Drugs / Mepolizumab
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 1 milestone | |||||
| Filed | Japan (PMDA) | Nucala | asthma | — | “The New Drug Application for Nucala was submitted to the MHLW in May 2015” gsk.com ↗ |
| Filed chronic asthma 2 milestones | |||||
| Filed | EU (EMA) | Nucala | chronic asthma | 2014-11-05 | “filed regulatory submissions in the USA and Europe for mepolizumab for approval as a maintenance treatment for patients with severe eosinophilic asthma.” gsk.com ↗ “The Marketing Authorisation Application for Nucala was submitted to the EMA in November 2014” gsk.com ↗ |
| Filed | US (FDA) | — | chronic asthma | 2014-11-05 | “filed regulatory submissions in the USA and Europe for mepolizumab for approval as a maintenance treatment for patients with severe eosinophilic asthma.” gsk.com ↗ |
| Filed chronic obstructive pulmonary disease 3 milestones | |||||
| Filed | EU (EMA) | Nucala | chronic obstructive pulmonary disease | 2025-03-24 | “the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala (mepolizumab)” gsk.com ↗ |
| Filed | US (FDA) | Nucala | chronic obstructive pulmonary disease | 2018-09-10 | “An sBLA has also been filed for the treatment in patients with chronic obstructive pulmonary disease” gsk.com ↗ |
| Rejected (CRL) | US (FDA) | — | chronic obstructive pulmonary disease | 2018-09-07 | “today received a complete response letter (CRL) from the US FDA regarding its application for mepolizumab” gsk.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (5) | US (FDA) | NUCALA | — | 2017-12-12 – 2025-05-22 | fda.gov ↗ |
| Approved | EU (EMA) | Nucala | — | 2015-12-01 | europa.eu ↗ |
| Approved | US (FDA) | NUCALA | — | 2015-11-04 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05895929 | Sep 2023 → Dec 2025 | chronic rhinosinusitis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 0 | NCT03494881 | Jul 2019 → Nov 2023 | chronic idiopathic urticaria | Mayo Clinic | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT04305678 | Feb 2023 | eosinophilic fasciitis | Mayo Clinic | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04183192 | Feb 2020 → Apr 2021 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT01471327 | Aug 2011 → Apr 2012 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00527566 | Sep 2007 → Aug 2009 | eosinophilic granulomatosis with polyangiitis | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT00266565 | Dec 2001 → Apr 2005 | eosinophilic esophagitis, eosinophilic gastroenteritis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 213 trials · 3 met primary · 4 missed | ||||||
| Phase 2 | NCT06572267 | Oct 2024 → Sep 2026 overdue | coronary artery disorder | Xijing Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05320939 | Apr 2023 → Apr 2024 | chronic obstructive pulmonary disease | Temple University | Unknown | No outcome recorded |
| Phase 2 | NCT04128371 | Jan 2021 → Oct 2022 | angioedema, eosinophil disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | Missed primary |
| Phase 2 | NCT03656380 | Mar 2019 → Jun 2022 | eosinophilic esophagitis | University of North Carolina, Chapel Hill | Completed | Missed primary |
| Phase 2 | NCT03292588 | Nov 2017 → Apr 2021 | asthma | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 2 | NCT03055195 | Mar → Dec 2017 | atopic eczema | GlaxoSmithKline | Terminated | Missed primary |
| Phase 2 | NCT02377427 | Aug 2015 → Dec 2016 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01366521 | Feb 2011 → Mar 2012 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01362244 | May 2009 → Dec 2014 | nasal cavity polyp | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00716651 | Jul 2008 → Jul 2010 | eosinophilic granulomatosis with polyangiitis | University Hospital Schleswig-Holstein | Completed | No outcome recorded |
| Phase 2 | NCT00358449 | Sep 2006 → Nov 2008 | eosinophilic esophagitis | GlaxoSmithKline | Completed | Missed primary |
| Phase 2 | NCT00274703 | Dec 2005 → Mar 2007 | eosinophilic esophagitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00292877 | Jan 2005 → Jun 2008 | asthma | St. Joseph's Healthcare Hamilton | Completed | Met primary |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT04075331 | Sep 2020 → Jun 2024 | chronic obstructive pulmonary disease, eosinophil disorder | University of Leicester | Completed | Missed primary |
