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
Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis
- Conditions
- Generalized Myasthenia Gravis
- Interventions
- First Posted Date
- 2020-01-13
- Last Posted Date
- 2025-04-25
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 200
- Registration Number
- NCT04225871
- Locations
- 🇺🇸
Mg0011 41, Mobile, Alabama, United States
🇺🇸Mg0011 116, Phoenix, Arizona, United States
🇺🇸Mg0011 31, Irvine, California, United States
Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
- Conditions
- Myasthenia Gravis, Generalized
- Interventions
- Drug: Placebo
- First Posted Date
- 2019-10-04
- Last Posted Date
- 2024-10-14
- Lead Sponsor
- Ra Pharmaceuticals, Inc.
- Target Recruit Count
- 174
- Registration Number
- NCT04115293
- Locations
- 🇺🇸
Site 4: University of Southern California, Los Angeles, California, United States
🇺🇸Site 188: North Shore Medical Group - Glenview, Glenview, Illinois, United States
🇺🇸Site 123: Northwell Health Neuroscience Institute, Great Neck, New York, United States
Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
- Conditions
- Immune Mediated Necrotizing Myopathy
- Interventions
- Other: Placebo
- 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
Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
- Conditions
- Generalized Myasthenia Gravis
- Interventions
- Drug: Placebo
- First Posted Date
- 2017-10-19
- Last Posted Date
- 2022-07-27
- Lead Sponsor
- Ra Pharmaceuticals
- Target Recruit Count
- 45
- Registration Number
- NCT03315130
- Locations
- 🇺🇸
University of Florida, Jacksonville, Florida, United States
🇺🇸Michigan State University, East Lansing, Michigan, United States
🇨🇦University of Alberta Hospital, Edmonton, Alberta, Canada
Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Interventions
- First Posted Date
- 2017-07-21
- Last Posted Date
- 2023-09-28
- Lead Sponsor
- Ra Pharmaceuticals, Inc.
- Target Recruit Count
- 19
- Registration Number
- NCT03225287
- Locations
- 🇫🇮
Investigative Site 14, Helsinki, Finland
🇺🇸Investigative Site 4, Los Angeles, California, United States
🇺🇸Investigative Site 19, Dallas, Texas, United States
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Interventions
- First Posted Date
- 2017-03-13
- Last Posted Date
- 2022-07-27
- Lead Sponsor
- Ra Pharmaceuticals
- Target Recruit Count
- 26
- Registration Number
- NCT03078582
- Locations
- 🇬🇧
Investigative Site, London, United Kingdom
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Interventions
- First Posted Date
- 2017-01-24
- Last Posted Date
- 2022-07-27
- Lead Sponsor
- Ra Pharmaceuticals
- Target Recruit Count
- 3
- Registration Number
- NCT03030183
- Locations
- 🇺🇸
Investigative Site, Dallas, Texas, United States
Drug Development Updates
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