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Leniolisib - Pharming Group NV

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Drug Profile

Leniolisib - Pharming Group NV

Alternative Names: CDZ-173; Joenja

Latest Information Update: 07 Aug 2025

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At a glance

  • Originator Novartis
  • Developer Novartis; Pharming Group NV
  • Class Amines; Ethers; Fluorinated hydrocarbons; Ketones; Pyridines; Pyrimidines; Pyrrolidines; Small molecules
  • Mechanism of Action Phosphatidylinositol 3 kinase delta inhibitors
  • Orphan Drug Status

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

    Yes - Immunodeficiency disorders; Immunological disorders
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Immunodeficiency disorders
  • Phase II Common variable immunodeficiency
  • Discontinued Sjogren's syndrome

Most Recent Events

  • 31 Jul 2025 Pharming Group anticipates approval from Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for leniolisib for the treatment of APDS in adult and pediatric patients 4 years of age and older in March 2026
  • 31 Jul 2025 Pharming Group expects approval from the US FDA for leniolisib for the treatment of children aged 4 to 11 years diagnosed with activated PI3Kdelta syndrome in the first half of 2026
  • 30 Jun 2025 Preregistration for Immunodeficiency disorders (In children, In adolescents, In adults) in Japan (PO)

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