| Phase 325 trials · 10 met primary · 1 missed | ||||||
| Phase 3 | NCT04965636 | Jul 2022 → Oct 2025 | hypereosinophilic syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT05030155 | May 2022 → Feb 2025 | eosinophilic granulomatosis with polyangiitis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT05138250 | May 2022 → May 2025 | chronic obstructive pulmonary disease | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 3 | NCT04607005 | Apr 2021 → Apr 2023 | nasal cavity polyp | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT04133909 | Oct 2019 → Aug 2024 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT03562195 | Aug 2018 → Sep 2022 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT03306043 | Nov 2017 → Dec 2019 | hypereosinophilic syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03085797 | May 2017 → Dec 2019 | nasal cavity polyp | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02836496 | Mar 2017 → Aug 2019 | hypereosinophilic syndrome | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT03021304 | Feb → Aug 2017 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02555371 | Jan 2016 → Jul 2019 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02594332 | Nov 2015 → May 2017 | asthma | Johannes Gutenberg University Mainz | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03298061 | Apr 2015 → Feb 2023 | eosinophilic granulomatosis with polyangiitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02281318 | Dec 2014 → Jun 2016 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02135692 | May 2014 → Oct 2017 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02105961 | Apr 2014 → Jan 2017 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT02105948 | Apr 2014 → Jan 2017 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT02020889 | Feb 2014 → Sep 2016 | eosinophilic granulomatosis with polyangiitis | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01842607 | May 2013 → Mar 2015 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01691521 | Oct 2012 → Jan 2014 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01691508 | Oct 2012 → Dec 2013 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01691859 | Sep 2012 → May 2017 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01520051 | Jan 2012 → Dec 2013 | asthma, viral infectious disease | Academic Medical Center - University of Amsterdam | Unknown | No outcome recorded |
| Phase 3 | NCT00097370 | Sep 2004 → Sep 2010 | hypereosinophilic syndrome | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT00086658 | Mar 2004 → May 2006 | hypereosinophilic syndrome | GlaxoSmithKline | Completed | Met primary |
| Phase 416 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07200336 | Oct 2025 → Oct 2029 expected | chronic rhinosinusitis | Eye & ENT Hospital of Fudan University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07814924 | Dec 2024 → Dec 2026 expected | chronic rhinosinusitis | Marqués de Valdecilla Research Institute (IDIVAL) | Recruiting | No outcome recorded |
| Phase 4 | NCT06107101 | Jun 2024 → Jan 2025 | chronic rhinosinusitis | St. Paul's Sinus Centre | Unknown | No outcome recorded |
| Phase 4 | NCT06041386 | Mar 2024 → Jan 2025 overdue | asthma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05902325 | Oct 2023 → Dec 2026 expected | chronic rhinosinusitis | University of Montreal Hospital Centre (CHUM) | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05923047 | Sep 2023 → Sep 2024 | chronic rhinosinusitis, nasal cavity polyp | Marqués de Valdecilla Research Institute (IDIVAL) | Unknown | No outcome recorded |
| Phase 4 | NCT05642806 | Jul 2023 → Dec 2024 | asthma, chronic rhinosinusitis | St. Paul's Sinus Centre | Unknown | No outcome recorded |
| Phase 4 | NCT05598814 | Apr 2023 → Aug 2024 overdue | asthma, chronic rhinosinusitis | Vibeke Backer | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05626777 | Mar 2023 → Mar 2026 overdue | asthma | Hospices Civils de Lyon | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04765722 | Dec 2021 → Nov 2024 | asthma, chronic bronchitis | McMaster University | Completed | Missed primary |
