Product
Zilucoplan
Aliases
RA101495, zilucoplan (RA101495)
Name
ZILBRYSQ
INN Name
zilucoplan
FDA Approved
Yes
8 clinical trials
1 organization
4 indications
1 document
Indication
Myasthenia GravisIndication
Paroxysmal Nocturnal HemoglobinuriaIndication
Amyotrophic lateral sclerosisIndication
GeneralizedClinical trial
A Phase 3b, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Participants With Generalized Myasthenia Gravis Switching From Intravenous Complement Component 5 Inhibitors to Subcutaneous ZilucoplanStatus: Active (not recruiting), Estimated PCD: 2024-03-13
Clinical trial
A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia GravisStatus: Active (not recruiting), Estimated PCD: 2026-05-20
Clinical trial
A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical StudyStatus: Terminated, Estimated PCD: 2021-09-07
Clinical trial
An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Zilucoplan in Pediatric Study Participants With Acetylcholine Receptor Antibody Positive Generalized Myasthenia GravisStatus: Not yet recruiting, Estimated PCD: 2027-10-26
Clinical trial
HEALEY ALS Platform Trial - Regimen A ZilucoplanStatus: Completed, Estimated PCD: 2022-04-13
Clinical trial
A Multicenter Open-Label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Activity of Zilucoplan in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Acetylcholine Receptor Antibody Positive Generalized Myasthenia GravisStatus: Recruiting, Estimated PCD: 2026-10-26
Clinical trial
A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisStatus: Completed, Estimated PCD: 2021-12-30
Clinical trial
A Multicenter, Open-Label, Outpatient Study to Evaluate the Safe And Effective Use of a Zilucoplan Auto-Injector Combination Product for Subcutaneous Self-Administration by Study Participants With Generalized Myasthenia GravisStatus: Not yet recruiting, Estimated PCD: 2024-12-16
Document
DailyMed Label: ZILBRYSQOrganization
UCB, Inc.