Product Description
Mepolizumab is a fully humanized monoclonal antibody that targets IL-5 with high affinity and specificity, and prevents binding to the IL-5 receptor on the surface of eosinophils. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5046999/)
Mechanisms of Action: IL5 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Poland | Portugal | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States
Approved Indications: Acute Pain | Back Pain | Chronic Pain | Headache | Pain Unspecified | Spasm | Hypereosinophilic Syndrome | Granuloma | Granulomatosis with Polyangiitis | Eosinophilic Granuloma | Arthralgia | Asthma | Status Asthmaticus | Nasal Polyposis | Sinusitis | Herpes Zoster | Back Pain | Headache | Pain Unspecified | Granuloma | Granulomatosis with Polyangiitis | Eosinophilic Granuloma | Asthma
Known Adverse Events: Acute Pain | Back Pain | Headache | Pain Unspecified | Spasm | Arthralgia | Asthma | Status Asthmaticus
Company: GlaxoSmithKline
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 19
Highest Development Phases
Phase 3: Asthma|Chronic Obstructive Pulmonary Disease|Churg-Strauss Syndrome|Eosinophilia|Eosinophilic Granuloma|Granulomatosis with Polyangiitis|Hypereosinophilic Syndrome|Nasal Polyposis|Sinusitis|Systemic Vasculitis
Phase 2: COVID-19|Eosinophilic Esophagitis|Respiratory Insufficiency
Phase 1: Chronic Spontaneous Urticaria
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 104317 | P3 |
Unknown Status |
Hypereosinophilic Syndrome |
2025-03-30 |
|
| IRB00363909 | P1 |
Recruiting |
Nasal Polyposis|Sinusitis |
2025-01-01 |
|
| SPHERE | P3 |
Active, not recruiting |
Hypereosinophilic Syndrome |
2024-11-25 |
|
| SPHERE | P3 |
Recruiting |
Hypereosinophilic Syndrome |
2024-09-16 |
79% |