Zilucoplan

Generic Name: Zilucoplan

Brand Names: Zilbrysq

Drug Type: Small Molecule

Chemical Formula: C_₁₇₂H_₂₇₈N_₂₄O_₅₅

CAS Number: 1841136-73-9

Unique Ingredient Identifier: YG391PK0CC

Background: 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.

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

Associated Therapies: -

Clinical Trials

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

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Zilucoplan

First Posted Date: 2024-07-19

Last Posted Date: 2024-12-06

Lead Sponsor: UCB Biopharma SRL

Target Recruit Count: 14

Registration Number: NCT06511076

Locations: 🇳🇱
DV0012 1, Groningen, Netherlands

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

Phase 3

Recruiting

Conditions: Generalized Myasthenia Gravis

Interventions: Drug: Zilucoplan

First Posted Date: 2024-06-24

Last Posted Date: 2024-12-06

Lead Sponsor: UCB Biopharma SRL

Target Recruit Count: 25

Registration Number: NCT06471361

Locations: 🇬🇧
Dv0013 40760, Oxford, United Kingdom
🇺🇸
Dv0013 50628, New Haven, Connecticut, United States
🇺🇸
Dv0013 50634, Tampa, Florida, United States

and more 8 locations

An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

Phase 3

Conditions: Generalized Myasthenia Gravis

Interventions: Drug: Zilucoplan

First Posted Date: 2024-05-30

Last Posted Date: 2024-12-03

Lead Sponsor: UCB Biopharma SRL

Target Recruit Count: 8

Registration Number: NCT06435312

Locations: 🇺🇸
Mg0015 50574, Denton, Texas, United States
🇮🇹
Mg0015 40144, Milano, Italy
🇰🇷
Mg0015 20104, Seoul, Korea, Republic of

and more 2 locations

A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

Phase 2

Recruiting

Conditions: Generalized Myasthenia Gravis

Interventions: Drug: Zilucoplan

First Posted Date: 2023-09-28

Last Posted Date: 2024-11-22

Lead Sponsor: UCB Biopharma SRL

Target Recruit Count: 8

Registration Number: NCT06055959

Locations: 🇺🇸
Mg0014 50168, Chicago, Illinois, United States
🇺🇸
Mg0014 50574, Denton, Texas, United States
🇮🇹
Mg0014 40144, Milano, Italy

and more 3 locations

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

Phase 3

Completed

Conditions: COVID-19

Interventions: Drug: Standard of care
Drug: Apremilast placebo
Drug: Lanadelumab placebo
Drug: Zilucoplan placebo
Drug: Lanadelumab
Drug: Apremilast
Drug: Zilucoplan

First Posted Date: 2020-10-19

Last Posted Date: 2022-06-29

Lead Sponsor: Amgen

Target Recruit Count: 515

Registration Number: NCT04590586

Locations: 🇺🇸
The University of Iowa, Iowa City, Iowa, United States
🇺🇸
Sharp Chula Vista Medical Center, Chula Vista, California, United States
🇷🇺
SPb SBIH "Alexandrovskaya City Hospital", Saint Petersburg, Russian Federation

and more 56 locations

HEALEY ALS Platform Trial - Regimen A Zilucoplan

Phase 2

Completed

Conditions: Amyotrophic Lateral Sclerosis

Interventions: Drug: Matching Placebo
Drug: Zilucoplan

First Posted Date: 2020-06-18

Last Posted Date: 2023-07-25

Lead Sponsor: Merit E. Cudkowicz, MD

Target Recruit Count: 162

Registration Number: NCT04436497

Locations: 🇺🇸
Healey Center for ALS at Mass General, Boston, Massachusetts, United States

HEALEY ALS Platform Trial - Master Protocol

Phase 2

Active, not recruiting

Conditions: Amyotrophic Lateral Sclerosis

Interventions: Drug: SLS-005 Trehalose
Drug: Zilucoplan
Drug: Verdiperstat
Drug: Pridopidine
Drug: CNM-Au8
Drug: ABBV-CLS-7262
Drug: DNL343

First Posted Date: 2020-03-05

Last Posted Date: 2024-06-27

Lead Sponsor: Merit E. Cudkowicz, MD

Target Recruit Count: 1500

Registration Number: NCT04297683

Locations: 🇺🇸
Neurology Associates, P.C./Somnos Clinical Research, Lincoln, Nebraska, United States
🇺🇸
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

and more 73 locations

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

Phase 2

Terminated

Conditions: Immune Mediated Necrotizing Myopathy

Interventions: Other: Placebo
Drug: zilucoplan

First Posted Date: 2019-07-19

Last Posted Date: 2022-07-27

Lead Sponsor: Ra Pharmaceuticals

Target Recruit Count: 27

Registration Number: NCT04025632

Locations: 🇺🇸
University of California Los Angeles, Los Angeles, California, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
The Ohio State University, Columbus, Ohio, United States

and more 15 locations

Drug Development Updates

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