| Phase 4 | NCT04823585 | Aug 2021 → Jan 2025 | aspirin-induced respiratory disease, chronic rhinosinusitis | Helsinki University Central Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04276233 | Jun 2021 → Oct 2023 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT05001529 | Mar 2021 → Mar 2022 | asthma | Scarlata, Simone, M.D. | Unknown | No outcome recorded |
| Phase 4 | NCT04228588 | Jan 2020 → Jan 2021 | T2-high asthma | University of Sao Paulo General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04412044 | Sep 2016 → May 2018 | asthma | KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT02654145 | Mar 2016 → May 2017 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase not applicable3 trials · 1 met primary | ||||||
| — | NCT06501807 | Jul 2024 → Sep 2034 expected | chronic rhinosinusitis, nasal cavity polyp | University Hospital, Lille | Recruiting | No outcome recorded |
| — | NCT05189613 | Sep 2021 → Jun 2022 | asthma, bronchiectasis | Policlinico Universitario, Catania | Unknown | No outcome recorded |
| — | NCT00802438 | Jun 2008 → Mar 2013 | asthma | University of Wisconsin, Madison | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT00244686 | — | hypereosinophilic syndrome | GlaxoSmithKline | No longer available | No outcome recorded |
| Comparator or background therapy18 trials | ||||||
| Phase 0 | NCT05353179 Comparator | Jun → Oct 2022 | granulomatosis with polyangiitis, hemophagocytic syndrome | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05576454 Comparator | Sep 2022 → May 2023 | asthma | Bio-Thera Solutions | Completed | Met primary |
| Phase 2 | NCT01705795 Comparator | Feb 2013 → Jan 2017 | bullous pemphigoid | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 2 | NCT01000506 Comparator | Nov 2009 → Mar 2012 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2/3 | NCT05979051 Comparator | Nov 2023 → Dec 2028 expected | eosinophilic granulomatosis with polyangiitis | Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT05263934 Comparator | Jul 2022 → Sep 2026 overdue | eosinophilic granulomatosis with polyangiitis | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04718389 Comparator | Jan 2021 → Sep 2025 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04157348 Comparator | Oct 2019 → Aug 2023 overdue | eosinophilic granulomatosis with polyangiitis | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03099096 Background | May → Nov 2017 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03014674 Comparator | Jan → Aug 2017 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01463644 Comparator | Jan 2012 → Aug 2015 | bronchitis, chronic obstructive pulmonary disease | McMaster University | Completed | No outcome recorded |
| Phase 4 | NCT06824649 Comparator | Jun 2026 → Feb 2030 expected | chronic rhinosinusitis, nasal cavity polyp | Medical University of South Carolina | Recruiting | No outcome recorded |
| Phase 4 | NCT07343661 Comparator | Oct 2025 → Oct 2026 expected | asthma, eosinophilic granulomatosis with polyangiitis | Azienda Ospedaliero Universitaria di Cagliari | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07187583 Comparator | Jun 2025 → Mar 2028 expected | chronic rhinosinusitis | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT07268313 Comparator | Apr 2025 → Jun 2027 expected | nasal cavity polyp | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT05942222 Comparator | Apr 2023 → Apr 2026 overdue | asthma, chronic rhinosinusitis, eosinophil disorder | Rigshospitalet, Denmark | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03476109 Comparator | May 2019 → Dec 2023 | asthma | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Unknown | No outcome recorded |
| Phase 4 | NCT04585997 Comparator | Nov 2018 → Jun 2022 | asthma | University of Newcastle, Australia | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 62
| Date | Issuer | Release |
|---|---|---|
| 2026-02-06 | GlaxoSmithKline | Regulatory Nucala (mepolizumab) approved by the European Commission for the treatment of chronic obstructive pulmonary disease (COPD) gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the European Commission has approved Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), in adults as an add-on maintenance treatment for uncontrolled COPD characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). |
