease AstraZeneca Completed Mixed
Phase 2 NCT02698501 Aug 2016 → Aug 2019 asthma Celeste Porsbjerg Completed No outcome recorded
Phase 2 NCT02525094 Aug 2015 → May 2016 atopic eczema MedImmune LLC Completed Missed primary
Phase 321 trials · 5 met primary · 1 missed
Phase 3 NCT07520162 Apr 2026 → Mar 2028 expected chronic rhinosinusitis AstraZeneca Recruiting No outcome recorded
Phase 3 NCT07363642 Jan 2026 → Feb 2028 expected asthma AstraZeneca Recruiting No outcome recorded
Phase 3 NCT07302516 Dec 2025 → Dec 2028 expected asthma Qilu Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT06878261 Mar 2025 → Mar 2029 expected chronic obstructive pulmonary disease AstraZeneca Recruiting No outcome recorded
Phase 3 NCT06883305 Mar 2025 → Mar 2029 expected chronic obstructive pulmonary disease AstraZeneca Recruiting No outcome recorded
Phase 3 NCT06740045 Jan → Mar 2025 overdue asthma, chronic rhinosinusitis Dr. Andrew Thamboo, MD Not yet recruiting No outcome recorded
Phase 3 NCT06706817 Dec 2024 → Jan 2027 expected chronic rhinosinusitis AstraZeneca Active not recruiting No outcome recorded
Phase 3 NCT06473779 Sep 2024 → Jun 2027 expected asthma AstraZeneca Active not recruiting No outcome recorded
Phase 3 NCT06023589 Aug 2023 → May 2028 expected asthma AstraZeneca Recruiting No outcome recorded
Phase 3 NCT05651841 Mar 2023 → Jan 2026 asthma University Hospital, Montpellier Completed No outcome recorded
Phase 42 trials
Phase 4 NCT06705764 May → Nov 2026 expected asthma University of Alberta Recruiting No outcome recorded
Phase 4 NCT05329194 Apr 2022 → Oct 2025 asthma AstraZeneca Completed No outcome recorded
Comparator or background therapy5 trials
Phase 1 NCT07327697 Comparator Dec 2025 → Jul 2026 overdue — Qilu Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT04039113 Comparator Jul 2019 → Nov 2023 chronic obstructive pulmonary disease AstraZeneca Completed No outcome recorded
Phase 3 NCT07013123 Background Jul 2025 → Aug 2029 expected asthma, house allergic alveolitis University Hospital, Montpellier Not yet recruiting No outcome recorded
Phase 3 NCT05280418 Comparator Nov 2022 → Nov 2025 asthma McMaster University Completed No outcome recorded
— NCT07046117 Comparator Oct 2025 → Jan 2028 expected asthma, chronic rhinosinusitis Medical University of Vienna Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 39

