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Pegcetacoplan - Apellis Pharmaceuticals/Swedish Orphan Biovitrum

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Drug Profile

Pegcetacoplan - Apellis Pharmaceuticals/Swedish Orphan Biovitrum

Alternative Names: APL-2; Aspaveli; EMPAVELI; Pegcetacoplan injection - Apellis Pharmaceuticals/Swedish Orphan Biovitrum; SYFOVRE

Latest Information Update: 07 Aug 2025

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At a glance

  • Originator Apellis Pharmaceuticals
  • Developer Apellis Pharmaceuticals; Swedish Orphan Biovitrum
  • Class Anti-inflammatories; Anti-ischaemics; Antianaemics; Antithrombotics; Cyclic peptides; Eye disorder therapies; Polyethylene glycols; Urologics
  • Mechanism of Action Complement C3 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Paroxysmal nocturnal haemoglobinuria; Autoimmune haemolytic anaemia; Glomerulonephritis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Age-related macular degeneration; Paroxysmal nocturnal haemoglobinuria
  • Registered Membranoproliferative glomerulonephritis
  • Phase II Glomerulonephritis; IgA nephropathy; Lupus nephritis; Membranous glomerulonephritis; Thrombotic microangiopathy
  • Phase I/II Wet age-related macular degeneration
  • Discontinued Amyotrophic lateral sclerosis; Autoimmune haemolytic anaemia; Ischaemia

Most Recent Events

  • 31 Jul 2025 Apellis Pharmaceuticals plans phase III trial in focal segmental glomerulosclerosis in 2H 2025
  • 28 Jul 2025 Registered for Membranoproliferative glomerulonephritis (In adults, Treatment-experienced, In adolescents, In the elderly) in USA (SC)
  • 01 Jul 2025 Swedish Orphan Biovitrum announced that an opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) was anticipated before the end of the year

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