Nucala

(Mepolizumab)

ApprovedMonoclonal antibody

Mepolizumab is used to treat severe asthma and certain blood disorders where the body produces too many eosinophils (a type of white blood cell). It works by reducing the number of these cells to help control symptoms and prevent attacks.[2] Nucala is currently approved and in use across 12 indications[4].[1]

Nucala is one of 151 biologic programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

150

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseRecruiting

VasculitisUnknown

BronchiectasisActive, not recruiting

Airway ObstructionUnknown

Physical ActivityActive, not recruiting

Chronic RhinosinusitisRecruiting

Chronic Rhinosinusitis With Nasal PolypsRecruiting

Chronic CoughCompleted

CrswnpNot yet recruiting

Sinus SurgeryNot yet recruiting

Coronary Artery DiseasePhase 2

Recruiting

VasculitisPreclinical

Unknown

BronchiectasisPreclinical

Active, not recruiting

Airway ObstructionPreclinical

Unknown

Physical ActivityPreclinical

Active, not recruiting

Chronic RhinosinusitisApproved

Recruiting

Chronic Rhinosinusitis With Nasal PolypsApproved

Recruiting

Chronic CoughApproved

Completed

CrswnpApproved

Not yet recruiting

Sinus SurgeryApproved

Not yet recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

117 competitors in Coronary Artery Disease

#DrugCompanyPhaseTrials

Brilinta

AstraZeneca

Approved

13 2

Niacor

AbbVie

Approved

2 3

Victoza

Novo Nordisk

Approved

2 4

Lovenox

Sanofi

Approved

1 5

Zebeta

Teva

Approved

1 6

Inomax

MMallinckrodt

Approved

2 7

Jardiance

Boehringer Ingelheim

Approved

2 8

Nucala

GGlaxo Dba Glaxosmithkline

Approved

1 9

Zocor

OOrganon and Co

Approved

1 10

Colcrys

Jazz Pharmaceuticals

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Eosinophilic Granulomatous Vasculitis

NCT04157348

Recruiting

Chronic Rhinosinusitis

NCT06683261

ApprovedRecruiting

Chronic Rhinosinusitis With Nasal Polyps

NCT07814924

ApprovedActive, not recruiting

Chronic Rhinosinusitis With Nasal Polyps

NCT05902325

Q1 2027

Phase 2Recruiting

Coronary Artery Disease

NCT06572267

Recruiting

Asthma

NCT05708300

Clinical

Trials by Indication[1]

Asthma34 trials

Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control

Completed· GSK logo

GSK·Phase 3·NCT02281318·556 enrolled

Mepolizumab Treatment for Rhinovirus-induced Asthma Exacerbations

Unknown status·—·Phase 3·NCT01520051·48 enrolled

Impulse Oscillometry Measurements in Severe Eosinophilic Asthmatics Before and After Anti-IL-5 Factor Initiation

Completed·UUniversity of Thessaly··NCT05147155·130 enrolled

Show 31 more trials

Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma

Completed·MMedical University of Lodz··NCT05091385·106 enrolled

Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

Completed· GSK logo

GSK·Phase 3·NCT01691521·580 enrolled

A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma

Completed· GSK logo

GSK·Phase 3·NCT03562195·300 enrolled

Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma

Completed· GSK logo

GSK·Phase 2·NCT01000506·621 enrolled

Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients

Completed· GSK logo

GSK·Phase 4·NCT02654145·145 enrolled

Unknown status·—··NCT04665141·600 enrolled

MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects

Completed· GSK logo

GSK·Phase 3·NCT01691859·347 enrolled

This Record Contains Information About the Mepolizumab Compassionate Use (CU) Product Activities: 104317: CU and Long-Term Access Study of Mepolizumab in HES. 201956:A Long-term Access Programme for Subjects With Severe Asthma 112562: Expanded Access for Patients With Hypereosinophilic

No longer available· GSK logo

GSK··NCT00244686

Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab".