| 2026-01-05 | GlaxoSmithKline | Regulatory Nucala (mepolizumab) approved in China for use in adults with chronic obstructive pulmonary disease (COPD) gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as add-on maintenance treatment of adult patients with inadequately controlled COPD characterised by raised blood eosinophils. |
| 2025-12-12 | GlaxoSmithKline | Regulatory Nucala (mepolizumab) receives positive CHMP opinion for treatment of chronic obstructive pulmonary disease (COPD) gsk.com ↗ |
| 2025-05-22 | GlaxoSmithKline | Regulatory Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD) gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. |
| 2025-05-02 | GlaxoSmithKline | Results GSK continues to advance the future of respiratory medicine and patient care with new data at ATS gsk.com ↗
Additional analyses from the MATINEE trial expands body of evidence for the reduction of COPD exacerbations, emergency department visits and/or hospitalisations with mepolizumab |
| 2025-04-30 | GlaxoSmithKline | Results Nucala (mepolizumab) delivers clinically meaningful and statistically significant reduction in COPD exacerbations, with positive MATINEE trial results published in New England Journal of Medicine gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive results for Nucala (mepolizumab) in the treatment of chronic obstructive pulmonary disease (COPD), with the full results from the MATINEE phase III trial published in the New England Journal of Medicine. |
| 2025-03-24 | GlaxoSmithKline | Regulatory GSK’s application to expand use of Nucala (mepolizumab) for the treatment of COPD accepted for review by the European Medicines Agency gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. |
| 2025-02-20 | GlaxoSmithKline | Regulatory Nucala (mepolizumab) application for COPD accepted for review in China gsk.com ↗ |
| 2025-01-03 | GlaxoSmithKline | Regulatory GSK’s Nucala (mepolizumab) approved in China for treatment of adults with chronic rhinosinusitis with nasal polyps gsk.com ↗
Mepolizumab is the only anti-interleukin-5 approved in China for the treatment of adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) |
| 2024-12-09 | GlaxoSmithKline | Regulatory US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD gsk.com ↗ |
| 2024-10-28 | AstraZeneca | Results Fasenra approved in the EU for eosinophilic granulomatosis with polyangiitis astrazeneca.com ↗
In the trial, nearly 60% of Fasenra- treated patients achieved remission, which was comparable to mepolizumab-treated patients. |
| 2024-09-06 | GlaxoSmithKline | Results GSK announces positive results from phase III trial of Nucala (mepolizumab) in COPD gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive headline results of MATINEE, the phase III clinical trial evaluating Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) in adults with chronic obstructive pulmonary disease (COPD). |
| 2024-08-28 | GlaxoSmithKline | Regulatory GSK’s Nucala (mepolizumab) approved in Japan for treatment of adults with chronic rhinosinusitis with nasal polyps gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients, limited to those who are inadequately controlled with standard treatment. |
| 2024-01-10 | GlaxoSmithKline | Regulatory Nucala (mepolizumab) approved in China for use in severe asthma with an eosinophilic phenotype gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has approved Nucala (mepolizumab), as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. |
| 2023-09-11 | AstraZeneca | Results Fasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA) astrazeneca.com ↗
Positive high-level results from the MANDARA Phase III trial showed AstraZeneca’s Fasenra (benralizumab) met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab in patients with eosinophilic granulomatosis with polyangiitis (EGPA) who were receiving oral corticosteroids (OCS) with or without stable immunosuppressive therapy. |
