NDAINTRAVITREALSOLUTIONPriority Review
Approved
Feb 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
SYFOVRE (pegcetacoplan) by Apellis Pharmaceuticals is complement inhibitors [moa]. Approved for geographic atrophy. First approved in 2023.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYFOVRE (pegcetacoplan) is an intravitreal complement inhibitor approved in February 2023 for geographic atrophy, a leading cause of blindness in elderly patients. It works by inhibiting complement C3, a key driver of retinal inflammation and cell death. The drug is being investigated across multiple complement-mediated conditions including glomerulonephritis, hemolytic anemias, and neurological disorders.
$0.002BPart D
Peak12.6 years to LOEProduct is in peak commercial phase with limited Part D penetration (500 claims in 2023), suggesting early-stage market expansion opportunity for sales and marketing teams.
Mechanism of Action
Complement Inhibitors
Pharmacologic Class:
Complement Inhibitor
Indications (1)
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
Worked on SYFOVRE at Apellis Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
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.