Unknown status·UUniversity of Newcastle, Australia·Phase 4·NCT04585997·200 enrolled

Functional Lung MRI for Early Treatment Response Assessment for Patients With Eosinophilic Asthma

Unknown status·HHannover Medical School··NCT04512521·40 enrolled

Effect of Mepolizumab on Decrease of Systemic Corticosteroids in Patients With Severe Eosinophilic Asthma

Completed·UUniversity Hospital, Grenoble··NCT03453021·27 enrolled

Efficacy and Safety Study of Mepolizumab 100 Milligram (mg) Subcutaneous (SC) in Indian Participants Aged Greater Than or Equal to (>=) 18 Years With Severe Eosinophilic Asthma

Completed· GSK logo

GSK·Phase 4·NCT04276233·100 enrolled

Study of Mepolizumab Safety Syringe in Asthmatics

Completed· GSK logo

GSK·Phase 3·NCT03021304·56 enrolled

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

Completed· GSK logo

GSK·Phase 3·NCT04718389·1,719 enrolled

Study for Children & Adolescent With Severe Asthma With an Eosinophilic Phenotype Treated With Mepolizumab

Active, not recruiting·KKing's College Hospital NHS Trust··NCT05139381·148 enrolled

Mepolizumab Steroid-Sparing Study in Subjects With Severe Refractory Asthma

Completed· GSK logo

GSK·Phase 3·NCT01691508·135 enrolled

REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study

Active, not recruiting· GSK logo

GSK·Phase 4·NCT06041386·336 enrolled

A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects

Completed· GSK logo

GSK·Phase 3·NCT02135692·339 enrolled

A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects

Completed· GSK logo

GSK·Phase 3·NCT01842607·651 enrolled

Study of Mepolizumab Autoinjector in Asthmatics

Completed· GSK logo

GSK·Phase 3·NCT03099096·159 enrolled

Blood Leukocyte Profiling in Eosinophilic Type 2 Asthma: Influence of Systemic IL-5 Targeting

Unknown status·RRegion Skane··NCT05689931·80 enrolled

Effects of Mepolizumab Compared to Placebo on Airway Physiology in Patients With Eosinophilic Asthma: MEMORY Study

Terminated·JJohannes Gutenberg University Mainz·Phase 3·NCT02594332·29 enrolled

Severe Asthma Exacerbations and Mepolizumab Treatment

Unknown status·UUniversità degli Studi di Ferrara··NCT04914078·70 enrolled

Cessation Versus Continuation of Long-term Mepolizumab in Severe Eosinophilic Asthma Patients

Completed· GSK logo

GSK·Phase 3·NCT02555371·306 enrolled

Use of Nucala in Severe Asthma

Completed·FFrisius Medisch Centrum··NCT05441059·2,100 enrolled

Effect of Mepolizumab on Severe Eosinophilic Asthma

Unknown status·HHospital Clinico Universitario de Santiago··NCT04641741·30 enrolled

Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial Asthma

Recruiting·—··NCT05708300·57 enrolled

Efficacy of Mepolizumab in Severe Asthmatics on a Long Term (MESILICO)

Unknown status·—··NCT04612556·45 enrolled

A Pragmatic Study to Investigate the Efficacy and Safety of Mepolizumab in Severe Uncontrolled Asthma in Brazil

Unknown status·UUniversity of Sao Paulo General Hospital·Phase 4·NCT04228588·18 enrolled

Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils

Completed· GSK logo

GSK·Phase 2·NCT01366521·70 enrolled

A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03292588·335 enrolled

Hypereosinophilic syndrome6 trials

A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622

Completed· GSK logo

GSK·Phase 3·NCT03306043·102 enrolled

Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome

Terminated· GSK logo

GSK·Phase 3·NCT00097370·78 enrolled

Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

Completed· GSK logo

GSK·Phase 3·NCT00086658·86 enrolled

Show 3 more trials

Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES)

Completed· GSK logo

GSK·Phase 3·NCT02836496·108 enrolled

Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome

Completed·—·Phase 1/2·NCT00266565·24 enrolled

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

Completed· GSK logo

GSK·Phase 3·NCT04965636·16 enrolled

Chronic Rhinosinusitis With Nasal Polyps5 trials

A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps

Active, not recruiting·RRigshospitalet, Denmark·Phase 4·NCT05942222·220 enrolled

Role of Epithelial Barrier Integrity in Biologic Treatment Response of Severe Asthmatics With/Out Chronic Rhinosinusitis With Nasal Polyps (CRSwNP).