| 2023-09-01 | GlaxoSmithKline | Regulatory GSK’s regulatory submission accepted for review by Japanese regulator for use of Nucala (mepolizumab) in adults with chronic rhinosinusitis with nasal polyps gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients. |
| 2023-03-14 | GlaxoSmithKline | Regulatory China National Medical Products Administration accepts regulatory submission for Nucala (mepolizumab) in severe eosinophilic asthma gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has accepted for review a new drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA). |
| 2021-11-17 | GlaxoSmithKline | Regulatory European Commission approves Nucala (mepolizumab) in three additional eosinophil-driven diseases gsk.com ↗
GlaxoSmithKline (GSK) plc today announced that the European Commission has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use in three additional eosinophil-driven diseases. |
| 2021-09-17 | GlaxoSmithKline | Regulatory GSK receives CHMP positive opinions recommending approval of Nucala (mepolizumab) in three additional eosinophil-driven diseases gsk.com ↗
GlaxoSmithKline (GSK) plc today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use in three eosinophil-driven diseases; hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA) and chronic rhinosinusitis with nasal polyps (CRSwNP). |
| 2021-07-29 | GlaxoSmithKline | Regulatory GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps gsk.com ↗
GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). |
| 2020-12-08 | GlaxoSmithKline | Regulatory FDA accepts GSK’s filing of Nucala (mepolizumab) for use in chronic rhinosinusitis with nasal polyps gsk.com ↗ |
| 2020-10-29 | GlaxoSmithKline | Regulatory GSK Nucala (mepolizumab) filings accepted by European Medicines Agency for three additional eosinophil-driven diseases gsk.com ↗ |
| 2020-09-25 | GlaxoSmithKline | Regulatory FDA approves Nucala as the first and only biologic treatment for Hypereosinophilic Syndrome (HES) gsk.com ↗
The approval makes Nucala the first and only targeted biologic treatment to be approved for patients with this eosinophil-driven disease in the US. |
| 2020-05-27 | GlaxoSmithKline | Regulatory FDA grants priority review of Nucala for patients with Hypereosinophilic Syndrome (HES) gsk.com ↗
GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has granted a priority review for the company’s application seeking approval of Nucala (mepolizumab) in the treatment of patients with Hypereosinophilic Syndrome (HES) in the US. |
| 2020-04-03 | GlaxoSmithKline | Results Nucala (mepolizumab) is the first anti-IL5 biologic to report positive phase 3 results in patients with nasal polyps gsk.com ↗ |
| 2019-11-13 | GlaxoSmithKline | Results Nucala (mepolizumab) is the first treatment to show a significant reduction in flares for patients with Hypereosinophilic Syndrome (HES) gsk.com ↗
GlaxoSmithKline plc (GSK) today announced positive results from the pivotal study of Nucala (mepolizumab) in the treatment of patients living with Hypereosinophilic Syndrome (HES), making it the first treatment to demonstrate a reduction in flares for this rare disease. |
| 2019-09-30 | GlaxoSmithKline | Results Nucala significantly reduces exacerbations in first global prospective real-world study of a biologic in severe eosinophilic asthma gsk.com ↗
Results show a significant reduction in exacerbations and oral corticosteroid (OCS) use in patients after one year of treatment with Nucala when taken in a routine care setting, compared to the prior 12 months. |
| 2019-09-12 | GlaxoSmithKline | Regulatory Nucala is the first biologic approved in the US for six to 11-year-old children with severe eosinophilic asthma gsk.com ↗
Issued: London UK GlaxoSmithKline (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma. |
| 2019-08-01 | GlaxoSmithKline | Regulatory Nucala receives EU approval for self-administration by patients with severe eosinophilic asthma gsk.com ↗
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the European Commission has granted marketing authorisation for two new methods of administering Nucala (mepolizumab): a pre-filled pen and a pre-filled safety syringe. |
| 2019-06-06 | GlaxoSmithKline | Regulatory Nucala (mepolizumab) gains FDA approval for two new self-administration options gsk.com ↗
