Pegcetacoplan is under clinical development by Apellis Pharmaceuticals and currently in Phase III for Membranoproliferative Glomerulonephritis (Mesangiocapillary Glomerulonephritis). According to GlobalData, Phase III drugs for Membranoproliferative Glomerulonephritis (Mesangiocapillary Glomerulonephritis) does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Pegcetacoplan LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Pegcetacoplan overview

Pegcetacoplan (Empaveli, Aspaveli) is a synthetic peptide acts as a complement inhibitor. It is formulated as injectable solution for subcutaneous route of administration. Empaveli is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), Aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months.

Pegcetacoplan (APL-2) is under development for the treatment of post-transplant recurrence of C3G or IC-MPGN, transplant-associated thrombotic microangiopathy (TA-TMA), IgA nephropathy (Berger's disease), lupus nephritis, primary membranous nephropathy, or C3 glomerulopathy (Kidney Disease (Nephropathy)) includes C3 glomerulonephritis, paroxysmal nocturnal hemoglobinuria (PNH)  or cold agglutinin disease(wAIHA). It is a  synthetic cyclic peptide conjugated to a polyethylene glycol (PEG) polymer. It is administered subcutaneously as an infusion for PNH and intravitreally for AMD. It is a compstatin derivative and a long-acting small cyclic peptide that targets complement factor C3. It was also under development for the treatment of kidney transplant rejection, refractory myasthenia gravis and neuromyelitis optica, neovascular age-related macular degeneration (AMD).

It was also under development for the treatment of amyotrophic lateral sclerosis (ALS) and geographic atrophy, autoimmune hemolytic anemia.

Apellis Pharmaceuticals overview

Apellis Pharmaceuticals (Apellis) is a clinical-stage biopharmaceutical company that focuses on the discovery and development of therapeutic compounds for autoimmune and inflammatory diseases through inhibition of the complement system at the level of C3 (central protein). Its pipeline product portfolio includes EMPAVELI pegcetacoplan injection for paroxysmal nocturnal hemoglobinuria disease and SYFOVRE intravitreal pegcetacoplan injection for Geographic Atrophy. Its other products include APL-1030, APL-2006 and Orala Alternative Pathway Inhibitor, among others. The company conducts research on chronic therapy with a C3 inhibitor into clinical trialsIt operates in Australia, Bermuda, the US, Germany, France, Ireland, the Netherlands, Switzerland, the UK nad Cayman Islands. Apellis is headquartered in Waltham, Massachusetts, the US.

For a complete picture of Pegcetacoplan’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.