Pegcetacoplan dosage in published studies and labels

These are the doses used for Pegcetacoplan in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.

Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.

Last checked against primary sources: October 30, 2026

Studied regimens and sources

Pegcetacoplan has two FDA-approved products with very different doses. Empaveli is 1,080 mg by subcutaneous infusion twice weekly for adults with paroxysmal nocturnal hemoglobinuria and for people aged 12 and older with C3 glomerulopathy or primary immune-complex MPGN, with weight-based dosing for adolescents under 50 kg. Syfovre is 15 mg injected into the eye every 25 to 60 days for geographic atrophy.

FDA Approved

Dosage evidence summary for Pegcetacoplan
Human dosing established	Yes
Studied dose range	1,080 mg twice weekly under the skin (Empaveli); 15 mg into the eye every 25 to 60 days (Syfovre)
Route	Subcutaneous infusion · Intravitreal
Frequency	Twice weekly (Empaveli); every 25 to 60 days (Syfovre)
Duration studied	Continuous
Titration	None in adults. In PNH, an LDH above twice the upper limit of normal moves dosing to 1,080 mg every 3 days. Adolescents with C3G or primary IC-MPGN follow a weight schedule: from 35 kg to under 50 kg, 648 mg then 810 mg twice weekly; under 35 kg, 540 mg for two doses then 648 mg twice weekly.
Half-life	Effective half-life 8.6 days in PNH, 10.2 days in C3G and 10.8 days in primary IC-MPGN (Empaveli, subcutaneous)
Evidence level	FDA Approved
Last reviewed	2026-10-30

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Pegcetacoplan, one row per studied regimen
Study / context	Population	Dose	Route	Frequency	Duration	Outcome studied	Source
FDA label — Empaveli, PNHFDA-approved label · FDA prescribing information	Adults with paroxysmal nocturnal hemoglobinuria (PNH)	1,080 mg; 1,080 mg every 3 days if LDH exceeds twice the upper limit of normal	Subcutaneous infusion	Twice weekly	Continuous	Treatment of paroxysmal nocturnal hemoglobinuria	EMPAVELI (pegcetacoplan) injection — FDA prescribing information, DailyMed
FDA label — Empaveli, C3G and primary IC-MPGNFDA-approved label · FDA prescribing information	Adults and children aged 12 and older with C3 glomerulopathy or primary immune-complex MPGN	1,080 mg in adults and at 50 kg or more; 810 mg at 35 to under 50 kg; 648 mg under 35 kg (after the labeled first doses)	Subcutaneous infusion	Twice weekly	Continuous	Reduced proteinuria and loss of kidney function	EMPAVELI (pegcetacoplan) injection — FDA prescribing information, section 2.3, DailyMed
FDA label — SyfovreFDA-approved label · FDA prescribing information	Geographic atrophy secondary to age-related macular degeneration	15 mg (0.1 mL of 150 mg/mL) in each affected eye	Intravitreal injection by a physician	Once every 25 to 60 days	Continuous	Slower growth of geographic atrophy lesions	SYFOVRE (pegcetacoplan) injection — FDA prescribing information, DailyMed
Hillmen et al., 2021 — PEGASUS, phase 3Clinical trial · Open-label, randomised, active-controlled phase 3	Adults with PNH and hemoglobin below 10.5 g/dL despite eculizumab (41 on pegcetacoplan, 39 on eculizumab)	1,080 mg	Subcutaneous	Twice weekly	16 weeks after a 4-week run-in	Hemoglobin rose 3.84 g/dL more than with eculizumab at week 16	Hillmen P et al. Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria. N Engl J Med. 2021.
Wong et al., 2023 — PRINCE, phase 3Clinical trial · Open-label, randomised, controlled phase 3	Complement inhibitor-naive adults with PNH (35 on pegcetacoplan, 18 on supportive care)	1,080 mg	Subcutaneous	Twice weekly	26 weeks	Hemoglobin stabilized in 85.7% versus none on supportive care	Wong RSM et al. Pegcetacoplan controls hemolysis in complement inhibitor-naive patients with paroxysmal nocturnal hemoglobinuria. Blood Adv. 2023.
Fakhouri et al., 2025 — VALIANT, phase 3Clinical trial · Randomised, double-blind, placebo-controlled phase 3	Adolescents and adults with C3 glomerulopathy or primary immune-complex MPGN, native or post-transplant (n=124)	1,080 mg, or weight-based in smaller adolescents	Subcutaneous infusion	Twice weekly	26 weeks, then 26 weeks open-label	Urine protein-to-creatinine ratio fell 68.1% relative to placebo at week 26	Fakhouri F et al. Trial of Pegcetacoplan in C3 Glomerulopathy and Immune-Complex MPGN. N Engl J Med. 2025.
Heier et al., 2023 — OAKS and DERBY, phase 3Clinical trial · Two randomised, double-masked, sham-controlled phase 3 trials	Adults aged 60 and older with geographic atrophy (n=1,258)	15 mg per 0.1 mL	Intravitreal	Monthly or every other month, versus sham	24 months	Lesion growth slowed by 16% to 22% versus sham at 24 months; no difference in key visual function endpoints	Heier JS et al. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials. Lancet. 2023.
NCT04579666 — MERIDIAN, ALS, phase 2 (not an approved use)Clinical trial · Randomised, placebo-controlled phase 2 with posted results	Adults with amyotrophic lateral sclerosis (n=249)	1,080 mg	Subcutaneous	Twice weekly	—	Terminated: did not meet its primary or key secondary efficacy endpoints at week 52	NCT04579666 — MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)
Roman et al., 2025 — autoimmune hemolytic anemia, phase 2 (not an approved use)Clinical trial · Open-label phase 2	Patients with cold agglutinin disease (n=13) or warm antibody autoimmune hemolytic anemia (n=11)	270 or 360 mg	Subcutaneous	Daily	Up to 48 weeks	Median hemoglobin rose 2.4 g/dL in cold agglutinin disease and 1.7 g/dL in warm antibody disease at week 48	Roman E et al. Safety and efficacy of pegcetacoplan treatment for cold agglutinin disease and warm antibody autoimmune hemolytic anemia. Blood. 2025.

