BLAIV (INFUSION)INJECTABLEPriority Review
Approved
Mar 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
69
Data completeness
4/8 — Partial
Priority Review
SOLIRIS (eculizumab) by AstraZeneca is complement inhibitors [moa]. First approved in 2007.
Drug data last refreshed 8h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOLIRIS (eculizumab) is a complement C5 inhibitor administered intravenously that blocks the terminal complement pathway to prevent cell lysis and inflammation. It is approved for rare and serious complement-mediated diseases including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG). The drug works by binding to C5 complement protein, preventing activation of the membrane attack complex.
$223MPart D
LOE ApproachingSOLIRIS is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling defensive positioning and potential downsizing of legacy brand teams as next-generation complement inhibitors gain market share.
Mechanism of Action
Complement Inhibitors
Pharmacologic Class:
Complement Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (69)
Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris
Started Jan 2027
12 enrolled
Paroxysmal Nocturnal Hemoglobinuria
A Study of the Efficacy and Safety of FXS6837 Capsules Compared to Eculizumab for 24 Weeks in Patients With PNH.
Started Dec 2026
90 enrolled
Paroxysmal Nocturnal Hemoglobinuria
Study of NM8074 in Soliris-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Started Jun 2026
6 enrolled
PNH - Paroxysmal Nocturnal Hemoglobinuria
Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis
Started Aug 2025
6 enrolled
Paroxysmal Nocturnal HemoglobinuriaPNHExtravascular Hemolysis
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD
Started Jan 2025
21 enrolled
NMOSDNeuromyelitis Optica Spectrum Disorders
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.