EMPAVELI

Peak

pegcetacoplan

NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Complement Inhibitors

Pharmacologic Class:

Complement Inhibitor

Clinical Trials (5)

NCT07020832Phase 3Recruiting

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation

Started Feb 2026
320 enrolled
Delayed Graft FunctionEnd Stage Renal DiseaseDeceased Donor Kidney Transplant
NCT07214740Phase 3Completed

Study to Evaluate a Pegcetacoplan (Syfovre®) Prefilled Syringe

Started Oct 2025
44 enrolled
Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT07215390Phase 2Recruiting

A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneratio

Started Jun 2025
240 enrolled
Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT06161584N/AActive Not Recruiting

A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Started Sep 2023
300 enrolled
Geographic Atrophy
NCT05776472N/ARecruiting

A Real World Effectiveness Study of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Started Jun 2023

Loss of Exclusivity

LOE Date
Dec 14, 2038
155 months away
Patent Expiry
Dec 14, 2038
Exclusivity Expiry
Jul 28, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
9169307
Nov 18, 2027
Substance
U-3123
7888323
Dec 4, 2027
Substance
7989589
Dec 4, 2027
Substance
11661441
Jan 13, 2033
Substance
U-3124
10125171
Aug 2, 2033
Substance