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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: 01 Jul 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; IgA nephropathy; Membranoproliferative glomerulonephritis
  • 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; Lupus nephritis; Membranous glomerulonephritis
  • Discontinued Autoimmune haemolytic anaemia; Idiopathic thrombocytopenic purpura

Most Recent Events

  • 24 Jun 2024 Registered for Paroxysmal nocturnal haemoglobinuria in Japan (PO)
  • 18 Jun 2024 Discontinued - Phase-II for Autoimmune haemolytic anaemia (Treatment-experienced) in Germany, Spain, United Kingdom, Italy, South Korea, USA (PO) prior to June 2024 (Novartis pipeline, June 2024)
  • 18 Jun 2024 Discontinued - Phase-II for Idiopathic thrombocytopenic purpura (Treatment-experienced) in Germany, Spain, United Kingdom, USA, Italy, South Korea (PO) prior to June 2024 (Novartis pipeline, June 2024)
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