Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 2 | NCT02054130 | Dec 2013 → Dec 2016 | asthma | MedImmune LLC | Completed | Met 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 3 | NCT05583227 | Nov 2022 → Jul 2026 overdue | eosinophilic esophagitis | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT05398263 | Aug 2022 → Mar 2025 | asthma | AstraZeneca | Terminated | Met primary Stop: Enrollment |
| 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 | Met primary |
| Phase 3 | NCT03927157 | Jun 2019 → May 2024 | asthma | AstraZeneca | Completed | Met primary |
| 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 | Missed primary |
| Phase 3 | NCT03347279 | Nov 2017 → Sep 2020 | asthma | AstraZeneca | Completed | Met primary |
| 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
| Date | Issuer | Release |
|---|---|---|
| 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). |
| 2023-08-29 | AstraZeneca | Results AstraZeneca data at ERS 2023 demonstrate leadership in transforming care across a broad respiratory portfolio of inhaled and biologic medicines astrazeneca.com ↗ |
| 2023-02-02 | AstraZeneca | Regulatory Tezspire approved for self-administration in the US with a new pre-filled pen astrazeneca.com ↗
AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. |
| 2023-02-02 | Amgen | Regulatory TEZSPIRE® APPROVED FOR SELF-ADMINISTRATION IN THE U.S. WITH A NEW PRE-FILLED PEN amgen.com ↗
Amgen (NASDAQ:AMGN) and AstraZeneca today announced the U.S. Food and Drug Administration (FDA) has approved TEZSPIRE ® (tezepelumab-ekko) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. |
| 2023-01-13 | AstraZeneca | Regulatory Tezspire approved for self-administration in the EU in a new pre-filled pen astrazeneca.com ↗
AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. |
| 2022-09-27 | AstraZeneca | Regulatory Tezspire approved in Japan for the treatment of severe asthma astrazeneca.com ↗
AstraZeneca’s Tezspire (tezepelumab) has been approved in Japan for the treatment of bronchial asthma in patients with severe or refractory disease in whom asthma symptoms cannot be controlled with mid- or high-dose inhaled corticosteroids and other long-term maintenance therapies. |
| 2022-09-21 | AstraZeneca | Regulatory Tezspire approved in the EU for the treatment of severe asthma astrazeneca.com ↗
AstraZeneca’s Tezspire (tezepelumab) has been approved in the European Union (EU) as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product. |
| 2022-07-25 | AstraZeneca | Regulatory Tezspire recommended for approval in the EU by CHMP for the treatment of severe asthma astrazeneca.com ↗ |
| 2022-02-26 | Amgen | Results NEW DATA FURTHER REINFORCE EFFICACY OF TEZSPIRE™ (TEZEPELUMAB-EKKO) IN A BROAD POPULATION OF SEVERE ASTHMA PATIENTS amgen.com ↗
Amgen (NASDAQ:AMGN) today announced results from a pooled post-hoc analysis of the pivotal NAVIGATOR Phase 3 and PATHWAY Phase 2b trials showed TEZSPIRE™ (tezepelumab-ekko) demonstrated reductions in the annualized asthma exacerbation rate (AAER) across biomarker subgroups of patients with severe asthma. |
| 2021-12-17 | AstraZeneca | Regulatory Tezspire (tezepelumab) approved in the US for severe asthma astrazeneca.com ↗
AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma. |
| 2021-12-17 | Amgen | Regulatory FDA APPROVES TEZSPIRE™ (TEZEPELUMAB-EKKO) IN THE U.S. FOR SEVERE ASTHMA amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Amgen and AstraZeneca's Tezspire ™ (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. |
| 2021-10-08 | AstraZeneca | Regulatory Tezepelumab granted Orphan Drug Designation in the US for eosinophilic esophagitis astrazeneca.com ↗
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). |
| 2021-09-05 | Amgen | Results New Tezepelumab Data Show 86% Reduction In Exacerbations In Patients With Severe Asthma And Comorbid Nasal Polyps amgen.com ↗
Amgen (NASDAQ:AMGN) today announced new data from the pivotal NAVIGATOR Phase 3 trial demonstrating that tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with severe, uncontrolled asthma and comorbid nasal polyps. |
| 2021-07-08 | AstraZeneca | Regulatory Tezepelumab regulatory submission accepted and granted FDA Priority Review in the US for the treatment of patients with asthma astrazeneca.com ↗
AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). |
| 2021-07-08 | Amgen | Regulatory Tezepelumab Granted Priority Review By U.S. FDA amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. |
| 2021-05-13 | Amgen | Results New Tezepelumab Data Continue To Strengthen Profile For A Broad Population Of Severe Asthma Patients amgen.com ↗
In patients with elevated baseline blood eosinophil counts (≥300 cells per microlitre) and FeNO levels (≥25 parts per billion), tezepelumab achieved a clinically meaningful 77% reduction in the AAER, compared to placebo. |
| 2021-05-10 | Amgen | Regulatory Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA amgen.com ↗
Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) 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. |
| 2021-02-26 | AstraZeneca | Results Tezepelumab is the first biologic to consistently and significantly reduce exacerbations in broad population of severe asthma patients astrazeneca.com ↗
Tezepelumab, a potential first-in-class medicine, when added to standard of care (SoC) achieved a 56% reduction (p<0.001) in AAER over 52 weeks in the overall patient population, compared to placebo when added to SoC. |
| 2021-02-26 | Amgen | Results Tezepelumab Is The First Biologic To Significantly Reduce Exacerbations In Broad Population Of Patients With Severe, Uncontrolled Asthma amgen.com ↗
Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive full results from the pivotal NAVIGATOR Phase 3 trial, which showed the potential of tezepelumab to be a first-in-class medicine in severe asthma. |
| 2020-12-22 | AstraZeneca | Results Update on SOURCE Phase III trial for tezepelumab in patients with severe, oral corticosteroid-dependent asthma astrazeneca.com ↗
The 48-week trial did not meet the primary endpoint of a statistically significant reduction in the daily OCS dose, without loss of asthma control, with tezepelumab compared to placebo. |
| 2020-12-22 | Amgen | Results Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma amgen.com ↗
Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. |
| 2020-11-10 | AstraZeneca | Results Tezepelumab NAVIGATOR Phase III trial met primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations in a broad population of patients with severe asthma astrazeneca.com ↗
AstraZeneca and Amgen today announced positive results from the NAVIGATOR Phase III trial for the potential new medicine tezepelumab in patients with severe, uncontrolled asthma. |
| 2020-11-10 | Amgen | Results 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 ↗
Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive topline results from the Phase 3 NAVIGATOR trial in which the investigational medicine tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma. |
| 2018-09-07 | AstraZeneca | Regulatory Tezepelumab granted Breakthrough Therapy Designation by US FDA astrazeneca.com ↗
AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers. |
| 2018-09-06 | Amgen | Regulatory Tezepelumab Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Severe Asthma Without An Eosinophilic Phenotype amgen.com ↗
Amgen (NASDAQ: AMGN) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration ( FDA ) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype. |
| 2017-09-06 | AstraZeneca | Results Tezepelumab significantly reduced asthma exacerbations for a broad population of patients with severe uncontrolled asthma astrazeneca.com ↗
AstraZeneca and Amgen Inc. (Amgen) announce results from the PATHWAY Phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. |
| 2017-09-06 | Amgen | Results Tezepelumab Significantly Reduced Asthma Exacerbations For A Broad Population Of Patients With Severe Uncontrolled Asthma amgen.com ↗
Amgen (NASDAQ:AMGN) and AstraZeneca (NYSE:AZN) today announced results from the PATHWAY Phase 2b trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. |
| 2014-09-08 | AstraZeneca | Results Benralizumab Phase II COPD study published in The Lancet Respiratory Medicine astrazeneca.com ↗ |
All press releases naming this drug 40 releases
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 ↗ |