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Pegcetacoplan Reference

Educational, not medical advice reference for Pegcetacoplan: Immune; regulatory status, evidence posture, source review, and schedule notes. Als…

Reference summary

Pegcetacoplan is a label-verified complement C3 inhibitor with FDA Phase 3 evidence in PNH and C3G / IC-MPGN (Empaveli) and geographic atrophy (Syfovre). pepSmart surfaces label-reference content only.

Regulatory and posture

Categories
Immune
Aliases
Empaveli, Syfovre, APL-2, Pegylated cyclic peptide complement C3 inhibitor
Evidence posture
human - Empaveli carries label warnings for serious infections caused by encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae) and requires meningococcal, pneumococcal, and Hib vaccination per label before initiation. Syfovre labeling notes intraocular inflammation (including retinal vasculitis) and increased risk of neovascular age-related macular degeneration.
Regulatory status
FDA-approved prescription medication shipping as two distinct branded products. Empaveli (initial US approval 2021) is indicated for adults with paroxysmal nocturnal hemoglobinuria (PNH) and, since July 28, 2025, for C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 and older; subcutaneous infusion via on-body infusor. Syfovre (initial US approval 2023) is indicated for geographic atrophy (GA) secondary to age-related macular degeneration; intravitreal injection administered by an ophthalmologist. Pegylated cyclic peptide that binds complement C3. The two products are not interchangeable and must be used per their respective labels.
Content review status
label verified

Selected public sources

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