Zilbrysq

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Amyotrophic Lateral SclerosisGeneralized Myasthenia GravisGeneralized Myasthenia Gravis (gmg)

55 competitors in Amyotrophic Lateral Sclerosis

#DrugCompanyPhaseTrials

1

Vimpat

UCB

Approved

—2

Nourianz

Kyowa Kirin Co., Ltd.

Approved

—3

Enablex

AbbVie

Approved

—4

Bosulif

PPrism Pharmaceuticals

Approved

15

Qalsody

Biogen

Approved

36

Avodart

Akero Therapeutics

Approved

—7

Quinidine Gluconate

WWyeth-Lederle Vaccines

Approved

—8

Mirapex

Boehringer Ingelheim

Approved

—9

Transderm Scop

BBaxter Healthcare Corporation

Approved

—10

Rapamune

PPrism Pharmaceuticals

Approved

—Show 29 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

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

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

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

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

Show 1 more trial

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

Generalized Myasthenia Gravis3 trials

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

Completed·UCB·Phase 3·NCT04225871·200 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

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

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

Trial1 trial

HEALEY ALS Platform Trial - Regimen A Zilucoplan

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

7 more indications

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

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

COVID-191 trial

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

Completed·Amgen·Phase 3·NCT04590586·515 enrolled

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

Generalized Myasthenia Gravis (gMG)1 trial

Zilucoplan Treatment of Severe MG Exacerbations Leading to Hospitalization of Participants With Acetylcholine Receptor Antibody Positive gMG

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

Amyotrophic Lateral Sclerosis1 trial

HEALEY ALS Platform Trial

Active, not recruiting·MMerit E. Cudkowicz, MD·Preclinical·NCT04297683·1,500 enrolled

Unspecified1 trial

An Open-Label, Repeated-Dose Assessment of Zilucoplan Concentration in Breast Milk of Healthy Lactating Women

Recruiting·UCB·Phase 1·NCT06961747·15 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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