Preclinical and analog research

Not human dosing evidence. Listed for completeness and never extrapolated to a human dose.

Research-reported dosing for Pegcetacoplan, one row per studied regimen
Study / context	Population	Dose	Route	Frequency	Duration	Outcome studied	Source
Preclinical — animal toxicologyPreclinical · Animal toxicology reported in the FDA label	Rabbits and cynomolgus monkeys	Daily doses up to 7 times the human dose; not convertible to a human dose	Subcutaneous	Daily	—	Vacuolation in renal tubules and other tissues, attributed to PEG uptake; clinical significance uncertain	EMPAVELI (pegcetacoplan) injection — FDA prescribing information, section 13.2, DailyMed

Where sources disagree

A single "pegcetacoplan dose" means nothing without naming the product. Empaveli and Syfovre differ by more than 70-fold per dose, in route, schedule and disease, and the 15–1,080 mg span is not a range to move within.
The boxed warning for serious infections and the REMS program apply to Empaveli, the systemic product. Syfovre's main risks are in the eye, including retinal vasculitis and neovascular AMD.
In DERBY, slowing of lesion growth at the 12-month primary endpoint did not reach statistical significance (p=0.062 monthly, p=0.085 every other month), while OAKS did. Both trials were significant at 24 months.
FDA's August 2026 supplement added reducing the loss of kidney function to the C3G and IC-MPGN indication. In the NEJM report of VALIANT, eGFR was not formally tested in the statistical hierarchy; the label gives a difference of 6.31 mL/min/1.73 m2 at week 26 (95% CI 0.50 to 12.12).
The label's C3G and IC-MPGN indication does not cover recurrent IC-MPGN after kidney transplant, where safety and effectiveness have not been established.
Aspaveli is the European brand of the subcutaneous product. This page covers the US labels only.