Zilucoplan

Overview

Zilucoplan is a 15 amino-acid, synthetic macrocyclic peptide. It is a complement inhibitor that works to prevent the activation of C5, which is a complement protein involved in the innate immune system to initiate inflammatory responses. In October 2023, zilucoplan gained its first FDA approval for the treatment of generalized myasthenia gravis.

Background

Indication

Zilucoplan is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.

Associated Conditions

Generalized Myasthenia Gravis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women	2025/05/08	NCT06961747	Phase 1	Not yet recruiting	UCB Biopharma SRL
Effectiveness and Safety of Zilucoplan Treatment for French Patients with Myasthenia Gravis Over 3 Months	2025/02/07	NCT06815133	N/A	Not yet recruiting	Centre Hospitalier Universitaire de Nice
A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants	2024/07/19	NCT06511076	Phase 1	Completed	UCB Biopharma SRL
A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Gravis	2024/06/24	NCT06471361	Phase 3	Completed	UCB Biopharma SRL
An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis	2024/05/30	NCT06435312	Phase 3	ENROLLING_BY_INVITATION	UCB Biopharma SRL
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis	2023/09/28	NCT06055959	Phase 2	Recruiting	UCB Biopharma SRL
An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors	2022/08/25	NCT05514873	Phase 3	Completed	UCB Biopharma SRL
Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients	2020/10/19	NCT04590586	Phase 3	Completed	Amgen
HEALEY ALS Platform Trial - Regimen A Zilucoplan	2020/06/18	NCT04436497	Phase 2	Completed	Merit E. Cudkowicz, MD
Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure	2020/05/11	NCT04382755	Phase 2	Completed	University Hospital, Ghent

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ZILBRYSQ	UCB, Inc.	50474-991	SUBCUTANEOUS	40 mg in 1 mL	10/23/2023
ZILBRYSQ	UCB, Inc.	50474-990	SUBCUTANEOUS	40 mg in 1 mL	10/23/2023
ZILBRYSQ	UCB, Inc.	50474-992	SUBCUTANEOUS	40 mg in 1 mL	10/23/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Zilbrysq	UCB Pharma S.A.,Allée de la Recherche 60,B-1070 Bruxelles,Belgium	Authorised	12/1/2023

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ZILBRYSQ zilucoplan (as tetrasodium) 32.4 mg/ 0.810 mL solution for injection pre-filled syringe	414649	UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia	Medicine	A	8/20/2024
ZILBRYSQ zilucoplan (as tetrasodium) 23.0 mg/ 0.574 mL solution for injection pre-filled syringe	414648	UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia	Medicine	A	8/20/2024
ZILBRYSQ zilucoplan (as tetrasodium) 16.6 mg/ 0.416 mL solution for injection pre-filled syringe	410994	UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia	Medicine	A	8/20/2024

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