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Iptacopan - Novartis Pharmaceuticals

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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: 29 Oct 2025

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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; Vascular disorder therapies
  • 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; IgA nephropathy; Membranoproliferative glomerulonephritis
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 16 Oct 2025 Registered for Membranoproliferative glomerulonephritis in Japan (PO) prior to October 2025
  • 16 Oct 2025 Novartis announces intention to submit regulatory application to the US FDA for IgA nephropathy in 2026
  • 16 Oct 2025 Efficacy data from phase III APPLAUSE-IgAN trial in IgA nephropathy released by Novartis

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