Is Zilucoplan approved by the US FDA?

Drugs@FDA lists 1 application product line for Zilucoplan, including ZILBRYSQ (Prescription).

Is Zilucoplan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Zilucoplan: Zilbrysq.

Are there safety signals or safety updates for Zilucoplan?

US FDA: 1 entry (latest 2026-01-22).

Active substance

Zilucoplan

US FDA 1
EMA 1
Health Canada 3
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZILBRYSQ	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML); EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML); EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	solution · subcutaneous	UCB INC	Prescription	17 Oct 2023

EMA European Union — centrally authorised medicines

Zilbrysq UCB Pharma S.A. · Authorised · authorised 1 Dec 2023 · ATC L04AJ06

Therapeutic indication (EMA)

Zilbrysq is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ZILBRYSQ	02549220	16.6 MG / 0.416 ML	SOLUTION · SUBCUTANEOUS	UCB CANADA INC
ZILBRYSQ	02549239	23 MG / 0.574 ML	SOLUTION · SUBCUTANEOUS	UCB CANADA INC
ZILBRYSQ	02549247	32.4 MG / 0.81 ML	SOLUTION · SUBCUTANEOUS	UCB CANADA INC

Safety signals and safety-related labeling changes

US FDA 22 Jan 2026 ZILBRYSQ — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for zilucoplan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.