DateIssuerRelease
2026-08-27 Alexion Pharmaceuticals, Inc. Results Tezspire demonstrates positive Phase III results in eosinophilic esophagitis across both co-primary and all key secondary endpoints astrazeneca.com ↗
2026-08-27 Amgen Results TEZSPIRE® DEMONSTRATES POSITIVE PHASE 3 RESULTS IN EOSINOPHILIC ESOPHAGITIS ACROSS BOTH CO-PRIMARY AND ALL KEY SECONDARY ENDPOINTS amgen.com ↗
Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE ® (tezepelumab-ekko) in patients living with eosinophilic esophagitis (EoE).
2025-10-22 AstraZeneca Regulatory Tezspire approved in the EU for chronic rhinosinusitis with nasal polyps astrazeneca.com ↗
2025-10-17 AstraZeneca Regulatory Tezspire approved in the US for chronic rhinosinusitis with nasal polyps astrazeneca.com ↗
AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP), a complex epithelial-driven inflammatory condition.
2025-10-17 Amgen Regulatory FDA APPROVES TEZSPIRE® FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS amgen.com ↗
Amgen (NASDAQ:AMGN) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) approved TEZSPIRE ® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.
2025-09-22 AstraZeneca Regulatory Tezspire recommended for approval in the EU by CHMP for chronic rhinosinusitis with nasal polyps astrazeneca.com ↗
AstraZeneca and Amgen’s Tezspire (tezepelumab) has been recommended for approval in the European Union (EU) for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
2025-03-01 AstraZeneca Results Positive results from the Tezspire Phase III WAYPOINT trial highlight rapid and sustained effect in chronic rhinosinusitis with nasal polyps astrazeneca.com ↗
Importantly, Tezspire significantly reduced the need for subsequent nasal polyp surgery by 98% (p<0.0001) and the need for systemic corticosteroid treatment by 88% (p<0.0001) compared to placebo.
2025-03-01 Amgen Results POSITIVE RESULTS FROM TEZSPIRE® (TEZEPELUMAB-EKKO) PHASE 3 WAYPOINT TRIAL HIGHLIGHT RAPID, SUSTAINED EFFECT IN CHRONIC RHINOSINUSITIS WITH NASAL POLYPS amgen.com ↗
Amgen (NASDAQ:AMGN) and AstraZeneca today announced full results from the Phase 3, registrational WAYPOINT trial demonstrating that TEZSPIRE ® (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) compared to placebo.
2024-11-08 AstraZeneca Results Tezspire met both co-primary endpoints in the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps astrazeneca.com ↗
Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp size and reduced nasal congestion compared to placebo
2024-11-08 Amgen Results TEZSPIRE MET BOTH CO-PRIMARY ENDPOINTS IN PHASE 3 TRIAL FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS amgen.com ↗
The trial demonstrated patients treated with TEZSPIRE ® (tezepelumab-ekko) had a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.
2024-05-19 Amgen Results NEW DATA PRESENTED AT ATS 2024 SHOW THE POTENTIAL OF TEZSPIRE® TO HELP PATIENTS LIVING WITH COPD amgen.com ↗
The primary results showed that treatment with Tezspire led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant (90% CI: -6, 36; p[1-sided]=0.1042).
2024-04-16 Amgen Results AMGEN TO PRESENT TEZSPIRE® PHASE 2A COPD DATA AT ATS 2024 amgen.com ↗
Overall, tezepelumab numerically reduced the annualized rate of moderate or severe COPD exacerbations versus placebo by 17% (90% CI: −6, 36; p=0.1042).

All press releases naming this drug 40 releases

DateIssuerRelease

Evidence & citations 11 cited values

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

FieldValueCited text
Known as tezepelumab “This is a summary of the results of 2 clinical studies that looked at a medicine called tezepelumab.” PMID 37772607 ↗ Sep 2023
42

“Tezspire®(Tezepelumab)” NCT07327697 ↗

“Drug: Tezepelumab” NCT07363642 ↗

NCT04048343 ↗

NCT05329194 ↗

NCT03406078 ↗

NCT04362410 ↗

NCT06883305 ↗

NCT06230354 ↗

NCT05280418 ↗

NCT03809663 ↗

Show 32 more sources

Known as AMG 157 “The primary objective is to evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to...” NCT02512900 ↗
2

“Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma” NCT02054130 ↗

NCT02237196 ↗

Known as MEDI-19929 ChEMBL registry synonym — accepted as the source's own label CHEMBL3707229 ↗
Known as MEDI9929 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01913028 ↗
4

NCT02525094 ↗

NCT02054130 ↗

NCT02512900 ↗

NCT02698501 ↗

Known as MEDI9929/AMG 157 “MEDI9929/AMG 157” NCT02237196 ↗
Known as Tezepelumab ekko ChEMBL registry synonym — accepted as the source's own label CHEMBL3707229 ↗
Known as Tezspire ChEMBL registry synonym — accepted as the source's own label CHEMBL3707229 ↗
Action Inhibit “blocks the activity of thymic stromal lymphopoietin” PMID 41072729 ↗ Oct 2025
Modality Monoclonal antibody “Tezepelumab, a human monoclonal antibody, blocks the activity of thymic stromal lymphopoietin.” PMID 41072729 ↗ Oct 2025
Route Subcutaneous “subcutaneous (SC)” NCT00972179 ↗
Target TSLP “directed against TSLP” NCT02698501 ↗