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate. |
| 2019-06-04 | GlaxoSmithKline | Regulatory Nucala (mepolizumab) receives positive CHMP opinion for new self-administration options gsk.com ↗ |
| 2018-11-19 | GlaxoSmithKline | Regulatory GSK submits US regulatory filing to expand the use of Nucala in children with severe eosinophilic asthma gsk.com ↗ |
| 2018-11-19 | PharmaLundensis AB | Results Problem för konkurrenters nya KOL-behandlingar pharmalundensis.se ↗
Substansen uppvisade ingen statistisk förbättring av lungfunktionen och ingen reduktion av hosta-slem. |
| 2018-09-10 | GlaxoSmithKline | Results GSK announces results of indirect treatment comparisons of Nucala to benralizumab and reslizumab for severe eosinophilic asthma gsk.com ↗
The data, published today in The Journal of Allergy and Clinical Immunology (JACI), showed that in patients with similar blood eosinophil counts, mepolizumab significantly reduced clinically significant exacerbations and improved asthma control compared with both benralizumab and reslizumab. |
| 2018-09-07 | GlaxoSmithKline | Regulatory GSK receives complete response letter from US FDA for use of mepolizumab in COPD patients gsk.com ↗
The CRL states that more clinical data are required to support an approval. |
| 2018-08-30 | GlaxoSmithKline | Regulatory European Commission approves Nucala (mepolizumab) for the treatment of children with severe asthma gsk.com ↗
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the European Commission has granted marketing authorisation for Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years. |
| 2018-07-27 | GlaxoSmithKline | Regulatory CHMP recommend Nucala (mepolizumab) for the treatment of severe eosinophilic asthma paediatric patients in Europe gsk.com ↗
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission. |
| 2018-07-25 | GlaxoSmithKline | Regulatory GSK reports on outcome of the FDA Advisory Committee on mepolizumab for the treatment of COPD patients on maximum inhaled therapy gsk.com ↗
The committee voted on the basis of data presented that the risk-benefit profile was not adequate to support approval (3 for, 16 against). |
| 2018-05-21 | GlaxoSmithKline | Results Nucala (mepolizumab) study reports long-term safety data, consistent exacerbation reduction and improved asthma control gsk.com ↗
The study showed consistent reductions in exacerbations and improvements in asthma control, with a safety profile similar to previous clinical studies, in severe eosinophilic asthma patients treated with Nucala (mepolizumab) over the long-term study period. |
| 2018-03-05 | GlaxoSmithKline | Results Nucala (mepolizumab) improved asthma control in patients uncontrolled on Xolair (omalizumab) gsk.com ↗
The results showed that severe asthma patients who are uncontrolled despite receiving Xolair (omalizumab) and who are eligible for treatment with Nucala (mepolizumab), experience improved asthma control when switched on to mepolizumab. |
| 2017-12-12 | GlaxoSmithKline | Regulatory GSK achieves approval for Nucala (mepolizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) for adults in the US gsk.com ↗
Issued: London UK GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome. |
| 2017-11-07 | GlaxoSmithKline | Regulatory GSK submits US regulatory application for mepolizumab in eosinophilic chronic obstructive pulmonary disease (COPD) gsk.com ↗
The submission to the FDA is the first to a regulatory authority for mepolizumab for COPD. |
| 2017-09-12 | GlaxoSmithKline | Results GSK announces phase III results published in NEJM of mepolizumab in patients with eosinophilic COPD at risk of exacerbations gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the publication of full results from the phase III studies for mepolizumab in chronic obstructive pulmonary disease (COPD). |
| 2017-06-28 | GlaxoSmithKline | Regulatory GSK announces US regulatory submission for mepolizumab in Eosinophilic Granulomatosis with Polyangiitis (EGPA) gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the submission of a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA), seeking approval of mepolizumab, an interleukin-5 (IL-5) antagonist, as an add-on therapy to corticosteroids for the treatment of adult patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA). |
