Zilucoplan
- Generic Name
- Zilucoplan
- Brand Names
- Zilbrysq
- Drug Type
- Small Molecule
- Chemical Formula
- C172H278N24O55
- 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
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
- First Posted Date
- 2025-05-08
- Last Posted Date
- 2025-05-08
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 15
- Registration Number
- NCT06961747
Effectiveness and Safety of Zilucoplan Treatment for French Patients with Myasthenia Gravis Over 3 Months
- First Posted Date
- 2025-02-07
- Last Posted Date
- 2025-02-07
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Target Recruit Count
- 55
- Registration Number
- NCT06815133
- Locations
- 🇫🇷
CHU NICE, Nice, Alpes Maritimes, France
A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants
- 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
- First Posted Date
- 2024-06-24
- Last Posted Date
- 2025-02-17
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 31
- Registration Number
- NCT06471361
- Locations
- 🇺🇸
Dv0013 50628, New Haven, Connecticut, United States
🇺🇸Dv0013 50634, Tampa, Florida, United States
🇺🇸Dv0013 50556, Chapel Hill, North Carolina, United States
An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
- First Posted Date
- 2024-05-30
- Last Posted Date
- 2025-03-13
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 8
- Registration Number
- NCT06435312
- Locations
- 🇬🇧
Mg0015 40736, London, United Kingdom
🇺🇸Mg0015 50168, Chicago, Illinois, United States
🇺🇸Mg0015 50574, Denton, Texas, United States
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
- First Posted Date
- 2023-09-28
- Last Posted Date
- 2025-03-13
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 8
- Registration Number
- NCT06055959
- Locations
- 🇬🇧
Mg0014 40736, London, United Kingdom
🇰🇷Mg0014 20220, Seoul, Korea, Republic of
🇺🇸Mg0014 50168, Chicago, Illinois, United States
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
- First Posted Date
- 2022-08-25
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 26
- Registration Number
- NCT05514873
- Locations
- 🇺🇸
Mg0017 50593, Rancho Mirage, California, United States
🇺🇸Mg0017 50304, Dallas, Texas, United States
🇺🇸Mg0017 50086, Charlotte, North Carolina, United States
Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients
- Conditions
- COVID-19
- Interventions
- 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
HEALEY ALS Platform Trial - Regimen A Zilucoplan
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Drug: Matching Placebo
- 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
Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure
- First Posted Date
- 2020-05-11
- Last Posted Date
- 2023-09-14
- Lead Sponsor
- University Hospital, Ghent
- Target Recruit Count
- 81
- Registration Number
- NCT04382755
- Locations
- 🇧🇪
OLVZ Aalst, Aalst, Belgium
🇧🇪Erasmus University Hospital, Brussels, Belgium
🇧🇪AZ Sint-Lucas, Gent, Belgium
Drug Development Updates
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