Zilucoplan dosage in published studies and labels

These are the doses used for Zilucoplan 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

Zilucoplan has an FDA-approved human dosage. As Zilbrysq it is a once-daily subcutaneous injection set by body weight: 16.6 mg under 56 kg, 23 mg from 56 kg to under 77 kg, and 32.4 mg at 77 kg and above, for adults with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive. It carries a boxed warning for meningococcal infection and is available only through a REMS program.

FDA Approved

Dosage evidence summary for Zilucoplan
Human dosing established	Yes
Studied dose range	16.6–32.4 mg once daily, by body weight
Route	Subcutaneous
Frequency	Once daily
Duration studied	Continuous
Titration	None. The dose is fixed by weight band. Before the first dose, the label requires meningococcal vaccination at least 2 weeks ahead (unless delay is riskier than the infection) and baseline lipase and amylase levels.
Half-life	About 172 hours (7 to 8 days)
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 Zilucoplan, one row per studied regimen
Study / context	Population	Dose	Route	Frequency	Duration	Outcome studied	Source
FDA label — Zilbrysq (revised October 2026)FDA-approved label · FDA prescribing information	Adults with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive	16.6 mg under 56 kg; 23 mg at 56 to under 77 kg; 32.4 mg at 77 kg and above	Subcutaneous, by prefilled syringe or autoinjector	Once daily	Continuous	Improvement in myasthenia gravis symptoms	ZILBRYSQ (zilucoplan) injection — FDA prescribing information, revised 10/2026 (Drugs@FDA)
Howard et al., 2023 — RAISE, phase 3Clinical trial · Randomised, double-blind, placebo-controlled phase 3	Adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (86 on zilucoplan, 88 on placebo)	0.3 mg/kg	Subcutaneous self-injection	Once daily	12 weeks	MG-ADL score improved by 4.39 points versus 2.30 on placebo	Howard JF Jr et al. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Neurol. 2023.
Howard et al., 2020 — phase 2Clinical trial · Randomised, double-blind, placebo-controlled phase 2	Adults with moderate to severe generalized myasthenia gravis (n=44)	0.1 or 0.3 mg/kg	Subcutaneous self-injection	Once daily	12 weeks	QMG and MG-ADL scores improved at 0.3 mg/kg; the 0.1 mg/kg effect was slower and smaller	Howard JF Jr et al. Clinical Effects of the Self-administered Subcutaneous Complement Inhibitor Zilucoplan in Patients With Moderate to Severe Generalized Myasthenia Gravis: Results of a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial. JAMA Neurol. 2020.
Howard et al., 2024 — RAISE-XT, open-label extension (interim)Clinical trial · Open-label phase 3 extension, interim analysis	Patients from the phase 2 and phase 3 trials (n=200; median exposure 1.2 years)	0.3 mg/kg	Subcutaneous self-injection	Once daily	Ongoing at the interim analysis, up to 4.45 years	MG-ADL improvements held through week 60; 94% had an adverse event, most often worsening myasthenia gravis or COVID-19	Howard JF Jr et al. Long-term safety and efficacy of zilucoplan in patients with generalized myasthenia gravis: interim analysis of the RAISE-XT open-label extension study. Ther Adv Neurol Disord. 2024.
Paganoni et al., 2025 — HEALEY ALS Platform Trial (not an approved use)Clinical trial · Randomised, double-blind, placebo-controlled phase 2/3 platform trial	People with amyotrophic lateral sclerosis (122 on zilucoplan, 40 on matching placebo)	0.3 mg/kg	Subcutaneous	Once daily	Planned 24 weeks	Stopped early for futility; no change in disease progression	Paganoni S et al. Efficacy and Safety of Zilucoplan in Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial. JAMA Netw Open. 2025.
Mammen et al., 2023 — immune-mediated necrotizing myopathy, phase 2 (not an approved use)Clinical trial · Randomised, double-blind, placebo-controlled phase 2	Adults with anti-HMGCR or anti-SRP antibody-positive myopathy (12 on zilucoplan, 15 on placebo)	0.3 mg/kg	Subcutaneous	Once daily	8 weeks	No meaningful difference from placebo in creatine kinase; the study was terminated	Mammen AL et al. Zilucoplan in immune-mediated necrotising myopathy: a phase 2, randomised, double-blind, placebo-controlled, multicentre trial. Lancet Rheumatol. 2023.
NCT03078582 — PNH, phase 2 (not an approved use)Clinical trial · Phase 2 trial with posted results	Patients with paroxysmal nocturnal hemoglobinuria (n=26), treatment-naive or previously on eculizumab	0.3 mg/kg on day 1, then 0.1 mg/kg daily to start	Subcutaneous	Once daily	—	Results posted on the registry	NCT03078582 — Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients

Preclinical and analog research

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

Research-reported dosing for Zilucoplan, one row per studied regimen
Study / context	Population	Dose	Route	Frequency	Duration	Outcome studied	Source
Preclinical — animal reproduction studyPreclinical · Animal toxicology reported in the FDA label	Pregnant monkeys	1, 2 or 4 mg/kg/day; not convertible to a human dose	Subcutaneous	Daily through gestation	—	More embryofetal deaths at all doses, with no maternal toxicity; no no-effect dose was identified	ZILBRYSQ (zilucoplan) injection — FDA prescribing information, section 8.1 (Drugs@FDA)

Where sources disagree

The trials dosed zilucoplan at 0.3 mg/kg. The label turns that into three fixed weight bands, so the labeled dose in mg/kg varies a little within each band.
The label is limited to adults who are anti-AChR antibody positive. Trials in ALS and immune-mediated necrotizing myopathy found no benefit, and safety and effectiveness have not been established in children.
DailyMed's copy of the label predated the October 2026 FDA revision at this review. That revision added the autoinjector and left the dose unchanged.
RAISE was 12 weeks long. Longer-term signals come from open-label extensions: pancreatitis or pancreatic cysts in 3.3% of patients, and morphea in 5%, usually after more than a year.