Drugs / Tezepelumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Tezspire | — | 2022-09-19 | europa.eu ↗ |
Trials 43 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | ||||||
| Phase 1/2 | NCT02237196 | Mar 2015 → Mar 2019 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 211 trials | ||||||
| Phase 2 | NCT07015996 | Jul 2026 → Sep 2028 expected | food allergy | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT06230354 | May 2024 → Sep 2026 expected | 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 | No outcome recorded |
| Phase 2 | NCT03809663 | Mar 2019 → May 2020 | atopic eczema | Amgen | Terminated | No outcome recorded |
| Phase 2 | NCT03688074 | Nov 2018 → Nov 2020 | allergic respiratory disease, asthma, obstructive lung disease | AstraZeneca | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT02054130 | Dec 2013 → Dec 2016 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 321 trials | ||||||
| Phase 3 | NCT07520162 | Apr 2026 → Mar 2028 expected | chronic rhinosinusitis | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT07363642 | Jan 2026 → Aug 2027 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 3 | NCT05583227 | Nov 2022 → Jul 2026 overdue | eosinophilic esophagitis | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05398263 | Aug 2022 → Mar 2025 | asthma | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT05274815 | May 2022 → Sep 2024 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT05062759 | Aug 2021 → Mar 2022 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT04851964 | Apr 2021 → Sep 2024 | chronic rhinosinusitis | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03927157 | Jun 2019 → May 2024 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT04048343 | Jun 2019 → Mar 2021 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03968978 | May 2019 → Jun 2020 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03706079 | Jan 2019 → Oct 2021 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03406078 | Mar 2018 → Sep 2020 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03347279 | Nov 2017 → Sep 2020 | asthma | AstraZeneca | 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 |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07327697 Comparator | Dec 2025 → Jul 2026 overdue | — | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04039113 Comparator | Jul 2019 → Nov 2023 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| 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 |
| Phase not applicable1 trial | ||||||
| — | NCT07046117 Comparator | Oct 2025 → Jan 2028 expected | asthma, chronic rhinosinusitis | Medical University of Vienna | Not yet recruiting | No outcome recorded |
Press releases naming this drug 23 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-10-22 | AstraZeneca | Tezspire approved in the EU for chronic rhinosinusitis with nasal polyps astrazeneca.com ↗ |
| 2025-10-17 | AstraZeneca | Tezspire approved in the US for chronic rhinosinusitis with nasal polyps astrazeneca.com ↗ |
| 2025-10-17 | Amgen | FDA APPROVES TEZSPIRE® FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS amgen.com ↗ |
| 2025-09-22 | AstraZeneca | Tezspire recommended for approval in the EU by CHMP for chronic rhinosinusitis with nasal polyps astrazeneca.com ↗ |
| 2025-03-01 | AstraZeneca | Positive results from the Tezspire Phase III WAYPOINT trial highlight rapid and sustained effect in chronic rhinosinusitis with nasal polyps astrazeneca.com ↗ |
| 2025-03-01 | Amgen | POSITIVE RESULTS FROM TEZSPIRE® (TEZEPELUMAB-EKKO) PHASE 3 WAYPOINT TRIAL HIGHLIGHT RAPID, SUSTAINED EFFECT IN CHRONIC RHINOSINUSITIS WITH NASAL POLYPS amgen.com ↗ |
| 2024-11-08 | AstraZeneca | Tezspire met both co-primary endpoints in the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps astrazeneca.com ↗ |
| 2024-11-08 | Amgen | TEZSPIRE MET BOTH CO-PRIMARY ENDPOINTS IN PHASE 3 TRIAL FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS amgen.com ↗ |
| 2024-05-19 | Amgen | NEW DATA PRESENTED AT ATS 2024 SHOW THE POTENTIAL OF TEZSPIRE® TO HELP PATIENTS LIVING WITH COPD amgen.com ↗ |
| 2024-04-16 | Amgen | AMGEN TO PRESENT TEZSPIRE® PHASE 2A COPD DATA AT ATS 2024 amgen.com ↗ |
| 2023-02-02 | Amgen | TEZSPIRE® APPROVED FOR SELF-ADMINISTRATION IN THE U.S. WITH A NEW PRE-FILLED PEN amgen.com ↗ |
| 2022-02-26 | Amgen | NEW DATA FURTHER REINFORCE EFFICACY OF TEZSPIRE™ (TEZEPELUMAB-EKKO) IN A BROAD POPULATION OF SEVERE ASTHMA PATIENTS amgen.com ↗ |
| 2022-01-13 | Amgen | TEZSPIRE™ (TEZEPELUMAB-EKKO) NOW AVAILABLE IN THE UNITED STATES FOR THE TREATMENT OF SEVERE ASTHMA amgen.com ↗ |
| 2021-12-17 | Amgen | FDA APPROVES TEZSPIRE™ (TEZEPELUMAB-EKKO) IN THE U.S. FOR SEVERE ASTHMA amgen.com ↗ |
| 2021-09-05 | Amgen | New Tezepelumab Data Show 86% Reduction In Exacerbations In Patients With Severe Asthma And Comorbid Nasal Polyps amgen.com ↗ |
| 2021-07-08 | Amgen | Tezepelumab Granted Priority Review By U.S. FDA amgen.com ↗ |
| 2021-05-13 | Amgen | New Tezepelumab Data Continue To Strengthen Profile For A Broad Population Of Severe Asthma Patients amgen.com ↗ |
| 2021-05-10 | Amgen | Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA amgen.com ↗ |
| 2021-02-26 | Amgen | Tezepelumab Is The First Biologic To Significantly Reduce Exacerbations In Broad Population Of Patients With Severe, Uncontrolled Asthma amgen.com ↗ |
| 2020-12-22 | Amgen | Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma amgen.com ↗ |
| 2020-11-10 | Amgen | Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma amgen.com ↗ |
| 2018-09-06 | Amgen | Tezepelumab Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Severe Asthma Without An Eosinophilic Phenotype amgen.com ↗ |
| 2017-09-06 | Amgen | Tezepelumab Significantly Reduced Asthma Exacerbations For A Broad Population Of Patients With Severe Uncontrolled Asthma amgen.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited 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 |
| 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 ↗ |
| 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 ↗ |
| 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 ↗ |