Unknown status·UUniversity of Crete··NCT05365841·85 enrolled

Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.

Recruiting·IInstituto de Investigación Marqués de Valdecilla·Approved·NCT07814924·75 enrolled

Show 2 more trials

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?

Active, not recruiting·CCentre hospitalier de l'Université de Montréal (CHUM)·Approved·NCT05902325·36 enrolled

The Role of IL5 in Epithelial Cell Integrity

Completed·JJohns Hopkins University·Phase 1·NCT05895929·17 enrolled

Chronic Rhinosinusitis4 trials

Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.

Unknown status·IInstituto de Investigación Marqués de Valdecilla·Phase 4·NCT05923047·75 enrolled

Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment

Recruiting·SSt. Paul's Sinus Centre·Phase 4·NCT05642806·90 enrolled

Mepolizumab Effectiveness in Patients With Chronic Rhinosinusitis, Nasal Polyps and Comorbid Severe Eosinophilic Asthma

Unknown status·NNational and Kapodistrian University of Athens··NCT06069310·60 enrolled

Show 1 more trial

Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Recruiting·UUniversitaire Ziekenhuizen KU Leuven··NCT06683261·300 enrolled

CRSwNP3 trials

th2 Modulation CRSwNP

Not yet recruiting·SSt. Paul's Sinus Centre·Phase 4·NCT06107101·40 enrolled

Real Life Study of Biologicals in Patients With Severe CRSwNP

Recruiting·UUniversity Hospital, Ghent··NCT05938972·180 enrolled

Mepolizumab to CRSwNP Through 12 Months - Randomised to FESS and Non-FESS Within the First 2 Weeks

Active, not recruiting·VVibeke Backer·Phase 4·NCT05598814·58 enrolled

33 more indications

Chronic Obstructive Pulmonary Disease3 trials

Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)

Completed· GSK logo

GSK·Phase 3·NCT02105961·674 enrolled

Study to Evaluate Efficacy and Safety of Mepolizumab for Frequently Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed· GSK logo

GSK·Phase 3·NCT02105948·837 enrolled

Mepolizumab in Chronic Obstructive Pulmonary Diseases (COPD) With Eosinophilic Bronchitis

Completed·MMcMaster University·Phase 3·NCT01463644·18 enrolled

Inflammation3 trials

Eosinophilic Airway Inflammation and Mepolizumab

Completed·UUniversity of Wisconsin, Madison·N/A·NCT00802438·38 enrolled

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

Active, not recruiting·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 3·NCT05138250·32 enrolled

Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)

Completed·HHelsinki University Central Hospital·Phase 4·NCT04823585·95 enrolled

Eosinophilic Granulomatosis With Polyangiitis3 trials

Assessing The Long-Term Effectiveness and Safety of Mepolizumab 300mg/Month in the European Real-Life Setting (Mepo Long-term Study)

Completed·EEuropean EGPA Study Group··NCT07591753·299 enrolled

Evaluation of MEpolizumab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind Study

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT05030155·102 enrolled

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

Active, not recruiting· GSK logo

GSK·Phase 3·NCT05263934·163 enrolled

Eosinophilic Esophagitis2 trials

Intravenous Mepolizumab In Children With Eosinophilic Esophagitis

Completed· GSK logo

GSK·Phase 2·NCT00358449·84 enrolled

Mepo for Eosinophilic Esophagitis (EoE) Study

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT03656380·66 enrolled

Granulomatosis with Polyangiitis2 trials

A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

Completed· GSK logo

GSK·Phase 3·NCT02020889·136 enrolled

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）

Recruiting· Guangdong Hengrui Pharmaceutical Co., Ltd logo

Guangdong Hengrui Pharmaceutical Co., Ltd·Phase 2/3·NCT05979051·166 enrolled

Interleukin2 trials

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT04183192·72 enrolled

Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines

Completed·KKU Leuven·Phase 4·NCT04412044·22 enrolled

Churg-Strauss syndrome2 trials

Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome

Completed·UUniversity Hospital Schleswig-Holstein·Phase 2·NCT00716651·10 enrolled

Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome

Completed·—·Phase 1/2·NCT00527566·10 enrolled

Tics2 trials

Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

Completed·BBio-Thera Solutions·Phase 1·NCT05576454·207 enrolled

A Study to Compare the Pharmacokinetics of Mepolizumab as a Liquid Drug in a Safety Syringe or an Autoinjector Versus Lyophilised Drug

Completed· GSK logo

GSK·Phase 3·NCT03014674·246 enrolled

Nasal Polyps2 trials

A Randomised, Double-blind, Parallel Group PhIII Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab as an Add on to Maintenance Treatment in Adults With Severe Bilateral Nasal Polyps - SYNAPSE (StudY in NAsal Polyps Patients to Assess the Safety and Efficacy of Mepolizumab)

Completed· GSK logo

GSK·Phase 3·NCT03085797·414 enrolled

A Randomised, Double-blind, Placebo Controlled, Parallel Group Phase III Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) / Eosinophilic Chronic Rhinosinusitis (ECRS) MERIT: Mepolizumab in Eosinophilic Chronic RhinosinusITis Study

Completed· GSK logo

GSK·Phase 3·NCT04607005·169 enrolled

Nasal polyposis1 trial

Mepolizumab in Nasal Polyposis

Completed· GSK logo

GSK·Phase 2·NCT01362244·109 enrolled

Coronary Artery Disease1 trial

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

Recruiting·XXijing Hospital·Phase 2·NCT06572267·18 enrolled

Observational Study1 trial

Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational Study

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06258772·199 enrolled

ART1 trial

Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921

Completed· GSK logo

GSK·Phase 3·NCT03298061·100 enrolled

Trial1 trial

Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial

Completed·UUniversity of Leicester·Phase 2/3·NCT04075331·238 enrolled

GAN1 trial

Evaluation of Volatile Organic Compounds in Mepolizumab Therapy

Unknown status·UUniversity Hospital Southampton NHS Foundation Trust··NCT04924478·60 enrolled

Children1 trial

Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children

Completed· GSK logo

GSK·Phase 2·NCT02377427·36 enrolled

COPD1 trial

Immunological Basis for Mepolizumab Activity in COPD

Unknown status·TTemple University·Phase 2·NCT05320939·30 enrolled

Fasciitis1 trial

Mepolizumab for Eosinophilic Fasciitis

Withdrawn·MMayo Clinic·Phase 1·NCT04305678

Costs1 trial

Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab

Completed·UUniversity Hospital, Montpellier··NCT04550780·7,938 enrolled

Treatment1 trial

Response and Remission to Treatment With Anti-IL5/IL5R Antagonists

Completed·UUniversité de Montréal··NCT06348173·109 enrolled

Bronchiectasis1 trial

Mepolizumab Effectiveness in Severe Eosinophilic Asthma and Bronchiectasis

Unknown status·—·N/A·NCT05189613·100 enrolled

Atopic Dermatitis1 trial

Efficacy and Safety Study of Mepolizumab in Subjects With Moderate to Severe Atopic Dermatitis

Terminated· GSK logo

GSK·Phase 2·NCT03055195·34 enrolled

Bullous Pemphigoid1 trial

Anti-IL-5 Therapy in Bullous Pemphigoid (BP)

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 2·NCT01705795·32 enrolled

Physical Activity1 trial

A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma

Unknown status·SSotiria General Hospital··NCT03739320·50 enrolled

Biomarker1 trial

Beyond EOsinophils: proteoMICS to Identify Potential Biomarker of Organ Damage and Response to MEPOLIZUMAB in EGPA

Enrolling by invitation·—·Phase 4·NCT07343661·90 enrolled

Angioedema1 trial

Mepolizumab in Episodic Angioedema With Eosinophilia

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04128371·5 enrolled

Sinus Surgery1 trial

Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP

Not yet recruiting·EEye & ENT Hospital of Fudan University·Phase 4·NCT07200336·360 enrolled

