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Iptacopan - Novartis Pharmaceuticals

Drug Profile

Iptacopan - Novartis Pharmaceuticals

Alternative Names: FABHALTA; Iptacopan hydrochloride monohydrate - Novartis Pharmaceuticals; LNP 023; LNP023-AAB; NVP-LNP023; NVP-LNP023-AAB; NVP-LNP023-NX

Latest Information Update: 31 May 2024

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At a glance

  • Originator Novartis Pharmaceuticals
  • Class Anti-inflammatories; Antianaemics; Benzoic acids; Ethers; Eye disorder therapies; Indoles; Piperidines; Small molecules; Urologics
  • Mechanism of Action Complement factor B 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; Membranoproliferative glomerulonephritis; IgA nephropathy
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Paroxysmal nocturnal haemoglobinuria
  • Preregistration IgA nephropathy
  • Phase III Atypical Haemolytic Uraemic Syndrome; Membranoproliferative glomerulonephritis
  • Phase II Age-related macular degeneration; Autoimmune haemolytic anaemia; Idiopathic thrombocytopenic purpura; Lupus nephritis; Membranous glomerulonephritis

Most Recent Events

  • 25 May 2024 Efficacy data from a phase III APPEAR-C3G trial in membranoproliferative glomerulonephritis released by Novartis Pharmaceuticals
  • 13 May 2024 Phase-III clinical trials in Membranoproliferative glomerulonephritis (In children, In adolescents) (PO), before May 2024 (Novartis pipeline, May 2024)
  • 29 Apr 2024 Novartis Pharmaceuticals plans a phase II trial for Vasculitis () in August 2024 (NCT06388941)
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