Drug Profile

Eculizumab - Alexion AstraZencea Rare Disease

Alternative Names: 5G1-1; 5G1.1; Anti-C5 monoclonal antibody 5G1-1; h5G1.1; Monoclonal antibody 5G1-1; Soliris

Latest Information Update: 09 Jun 2025

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At a glance

Originator Alexion Pharmaceuticals
Developer Alexion AstraZeneca Rare Disease; Alexion Pharmaceuticals; Brigham and Womens Hospital; Handok Inc
Class Anti-inflammatories; Antiallergics; Antianaemics; Antiasthmatics; Antihypertensives; Antipsoriatics; Antirheumatics; Eye disorder therapies; Monoclonal antibodies; Neuroprotectants; Skin disorder therapies; Urologics
Mechanism of Action Complement C5 inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Paroxysmal nocturnal haemoglobinuria; Delayed graft function; Neuromyelitis optica; Transplant rejection; Haemolytic uraemic syndrome; Myasthenia gravis; Dermatomyositis; Membranous glomerulonephritis
New Molecular Entity Yes

Marketed Haemolytic uraemic syndrome; Myasthenia gravis; Neuromyelitis optica; Paroxysmal nocturnal haemoglobinuria
Phase III Delayed graft function; Guillain-Barre syndrome
Phase II Preeclampsia; Renal transplant rejection
No development reported Antiphospholipid syndrome; COVID-19 pneumonia; Heart transplant rejection; SARS-CoV-2 acute respiratory disease
Discontinued Adult respiratory distress syndrome; Age-related macular degeneration; Allergic asthma; Autoimmune haemolytic anaemia; Bullous pemphigoid; Dermatomyositis; Glomerulonephritis; Idiopathic thrombocytopenic purpura; Lupus nephritis; Membranous glomerulonephritis; Motor neuron disease; Psoriasis; Rheumatoid arthritis; Systemic lupus erythematosus

07 May 2025 Alexion Pharmaceuticals completes a phase II trial in Haemolytic uraemic syndrome (In children, In adolescents, In adults, In the elderly) in China (IV) (NCT05876351)
14 Apr 2025 Alexion Pharmaceuticals completes phase-III clinical trials in Paroxysmal nocturnal haemoglobinuria (Treatment-naive) in China (IV, infusion) (NCT05886244)
17 Jan 2025 Phase-III clinical trials in Myasthenia gravis (Treatment-experienced) in China (IV), (NCT06764160),

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