| 2017-05-22 | GlaxoSmithKline | Results GSK presents data at ATS on treatment effect of Nucala (mepolizumab) in severe asthma according to blood eosinophil level gsk.com ↗
The data also showed an association between increasing lung function improvement and increasing eosinophil levels. |
| 2017-05-17 | GlaxoSmithKline | Results GSK announces NEJM publication of positive phase III study investigating mepolizumab in patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA) gsk.com ↗
In the 52-week pivotal phase III study, mepolizumab treatment demonstrated efficacy based on both co-primary efficacy endpoints and all secondary endpoints. |
| 2017-05-10 | GlaxoSmithKline | Results GSK announces headline phase III results of mepolizumab in patients with severe chronic obstructive pulmonary disease gsk.com ↗
In the group with higher eosinophils, there was a statistically significant reduction in the frequency of moderate and severe exacerbations for mepolizumab 100mg compared to placebo (18%, p=0.036 after multiplicity adjustment). |
| 2017-03-06 | GlaxoSmithKline | Results GSK’s MUSCA study shows Nucala® (mepolizumab) significantly improves quality of life and lung function in severe asthma patients with an eosinophilic phenotype gsk.com ↗
Lung function (first secondary endpoint), as measured by pre-bronchodilator FEV1, increased by 120mL (p=0.001) more than in placebo patients at week 24 – a clinically relevant and statistically significant improvement. |
| 2016-11-23 | GlaxoSmithKline | Results GSK announces phase lll study of mepolizumab meets co-primary endpoints and all secondary endpoints in patients with eosinophilic granulomatosis with polyangiitis gsk.com ↗ |
| 2016-10-07 | GlaxoSmithKline | Results New data published for GSK’s Nucala investigating hospitalisation reduction in severe asthma patients with an eosinophilic phenotype gsk.com ↗ |
| 2016-03-29 | GlaxoSmithKline | Regulatory GSK receives marketing authorisation for Nucala® (mepolizumab) in Japan gsk.com ↗
today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala® (mepolizumab) as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately controlled with standard treatment. |
| 2016-03-07 | GlaxoSmithKline | Results GSK presents data at AAAAI on efficacy of Nucala® (mepolizumab) in severe asthma patients stratified by eosinophil levels gsk.com ↗
Overall, the meta-analysis demonstrated a 47% (95% confidence interval: 38, 56) reduction in annual exacerbation rates with mepolizumab versus placebo. |
| 2016-03-05 | GlaxoSmithKline | Results GSK presents new data on the long-term efficacy & safety of Nucala® for the treatment of severe asthma with an eosinophilic phenotype gsk.com ↗ |
| 2015-12-02 | GlaxoSmithKline | Regulatory GSK receives European marketing authorisation for Nucala® (mepolizumab) in 31 countries gsk.com ↗
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the European Commission has granted marketing authorisation for Nucala® (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in adult patients. |
| 2015-11-04 | GlaxoSmithKline | Regulatory GSK’s Nucala® (mepolizumab) receives approval from US FDA gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today received approval from the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Nucala® (mepolizumab) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. |
| 2015-09-24 | GlaxoSmithKline | Regulatory GSK receives positive CHMP opinion in Europe for novel anti-IL5 biological Nucala (mepolizumab) for the treatment of patients with severe refractory eosinophilic asthma gsk.com ↗
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for mepolizumab, which will be commercialised under the brand name Nucala, as an add-on treatment for severe refractory eosinophilic asthma in adult patients. |
| 2015-06-11 | GlaxoSmithKline | Regulatory GSK announces outcome of US FDA Advisory Committee recommending approval of mepolizumab for the treatment of adults with severe asthma gsk.com ↗
The Committee also voted that the efficacy data provided substantial evidence of a clinically meaningful benefit in this population (14 yes, 0 no) and safety in adults with severe asthma had been adequately demonstrated (13 yes, 1 no). |
