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Drug

Mepolizumab

Approved · EMA
Late-stage development

Also known as Nucala.

RxNorm1720597UNII90Z2UF0E52
11
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy

Clinical trial2026-07-08Results expected Q3 2026 · ClinicalTrials.gov

A Phase 3, 52-week, Open-label, Single Arm Study to Investigate the Efficacy and Safety of Mepolizumab SC in Participants Aged 6 to 17 Years With Hypereosinophilic Syndrome

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab

Clinical trial2026-05-18Results posted · ClinicalTrials.gov

A Randomised, Double-blind, Active-controlled 52-week Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy (MANDARA Study)

Clinical trial2026-05-11Results posted · ClinicalTrials.gov

A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD

Clinical trial2026-05-07Results posted · ClinicalTrials.gov

A Randomised Controlled Trial of Mepolizumab Initiated Following Admission to Hospital for a Severe Exacerbation of Eosinophilic COPD

Clinical trial2026-04-24Results posted · ClinicalTrials.gov

Treatment of Rhinosinusitis With Nasal Polyposis With Dupilumab and Mepolizumab: A Randomized, Multi-centre, Head-to-head Comparison in Real-world Danish Patients

Clinical trial2026-04-01Primary completion · ClinicalTrials.gov

Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)

Clinical trial2026-03-24Results posted · ClinicalTrials.gov

The Role of IL5 in Epithelial Cell Integrity

Clinical trial2026-02-27Completed · ClinicalTrials.gov

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

Clinical trial2026-01-23Results expected Q3 2026 · ClinicalTrials.gov

Beyond Eosinophils: Proteomics to Identify Potential Biomarkers of Organ Damage and Response to MEPOLIZUMAB in EGPA

Clinical trial2026-01-15Results expected Q4 2026 · ClinicalTrials.gov

Approval: Nucala (EMA)

Regulatory2015-12-01EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mepolizumab
Aliases & brands
Nucala
RxNorm CUI
1720597
UNII
90Z2UF0E52
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2015-12-01
Latest approval
2015-12-01
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2015-12-01Approval
Approval: Nucala (EMA)
Indication: Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older . Chronic… Show full indication

Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older . Chronic rhinosinusitis with nasal polyps (CRSwNP)Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. Eosinophilic granulomatosis with polyangiitis (EGPA)Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Hypereosinophilic syndrome (HES)Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

68 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
68
registered trials across all phases
LATEST COMPLETION 2026
11
Active studies
5
Recruiting
48
Late-stage (III+)
44
Completed
13
Discontinued
PHASE DISTRIBUTIONn = 68
Early Phase 12Phase 13Phase 1 / 22Phase 213Phase 2 / 32Phase 329Phase 415Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy of Anti-IL-5 Therapy Combined With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery in Patients With CRSwNP: A Multicenter Randomized Controlled Trial

Not yet recruitingPH IVEye & ENT Hospital of Fudan Universityn=3602031

Beyond Eosinophils: Proteomics to Identify Potential Biomarkers of Organ Damage and Response to MEPOLIZUMAB in EGPA

Enrolling by invitationPH IVAzienda Ospedaliero Universitaria di Cagliarin=902028

A Prospective, Real-World, Interventional Study To Evaluate The Effect Of Mepolizumab On Achieving Clinical Remission In Participants With Severe Asthma

Active, not recruitingPH IVGlaxoSmithKlinen=3362028

Identifying Predictors Of Long-Lasting Response To Mepolizumab In CRSwNP: Is The Disease-Modifying Role Secondary To Restored Anti-Viral Activity Or Enhanced Epithelial Regeneration?

RecruitingPH IVCentre hospitalier de l'Université de Montréal (CHUM)n=362026

Treatment of Rhinosinusitis With Nasal Polyposis With Dupilumab and Mepolizumab: A Randomized, Multi-centre, Head-to-head Comparison in Real-world Danish Patients

Active, not recruitingPH IVRigshospitalet, Denmarkn=2202026

Recent completions

Trials that read out recently, adding to the completed evidence base.

The Role of IL5 in Epithelial Cell Integrity

CompletedPH IJohns Hopkins Universityn=172026

A Phase 3, 52-week, Open-label, Single Arm Study to Investigate the Efficacy and Safety of Mepolizumab SC in Participants Aged 6 to 17 Years With Hypereosinophilic Syndrome

CompletedPH IIIGlaxoSmithKlinen=162025

A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab

CompletedPH IIIKey trialGlaxoSmithKlinen=1,7172025

A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD

CompletedPH IIISheffield Teaching Hospitals NHS Foundation Trustn=312025

Mepolizumab for the Treatment of Chronic Spontaneous Urticaria: An Open-label, Single-arm, Exploratory Study

CompletedPH IMayo Clinicn=102025

Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)

CompletedPH IVHelsinki University Central Hospitaln=952025
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.