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Phase 3
Development Phase
0
Upcoming Catalysts
0
Historical Events
1
Regulatory Approvals
No catalyst events have been recorded for this drug yet.
2 competitors in Paroxysmal Nocturnal Hemoglobinuria
View Full LandscapeTarget Indication
Paroxysmal Nocturnal Hemoglobinuria
Clinical Trial
NCT03500549Last updated: 12/4/2025
No patent data available. Pre-approval drugs may not have Orange Book listings.
Soliris
Soliris is indicated in adults and children for the treatment of: Paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). Atypical haemolytic uremic syndrome (aHUS). Soliris is indicated in adults for the treatment of: Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1). Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.