Pegcetacoplan
- Generic Name
- Pegcetacoplan
- Brand Names
- Empaveli, Syfovre, Aspaveli
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 2019171-69-6
- Unique Ingredient Identifier
- TO3JYR3BOU
- Background
Pegcetacoplan is a complement inhibitor indicated in the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Prior to its FDA approval, patients with PNH were typically treated with the C5 inhibiting monoclonal antibody eculizumab. Patients given eculizumab experienced less hemolysis caused by the membrane attack complex, but were still somewhat suscepti...
- Indication
Pegcetacoplan is indicated to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). It is also indicated to treat geographic atrophy (GA) secondary to age-related macular degeneration.
- Associated Conditions
- Geographic Atrophy Secondary to Age-related Macular Degeneration, Paroxysmal Nocturnal Haemoglobinuria (PNH)
- Associated Therapies
- -
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
- Conditions
- Renal TransplantDense Deposit Disease (DDD)Membranoproliferative Glomerulonephritis (MPGN)Complement 3 GlomerulonephritisMembranoproliferative GlomerulonephritisC3 GlomerulonephritisC3GComplement 3 GlomerulopathyComplement 3 Glomerulopathy (C3G)Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
- Interventions
- First Posted Date
- 2020-10-01
- Last Posted Date
- 2024-03-06
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Target Recruit Count
- 13
- Registration Number
- NCT04572854
- Locations
- 🇮🇹
Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Ranica, Italy
🇺🇸Children's Hospital Colorado, Aurora, Colorado, United States
🇺🇸Mayo Clinic Arizona, Phoenix, Arizona, United States
A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL-2) in Subjects With PNH
- First Posted Date
- 2018-07-20
- Last Posted Date
- 2020-12-22
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Target Recruit Count
- 4
- Registration Number
- NCT03593200
- Locations
- 🇧🇬
Acibadem City Clinic MHAT Tokuda EAD Sofia, Sofia, Bulgaria
🇷🇸Klinički centar Srbije, Belgrade, Serbia
🇧🇬Specialized Hospital for Active Treatment of Hematologic Diseases EAD, Sofia, Sofia, Bulgaria
Pegcetacoplan Long Term Safety and Efficacy Extension Study
- First Posted Date
- 2018-05-21
- Last Posted Date
- 2023-07-03
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Target Recruit Count
- 160
- Registration Number
- NCT03531255
- Locations
- 🇧🇬
Acibadem City Clinic Tokuda Hospital, Sofia, Bulgaria
🇺🇸Baptist Cancer Center, Memphis, Tennessee, United States
🇯🇵Japanese Red Cross Nagoya Daini Hospital, Showa-ku, Aichi, Japan
Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Conditions
- Interventions
- First Posted Date
- 2018-04-18
- Last Posted Date
- 2022-03-25
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Target Recruit Count
- 80
- Registration Number
- NCT03500549
- Locations
- 🇫🇷
Centre Hospitalier de Saint-Quentin, Saint-Quentin, France
🇺🇸Cancer Specialists of North Florida, Jacksonville, Florida, United States
🇺🇸Cancer & Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Pegcetacoplan (APL-2) in Neovascular AMD
- Conditions
- Interventions
- First Posted Date
- 2018-03-14
- Last Posted Date
- 2020-09-16
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Target Recruit Count
- 17
- Registration Number
- NCT03465709
- Locations
- 🇺🇸
Apellis Clinical Site, Houston, Texas, United States
Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. Pegcetacoplan (APL-2) in PNH Subjects.
- First Posted Date
- 2015-10-28
- Last Posted Date
- 2021-01-11
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Target Recruit Count
- 23
- Registration Number
- NCT02588833
- Locations
- 🇳🇿
Waikato Hospital, Hamilton, Waikato, New Zealand
🇲🇾Hospital Ampang, Ampang, Selangor, Malaysia
🇹🇭Ramathibodi Hospital, Bangkok, Thailand
Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy
- First Posted Date
- 2015-07-20
- Last Posted Date
- 2020-10-06
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Target Recruit Count
- 246
- Registration Number
- NCT02503332
- Locations
- 🇺🇸
The Gavin Herbert Eye Institute/UC Irvine, Irvine, California, United States
🇺🇸University of Southern California - USC Eye Institute, Los Angeles, California, United States
🇺🇸Associated Retinal Consultants, PC, Traverse City, Michigan, United States
Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD
- Conditions
- Interventions
- First Posted Date
- 2015-06-03
- Last Posted Date
- 2020-10-06
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Target Recruit Count
- 13
- Registration Number
- NCT02461771
- Locations
- 🇺🇸
United States, Florida, Miami, Florida, United States
🇺🇸United States, California, Beverly Hills, California, United States
🇦🇺Australia, New South Wells, Parramatta, New South Wales, Australia
A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH
- First Posted Date
- 2014-10-15
- Last Posted Date
- 2021-01-08
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Target Recruit Count
- 9
- Registration Number
- NCT02264639
- Locations
- 🇺🇸
University of Southern California Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸Lakes Research, Miami Lakes, Florida, United States
🇺🇸Cleveland Clinic, Cleveland, Ohio, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.