Zilbrysq

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

COVID-19Myasthenia GravisRespiratory FailureMyopathyGeneralized Myasthenia Gravis

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

1

Zilbrysq

UCB

Phase 3

12

Biaxin

AbbVie

Preclinical

23

Singulair

AstraZeneca

Preclinical

14

Activella

Eli Lilly

Preclinical

—5

Angiomax

BBaxter Healthcare Corporation

Preclinical

26

Nitrostat

VViatris Specialty LLC

Preclinical

17

Low-Molecular-Weight Heparin

Daiichi Sankyo

Preclinical

38

Orap

Teva

Preclinical

19

Blood Taken

HHospices Civils de Lyon

Preclinical

110

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1Show 13 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Myasthenia Gravis4 trials

A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Gravis

Completed·UCB·Phase 3·NCT06471361·31 enrolled

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

Completed·UCB·Phase 3·NCT05514873·26 enrolled

Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

Completed·RRa Pharmaceuticals·Phase 2·NCT03315130·45 enrolled

Show 1 more trial

Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis

Completed·RRa Pharmaceuticals·Phase 3·NCT04115293·174 enrolled

Generalized Myasthenia Gravis3 trials

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 Gravis

Enrolling by invitation·UCB·Phase 3·NCT06435312·8 enrolled

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 Gravis

Recruiting·UCB·Preclinical·NCT06055959·8 enrolled

A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis

Active, not recruiting·UCB·Phase 3·NCT04225871·200 enrolled

Trial2 trials

HEALEY ALS Platform Trial - Regimen A Zilucoplan

Completed·MMerit E. Cudkowicz, MD·Phase 2/3·NCT04436497·162 enrolled

HEALEY ALS Platform Trial - Master Protocol

Recruiting·MMerit E. Cudkowicz, MD·Phase 2/3·NCT04297683·1,500 enrolled

Safety and Efficacy2 trials

Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab

Completed·RRa Pharmaceuticals·Phase 2·NCT03030183·3 enrolled

Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients

Completed·RRa Pharmaceuticals·Phase 2·NCT03078582·26 enrolled

Myopathy1 trial

Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy

Terminated·RRa Pharmaceuticals·Phase 2·NCT04025632·27 enrolled

6 more indications

Respiratory Failure1 trial

Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure

Completed·UUniversity Hospital, Ghent·Phase 2·NCT04382755·81 enrolled

Adult1 trial

A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants

Completed·UCB·Phase 1·NCT06511076·14 enrolled

Concentration1 trial

A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women

Recruiting·UCB·Phase 1·NCT06961747·15 enrolled

gMG1 trial

Zilucoplan for Severe gMG Exacerbations

Recruiting·MMiriam Freimer·Phase 3·NCT07215949·15 enrolled

COVID-191 trial

Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients

Completed·Amgen·Phase 3·NCT04590586·515 enrolled

PNH1 trial

Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study

Terminated·RRa Pharmaceuticals·Phase 2·NCT03225287·19 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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