mepolizumab
Trade name: Nucala
mAbapprovedOrphan Drug FDA
Approved
Nov 4, 2015
Mepolizumab, sold under the brand name Nucala by GlaxoSmithKline, is a humanized monoclonal antibody used for the treatment of severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome. — Wikipedia
Clinical trial activity
88 trials · 65 clinical orgs · 1 marketing orgs
Phase 1
12
Phase 2
53
Phase 3
36
Phase 4
18
Earliest trial started Dec 1, 2001 (NCT00266565)
Timeline
2000s
- Jan 1, 2001
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2004
GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2004
GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)
- May 28, 2004
Orphan Drug Designation
2010s
- Nov 4, 2015
GlaxoSmithKline — Earliest FDA Approval
- Nov 4, 2015
GlaxoSmithKline — Marketing Organization
- Nov 4, 2015
GlaxoSmithKline — NDA Organization
Indications
Studied for
- Airway Management · Phase 3
- Angioedema · Phase 2
- Bronchitis · Phase 4
- Chronic Urticaria · Early Phase 1
- Churg-Strauss Syndrome · Phase 3
- Coronary Artery Disease · Phase 2
- Cough · Phase 4
- COVID-19 · Phase 3
- Dermatitis, Atopic · Phase 2
- Eosinophilia · Phase 4
- Eosinophilic Esophagitis · Phase 2
- Eosinophilic Granuloma · Phase 3
- Eosinophils · Phase 2
- Esophagitis · Phase 2
- Gastroenteritis · Phase 1/Phase 2
- Granulomatosis with Polyangiitis · Early Phase 1
- Healthy Volunteers · Phase 1
- Hypereosinophilic Syndrome · Phase 3
- Lymphohistiocytosis, Hemophagocytic · Early Phase 1
- Malaria · Phase 2
- Malaria, Falciparum · Phase 1
- Nasal Polyps · Phase 4
- Pemphigoid, Bullous · Phase 2
- Pharmacokinetics · Phase 1
- Post-Acute COVID-19 Syndrome · Phase 3
- Pulmonary Disease, Chronic Obstructive · Phase 3
- Sinusitis · Phase 4
- Virus Diseases · Phase 3
Mechanism of action
- Interleukin-5INHIBITOR
IL5 inhibitor
Approval history
- approvedNov 4, 2015
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaMepolizumab ↗
- NCATS90Z2UF0E52 ↗
- ChEMBLCHEMBL2108429 ↗
Also known as
- bosatria
- mepolizumab
- mepolizumab
- mepolizumab
- mepolizumab
- mepolizumab
- mepolizumab
- mepolizumab
- mepolizumab
- mepolizumab
- mepolizumab
- nucala
- nucala
- nucala
- nucala
- nucala
- sb240563
- sb 240563
- sb-240563
- sb-240563
- sb-240563
- sb-240563
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07200336 | Phase 4 | Oct 8, 2025 | Fudan University |
| NCT07268313 | Phase 4 | Apr 3, 2025 | University of Copenhagen |
| NCT06572267 | Phase 2 | Oct 16, 2024 | Xijing Hospital |
| NCT06501807 | N/A | Sep 2, 2024 | University of Lille |
| NCT06107101 | Phase 4 | Jan 1, 2024 | St. Paul's Sinus Centre |
| NCT06040346 | Phase 2 | Dec 15, 2023 | Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd |
| NCT06041386 | Phase 4 | Nov 16, 2023 | GlaxoSmithKline |
| NCT05902325 | Phase 4 | Oct 3, 2023 | University of Montreal |
| NCT05895929 | Early Phase 1 (Phase 1) | Sep 5, 2023 | GlaxoSmithKline, Johns Hopkins University |
| NCT05923047 | Phase 4 | Sep 1, 2023 | University of Cantabria |
| NCT05679492 | Phase 3 | May 30, 2023 | Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd |
| NCT05942222 | Phase 4 | Apr 27, 2023 | University of Copenhagen |
| NCT05813587 | Phase 3 | Mar 23, 2023 | Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd |
| NCT05598814 | Phase 4 | Jan 31, 2023 | University of Copenhagen |
| NCT05642806 | Phase 4 | Jan 30, 2023 | St. Paul's Sinus Centre |
| NCT05679479 | Phase 3 | Jan 21, 2023 | Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd |
| NCT05626777 | Phase 4 | Nov 30, 2022 | Croix-Rousse Hospital, Lyon, GlaxoSmithKline, University of Lyon |
| NCT05320939 | Phase 2 | Oct 31, 2022 | GlaxoSmithKline, Temple University |
| NCT05576454 | Phase 1 | Sep 20, 2022 | Biothera, Jinlin University |
| NCT05263934 | Phase 3 | Jul 14, 2022 | GlaxoSmithKline |
Showing 20 of 88 trials
Page 1 / 5
Organizations
Research & Development (65)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 52 | 37 | 5 | 2004 |
| Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | For profit | 7 | 7 | 3 | 2020 |
| McMaster University | Academic/Hospital | 3 | 2 | 3 | 2005 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 3 | 2 | 2 | 2014 |
| University of Copenhagen | Academic/Hospital | 3 | 3 | 1 | 2023 |
| Katholieke Universiteit Leuven | Academic/Hospital | 2 | 1 | 1 | 2016 |
| Mayo Clinic | Academic/Hospital | 2 | 2 | 1 | 2018 |
| Signant Health | For profit | 2 | 0 | 1 | 2017 |
| St. Paul's Sinus Centre | Academic/Hospital | 2 | 2 | 1 | 2023 |
| University of Wisconsin | Academic/Hospital | 2 | 1 | 2 | 2008 |
| Xijing Hospital | Academic/Hospital | 2 | 2 | 2 | 2020 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 1 | 1 | 1 | 2021 |
| AstraZeneca | For profit | 1 | 1 | 1 | 2019 |
| AZ Delta Roeselare | Academic/Hospital | 1 | 0 | 1 | 2018 |
| BioClinica, Inc. | For profit | 1 | 0 | 1 | 2021 |
| Biothera | For profit | 1 | 1 | 1 | 2022 |
| Bristol-Myers Squibb | For profit | 1 | 0 | 1 | 2017 |
| CHU Charleroi | Academic/Hospital | 1 | 0 | 1 | 2018 |
| CHU Mont-Godinne | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Cliniques universitaires Saint-Luc | Academic/Hospital | 1 | 0 | 1 | 2018 |
65 organizations
Page 1 / 4
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | MKTG | Nov 4, 2015 |
| GlaxoSmithKline | For profit | SYN | Jun 6, 2019 |
| GlaxoSmithKline | For profit | NDA | Nov 4, 2015 |