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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: 24 May 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

  • 08 May 2025 Registered for Immunodeficiency disorders (In adults, In adolescents, In the elderly) in Australia (PO)
  • 08 May 2025 Pharming Group announces intention to launch Leniolisib for Immunological disorders (In children) in first quarter of 2026 (PO)
  • 08 May 2025 Pharming Group announces intention to submit regulatory filing to US FDA for immunological disorders (In children) in Q3 2025 (PO (9442059)

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