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Heart & blood

Pegcetacoplan

EvidenceFDA approved

ClassComplement C3 inhibitor (PEG peptide)

Pegcetacoplan is an FDA-approved peptide that blocks complement C3. Learn how Empaveli and Syfovre work, what each is approved for, and key safety points.

Reviewed by: William Maish, MD MBA MPH, Clinical Product Lead
Published: October 5, 2026
Last updated: October 5, 2026

Key takeaway

Pegcetacoplan is a peptide that blocks complement protein C3, a central node of the immune system's complement cascade, and is sold as two distinct products: Empaveli for the blood disorder paroxysmal nocturnal hemoglobinuria and two rare kidney diseases, and Syfovre, an eye injection for geographic atrophy. By acting at C3, it controls complement-driven damage more broadly than drugs that block the later protein C5. Empaveli has been FDA-approved in the U.S. since 2021 and Syfovre since 2023.

At a glance

What it is	A pegylated peptide inhibitor of complement C3
Approved for	Paroxysmal nocturnal hemoglobinuria and two rare kidney diseases, C3 glomerulopathy and primary IC-MPGN (Empaveli), and geographic atrophy from age-related macular degeneration (Syfovre)
Key fact	In the PEGASUS trial, Empaveli was superior to the C5 inhibitor eculizumab for raising hemoglobin in PNH
Route	Subcutaneous infusion (Empaveli); intravitreal injection (Syfovre)
Evidence strength	FDA approved

What is pegcetacoplan?

Pegcetacoplan is a pegylated cyclic peptide that binds complement component C3 and its activation fragment C3b. The complement system is part of innate immunity, and C3 sits at the center of its cascade, so blocking C3 dampens complement activity broadly. The same molecule is marketed as two separate products for very different diseases: Empaveli, a subcutaneous treatment for paroxysmal nocturnal hemoglobinuria (PNH), and Syfovre, an eye injection for geographic atrophy. It was developed under the code APL-2, with Empaveli approved in 2021 and Syfovre in 2023.

How does pegcetacoplan work?

Pegcetacoplan binds C3, the protein at the hub of the complement cascade, blocking its activation and the downstream steps that lead to cell destruction. In PNH, red blood cells lack the surface proteins that normally protect them from complement, so they are destroyed both within blood vessels and, importantly, by the earlier C3 step on the cell surface. Because pegcetacoplan acts at C3, it controls both pathways of this destruction, which is broader than the older drugs that block only the later C5 protein.

In the eye, complement overactivity is thought to contribute to the slow retinal cell loss of geographic atrophy, and injecting pegcetacoplan into the eye is intended to slow that progression. In the PEGASUS trial in PNH, pegcetacoplan was superior¹ to the C5 inhibitor eculizumab for improving hemoglobin over 16 weeks.

Is it FDA-approved?

Yes. The FDA has approved² pegcetacoplan under two brand names, as the table shows:

Year	Product	Approved for
2021	Empaveli	PNH
2023	Syfovre	Geographic atrophy secondary to age-related macular degeneration
2025	Empaveli	C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), 2 rare kidney diseases

Empaveli carries a boxed warning for serious infections caused by encapsulated bacteria, so it requires vaccination against those bacteria and is available only through a restricted program.

What is pegcetacoplan prescribed for?

Empaveli is prescribed for adults with paroxysmal nocturnal hemoglobinuria, and for people 12 and older with C3 glomerulopathy or primary IC-MPGN to reduce protein in the urine. Syfovre is prescribed for geographic atrophy, an advanced form of dry age-related macular degeneration, given as an injection into the eye by an ophthalmologist.

What are the side effects?

According to the prescribing information, common side effects include:

For Empaveli: injection-site reactions, infections, diarrhea, and abdominal pain
For Syfovre: eye discomfort, floaters, and bleeding on the surface of the eye

More serious considerations include:

For Empaveli: serious infections with encapsulated bacteria such as meningococcus, requiring vaccination and a risk management program, and the possibility of hemolysis if treatment is stopped
For Syfovre: eye infection (endophthalmitis), retinal detachment, inflammation of retinal blood vessels, and a higher rate of converting to wet macular degeneration

More for heart & blood

Sources: FDA prescribing information for Empaveli and Syfovre; the PEGASUS trial (Hillmen et al., New England Journal of Medicine, 2021, DOI: 10.1056/NEJMoa2029073¹), indexed on PubMed. This document is educational and does not constitute medical advice.