NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
EMPAVELI (pegcetacoplan) by Apellis Pharmaceuticals is complement inhibitors [moa]. First approved in 2021.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EMPAVELI (pegcetacoplan) is a subcutaneous complement inhibitor approved in May 2021 that blocks both C3 and C5 pathways to treat rare blood disorders driven by complement dysregulation. It is administered as a solution injection and represents a targeted approach to preventing hemolysis and related complications in complement-mediated diseases.
$25MPart D
Peak12.5 years to LOEProduct is at peak commercial stage with established market presence; commercial teams are likely focused on defending market share and optimizing field execution across a stable but modest patient base.
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 (20)
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
Started Feb 2026
320 enrolled
Delayed Graft FunctionEnd Stage Renal DiseaseDeceased Donor Kidney Transplant
Study to Evaluate a Pegcetacoplan (Syfovre®) Prefilled Syringe
Started Oct 2025
44 enrolled
Geographic Atrophy Secondary to Age-related Macular Degeneration
A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneratio
Started Jun 2025
240 enrolled
Geographic Atrophy Secondary to Age-related Macular Degeneration
A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Started Sep 2023
300 enrolled
Geographic Atrophy
A Real World Effectiveness Study of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Started Jun 2023
200 enrolled
Paroxysmal Nocturnal Hemoglobinuria
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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.