Esophagitis1 trial

An Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients

Completed· GSK logo

GSK·Phase 2·NCT00274703·10 enrolled

Chronic Cough1 trial

Mepolizumab for the Treatment of Chronic Cough With Eosinophilic Airways Diseases

Completed·MMcMaster University·Phase 4·NCT04765722·46 enrolled

Severe Eosinophilic Asthma1 trial

Biomarkers Evaluation and Effect of Mepolizumab on Lower and Upper Airways Inflammation in Severe Refractory Eosinophilic Asthma

Completed·IIstituti Clinici Scientifici Maugeri SpA··NCT05063981·15 enrolled

Pulmonary Disease, Chronic Obstructive1 trial

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Mepolizumab 100 mg SC as add-on Treatment in Participants With COPD Experiencing Frequent Exacerbations and Characterized by Eosinophil Levels (Study 208657)

Completed· GSK logo

GSK·Phase 3·NCT04133909·806 enrolled

Eosinophilic Granulomatous Vasculitis1 trial

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)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04157348·140 enrolled

Unspecified1 trial

Residual Exacerbations With Mepolizumab

Recruiting·LLaval University··NCT04578171·60 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 4, 2015

NUCALA

BLA BLA125526

Nov 4, 2015

NUCALA

NDA BLA125526

Feb 16, 2017

NUCALA

NDA BLA125526

Dec 12, 2017

NUCALA

NDA BLA125526

Jun 6, 2019

NUCALA

BLA BLA761122

Jun 6, 2019

NUCALA

NDA BLA761122

Jun 6, 2019

NUCALA

NDA BLA125526

Sep 12, 2019

NUCALA

NDA BLA761122

Sep 12, 2019

NUCALA

NDA BLA761122

Sep 12, 2019

NUCALA

NDA BLA125526

Sep 25, 2020

NUCALA

NDA BLA125526

Sep 25, 2020

NUCALA

NDA BLA761122

Jul 29, 2021

NUCALA

NDA BLA125526

Jul 29, 2021

NUCALA

NDA BLA761122

Jan 22, 2022

NUCALA

NDA BLA125526

Jan 22, 2022

NUCALA

NDA BLA761122

Mar 8, 2023

NUCALA

NDA BLA125526

Mar 8, 2023

NUCALA

NDA BLA761122

May 22, 2025

NUCALA

NDA BLA125526

Aug 6, 2025

NUCALA

NDA BLA761122

Sources

References

[1]
ClinicalTrials.gov — 97 trial records for Mepolizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nucala drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Mepolizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Mepolizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761122). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Interleukin-5 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

Nucala

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Asthma34 trials

Hypereosinophilic syndrome6 trials

Chronic Rhinosinusitis With Nasal Polyps5 trials

Chronic Rhinosinusitis4 trials

CRSwNP3 trials

Chronic Obstructive Pulmonary Disease3 trials

Inflammation3 trials

Eosinophilic Granulomatosis With Polyangiitis3 trials

Eosinophilic Esophagitis2 trials

Granulomatosis with Polyangiitis2 trials

Interleukin2 trials

Churg-Strauss syndrome2 trials

Tics2 trials

Nasal Polyps2 trials

Nasal polyposis1 trial

Coronary Artery Disease1 trial

Observational Study1 trial

ART1 trial

Trial1 trial

GAN1 trial

Children1 trial

COPD1 trial

Fasciitis1 trial

Costs1 trial

Treatment1 trial

Bronchiectasis1 trial

Atopic Dermatitis1 trial

Bullous Pemphigoid1 trial

Physical Activity1 trial

Biomarker1 trial

Angioedema1 trial

Sinus Surgery1 trial

Esophagitis1 trial

Chronic Cough1 trial

Severe Eosinophilic Asthma1 trial

Pulmonary Disease, Chronic Obstructive1 trial

Eosinophilic Granulomatous Vasculitis1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News