Drugs / Mepolizumab
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 ↗ |
Trials 65 · started per year
today
US approved 2015
EU approved 2015
1
2
2
1
1
2
1
2
4
1
5
3
3
6
1
3
3
7
3
8
4
1
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
| 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| Phase 1 | NCT04305678 | Feb 2023 | eosinophilic fasciitis | Mayo Clinic | Withdrawn | No outcome recorded |
| 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 | ||||||
| Phase 2 | NCT06572267 | Oct 2024 → Sep 2026 expected | 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 | No outcome recorded |
| Phase 2 | NCT03656380 | Mar 2019 → Jun 2022 | eosinophilic esophagitis | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT03292588 | Nov 2017 → Apr 2021 | asthma | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT03055195 | Mar → Dec 2017 | atopic eczema | GlaxoSmithKline | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04075331 | Sep 2020 → Jun 2024 | chronic obstructive pulmonary disease, eosinophil disorder | University of Leicester | Completed | No outcome recorded |
| Phase 325 trials | ||||||
| Phase 3 | NCT04965636 | Jul 2022 → Oct 2025 | hypereosinophilic syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT05030155 | May 2022 → Nov 2025 overdue | eosinophilic granulomatosis with polyangiitis | Assistance Publique - Hôpitaux de Paris | Active not recruiting | 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 | No outcome recorded |
| Phase 3 | NCT04133909 | Oct 2019 → Aug 2024 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03562195 | Aug 2018 → Sep 2022 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02836496 | Mar 2017 → Aug 2019 | hypereosinophilic syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03021304 | Feb → Aug 2017 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02555371 | Jan 2016 → Jul 2019 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02594332 | Nov 2015 → May 2017 | asthma | Johannes Gutenberg University Mainz | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02105948 | Apr 2014 → Jan 2017 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02020889 | Feb 2014 → Sep 2016 | eosinophilic granulomatosis with polyangiitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01842607 | May 2013 → Mar 2015 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01691521 | Oct 2012 → Jan 2014 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01691508 | Oct 2012 → Dec 2013 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT07200336 | Oct 2025 → Oct 2029 expected | chronic rhinosinusitis | Eye & ENT Hospital of Fudan University | Not yet 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) | 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | 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 | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00244686 | — | hypereosinophilic syndrome | GlaxoSmithKline | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 18 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05353179 Comparator | Jun → Oct 2022 | granulomatosis with polyangiitis, hemophagocytic syndrome | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT05576454 Comparator | Sep 2022 → May 2023 | asthma | Bio-Thera Solutions | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| 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 2/31 trial | ||||||
| Phase 2/3 | NCT05979051 Comparator | Nov 2023 → Dec 2028 expected | eosinophilic granulomatosis with polyangiitis | Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05263934 Comparator | Jul 2022 → Sep 2026 expected | 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 47 trials | ||||||
| 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 |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 86 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 ↗78“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 | SB240563 | “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 ↗ |