Data updated: May 26, 2026
NUCALA (mepolizumab)
Interleukin-5 Antagonists
Trial Activity: Stable 9 active trials
Respiratory
Approved 2015-11-04
NUCALA is indicated for the treatment of Asthma; Chronic Rhinosinusitis; Chronic Obstructive Pulmonary Disease; Eosinophilic Granulomatosis with Polyangiitis; Hypereosinophilic Syndrome.
Development Insights
GlaxoSmithKline conducting 23 trials (53%)
25 indications explored (Broad Platform)
→ asthma (16 trials)
→ chronic rhinosinusitis with nasal polyps (4 trials)
→ nasal polyps (4 trials)
7
Indications
--
Phase 3 Trials
2
Priority Reviews
10
Years on Market
Details
- Status
- Prescription
- First Approved
- 2015-11-04
- Patent Cliff
- 2027
- Routes
- SUBCUTANEOUS, SUBCUTANEOUS LYOPHILIZED POWER
- Dosage Forms
- INJECTABLE
NUCALA Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 2015 to 2025 · 4 indication expansions
What NUCALA Treats
5 indicationsNUCALA is approved for 5 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Chronic Rhinosinusitis
- Chronic Obstructive Pulmonary Disease
- Eosinophilic Granulomatosis with Polyangiitis
- Hypereosinophilic Syndrome
Source: FDA Label
NUCALA Target & Pathway
ProTarget
NUCALA Competitive Set
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Direct competitors
2
Same target(s) AND same indication — head-to-head.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
37 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04157348 MANDARA results posted | D3253C00001 2023-510248-19-00, 2019-001832-77 | Ph 3 | active not recruiting | Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab. |
| NCT04965636 SPHERE results posted | 215360 | Ph 3 | completed | Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE) |
| NCT04075331 COPD-HELP results posted | 0690 | Ph 2, Ph 3 | completed | Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial |
| NCT04823585 AirGOs-biol results posted | HUS/686/2020 | Ph 4 | completed | Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab) |
| NCT05030155 E-merge | D20180135 2020-003318-10 | Ph 3 | active not recruiting | Study of Mepolizumab-based Regimen Compared to Conventional Therapeutic Strategy in Patients With Eosinophilic Granulomatosis With Polyangiitis (E-merge) |
| NCT05263934 OCEAN | 217102 2023-510019-20-00 | Ph 3 | active not recruiting | Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) |
| NCT04718389 NIMBLE results posted | 206785 | Ph 3 | completed | A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype |
| NCT07200336 | NPESS-2025 | Ph 4 | not yet recruiting | Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP |
| NCT01463644 results posted | RP11-3588 | Ph 3 | completed | Mepolizumab in Chronic Obstructive Pulmonary Diseases (COPD) With Eosinophilic Bronchitis |
| NCT04765722 MUCOSA results posted | ISS-21-4463 | Ph 4 | completed | Mepolizumab for the Treatment of Chronic Cough With Eosinophilic Airways Diseases |
| NCT04133909 MATINEE results posted | 208657 | Ph 3 | completed | Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level |
| NCT06041386 REIMAGINE | 219871 | Ph 4 | active not recruiting | REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study |
| NCT05942222 TORNADO | 2022-ENT-3 | Ph 4 | active not recruiting | A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps |
| NCT04276233 PRISM results posted | 209682 | Ph 4 | completed | 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 |
| NCT04607005 MERIT results posted | 209692 | Ph 3 | completed | Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS) |
| NCT04305678 | 19-011851 | Ph 1 | withdrawn | Mepolizumab for Eosinophilic Fasciitis |
| NCT04183192 results posted | SCR-006 | Ph 1 | completed | Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists |
| NCT04128371 results posted | 200002 20-I-0002 | Ph 2 | terminated | Mepolizumab in Episodic Angioedema With Eosinophilia |
| NCT03298061 results posted | 116841 2014-003162-25 | Ph 3 | completed | Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921 |
| NCT01691859 results posted | 115666 2012-001643-51 | Ph 3 | completed | MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects |
| NCT03099096 results posted | 204959 2016-001832-36 | Ph 3 | completed | Study of Mepolizumab Autoinjector in Asthmatics |
| NCT03292588 MUPPITS-2 results posted | DAIT ICAC-30 UM1AI114271, NIAID CRMS ID#: 38189 | Ph 2 | completed | A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children |
| NCT03085797 results posted | 205687 2016-004255-70 | Ph 3 | completed | Effect of Mepolizumab in Severe Bilateral Nasal Polyps |
| NCT01362244 results posted | 111782 2008-003772-21 | Ph 2 | completed | Mepolizumab in Nasal Polyposis |
| NCT03306043 results posted | 205203 2017-000184-32 | Ph 3 | completed | A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622 |
| NCT02135692 results posted | 201312 2014-000314-54 | Ph 3 | completed | A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects |
| NCT02377427 results posted | 200363 2014-002666-76 | Ph 2 | completed | Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children |
| NCT03021304 results posted | 205667 2016-001831-10 | Ph 3 | completed | Study of Mepolizumab Safety Syringe in Asthmatics |
| NCT02105948 results posted | 117106 | Ph 3 | completed | Study to Evaluate Efficacy and Safety of Mepolizumab for Frequently Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients |
| NCT02105961 results posted | 117113 | Ph 3 | completed | Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD) |
| NCT02281318 results posted | 200862 | Ph 3 | completed | Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control |
| NCT01842607 results posted | 115661 | Ph 3 | completed | A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects |
| NCT02020889 results posted | 115921 | Ph 3 | completed | A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis |
| NCT02594332 MEMORY | 2015-001 2015-001868-19 | Ph 3 | terminated | Effects of Mepolizumab Compared to Placebo on Airway Physiology in Patients With Eosinophilic Asthma: MEMORY Study |
| NCT01691508 results posted | 115575 | Ph 3 | completed | Mepolizumab Steroid-Sparing Study in Subjects With Severe Refractory Asthma |
| NCT01366521 results posted | 114092 | Ph 2 | completed | Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils |
| NCT00716651 MEPOCHUSS | RBB1 EudraCT 2006-001791-20 | Ph 2 | completed | Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NUCALA FDA Label Details
Indications & Usage
FDA Label (PDF)NUCALA is indicated for the treatment of Asthma; Chronic Rhinosinusitis; Chronic Obstructive Pulmonary Disease; Eosinophilic Granulomatosis with Polyangiitis; Hypereosinophilic Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment