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Zilucoplan updates

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4 changes for Zilucoplan in the last 12 months. Latest: 2026-03-27.

DateTypeWhat changedSource
2026-03-27ResultsResults posted: A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia GravisTrial register ClinicalTrials.gov
2026-02-03LabelFDA label revised: ZILBRYSQ (NDA216834)Regulator FDA drug label register
2026-01-06ResultsResults posted: A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult ParticipantsTrial register ClinicalTrials.gov
2025-10-14TrialNew trial registered: Zilucoplan for Severe gMG ExacerbationsTrial register ClinicalTrials.gov
2025-06-20Federal RegisterFederal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; ZILBRYSQRegulator Federal Register
2025-05-21Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2025-05-08TrialNew trial registered: A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating WomenTrial register ClinicalTrials.gov
2025-03-30ResultsResults posted: An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who WTrial register ClinicalTrials.gov
2025-02-07TrialNew trial registered: Effectiveness and Safety of Zilucoplan Treatment for French Patients With Myasthenia Gravis Over 3 MonthsTrial register ClinicalTrials.gov
2024-07-19TrialNew trial registered: A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult ParticipantsTrial register ClinicalTrials.gov
2024-06-24TrialNew trial registered: A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia GravisTrial register ClinicalTrials.gov
2024-05-30TrialNew trial registered: An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia GravisTrial register ClinicalTrials.gov
2023-09-28TrialNew trial registered: A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia GravisTrial register ClinicalTrials.gov
2023-09-14ResultsResults posted: Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory FailureTrial register ClinicalTrials.gov
2023-07-25ResultsResults posted: HEALEY ALS Platform Trial - Regimen A ZilucoplanTrial register ClinicalTrials.gov
2023-01-17ResultsResults posted: Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisTrial register ClinicalTrials.gov
2022-10-27ResultsResults posted: Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical StudyTrial register ClinicalTrials.gov
2022-08-25TrialNew trial registered: An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia GravisTrial register ClinicalTrials.gov
2022-06-29ResultsResults posted: Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized PatientsTrial register ClinicalTrials.gov
2022-06-27ResultsResults posted: Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia GravisTrial register ClinicalTrials.gov
2022-05-16ResultsResults posted: Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing MyopathyTrial register ClinicalTrials.gov
2020-10-19TrialNew trial registered: Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized PatientsTrial register ClinicalTrials.gov
2020-06-18TrialNew trial registered: HEALEY ALS Platform Trial - Regimen A ZilucoplanTrial register ClinicalTrials.gov
2020-05-11TrialNew trial registered: Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory FailureTrial register ClinicalTrials.gov
2020-03-10ResultsResults posted: Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH PatientsTrial register ClinicalTrials.gov
2020-03-05TrialNew trial registered: HEALEY ALS Platform Trial - Master ProtocolTrial register ClinicalTrials.gov
2020-02-26ResultsResults posted: Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to EculizumabTrial register ClinicalTrials.gov
2020-01-13TrialNew trial registered: Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia GravisTrial register ClinicalTrials.gov
2019-10-04TrialNew trial registered: Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisTrial register ClinicalTrials.gov
2019-07-19TrialNew trial registered: Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing MyopathyTrial register ClinicalTrials.gov
2017-10-19TrialNew trial registered: Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia GravisTrial register ClinicalTrials.gov
2017-07-21TrialNew trial registered: Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical StudyTrial register ClinicalTrials.gov
2017-03-13TrialNew trial registered: Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH PatientsTrial register ClinicalTrials.gov
2017-01-24TrialNew trial registered: Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to EculizumabTrial register ClinicalTrials.gov

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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