| 2015-05-22 | GlaxoSmithKline | Regulatory GSK submits Japan regulatory application for mepolizumab in severe eosinophilic asthma gsk.com ↗ |
| 2014-11-05 | GlaxoSmithKline | Regulatory GSK announces regulatory submissions for mepolizumab in severe eosinophilic asthma gsk.com ↗
A Biologics Licence Application to the US Food and Drug Administrationas an add-on maintenance treatment for severe eosinophilic asthma in patients aged 12 years and older with a history of exacerbations. |
| 2014-09-08 | GlaxoSmithKline | Results New England Journal of Medicine and ERS publish positive results from GSK phase III studies of mepolizumab in patients with severe eosinophilic asthma gsk.com ↗
Treatment with mepolizumab also enabled patients in the studies to experience improved quality of life and improved asthma control as set out further below. |
| 2014-03-12 | GlaxoSmithKline | Results GSK announces positive results from phase III studies for mepolizumab in severe eosinophilic asthma gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that a pivotal phase III study of mepolizumab, an investigational IL-5 antagonist monoclonal antibody, met its primary endpoint of reduction in the frequency of exacerbations, in patients with severe eosinophilic asthma. |
| 2009-07-28 | GlaxoSmithKline | Regulatory Regulatory update: mepolizumab for the treatment of hypereosinophilic syndrome (HES) gsk.com ↗
GSK today announced that it has notified the European Medicines Agency of its decision to withdraw the Marketing Authorisation Application (MAA) in the EU for mepolizumab for the treatment of hypereosinophilic syndrome (HES). |
All press releases naming this drug 66 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 87 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mepolizumab | “Subjects with severe uncontrolled asthma will be assigned to treatment with Omalizumab (anti Ig E antibodies) or Mepolizumab (anti IL-5 antibodies) according to medical advice...” NCT05001529 ↗79“Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab.” NCT06824649 ↗ “SB-240563 (mepolizumab) is a humanized monoclonal antibody that blocks human interleukin 5 (hIL-5) from binding to its receptor.” NCT01471327 ↗ “receiving mepolizumab (100 mg) or dupilumab (300 mg) every 4 weeks” NCT07187583 ↗ |
| Known as | Bosatria | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108429 ↗ |
| Known as | MEPO | “who received mepolizumab (MEPO) for the treatment of severe EA.” PMID 32994855 ↗ Sep 2020 |
| Known as | Mepolizumab, SB240563 | “Mepolizumab, SB240563” NCT01520051 ↗ |
| Known as | NUCALA | “This is a prospective, real-world, single arm, global, multi-centre study to evaluate the effect of timely treatment with mepolizumab (NUCALA) to achieve clinical remission in...” NCT06041386 ↗7“All subjects enrolled in this study were randomly assigned to receive BAT2606 or mepolizumab (European-sourced Nucala [Nucala-EU] and US-sourced Nucala [Nucala-US]) at a 1:1:1 ratio.” PMID 40786037 ↗ Jul 2025 “Mepolizumab 100 MG Injection [Nucala]” NCT07343661 ↗ “Mepolizumab Injection [Nucala]” NCT04412044 ↗ “Mepolizumab 100 MG [Nucala]” NCT04228588 ↗ |
| Known as | SB-240563 | “Mepolizumab (SB-240563) is a humanized monoclonal antibody (Immunoglobulin G1, kappa, mAb) that blocks human interleukin-5 (hIL-5) from binding to the interleukin (IL)-5...” NCT03014674 ↗6“Mepolizumab (SB-240563) is a humanized monoclonal antibody that blocks human interleukin 5 (IL-5) from binding to its receptor.” NCT01366521 ↗ “Intravenous Mepolizumab (SB240563)(0.55mg/kg, 2.5mg/kg or 10mg/kg) in Pediatric Subjects With Eosinophilic Esophagitis” NCT00358449 ↗ “Mepolizumab (SB240563) is an Immunoglobulin G 1 \[IgG1\], kappa humanized monoclonal antibody” NCT03085797 ↗ “mepolizumab (SB-240563) in reducing the need for surgery” NCT01362244 ↗ |
| Action | Inhibit | “Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity.” NCT00086658 ↗ |
| Modality | Monoclonal antibody | “Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity.” NCT00086658 ↗ |
| Route | Intravenous | “750 mg intravenously” NCT00086658 ↗ |
| Target | IL5 | “Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity.” NCT00086658 ↗ |