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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: 11 Apr 2024

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

Highest Development Phases

  • Marketed Immunodeficiency disorders
  • Discontinued Sjogren's syndrome

Most Recent Events

  • 08 Apr 2024 Pharming NV plans to submit regulatory filings for approval of Leniolisib for the treatment of Immunodeficiency disorders (In adolescents, In adults) Worldwide, beginning in 2025
  • 08 Apr 2024 Pharming Group completes enrolment in phase III trials in Immunodeficiency disorders (In children) in USA, France, Japan and Netherlands (PO) (NCT05438407) (EudraCT2022-001624-14)
  • 14 Mar 2024 Pharming Group NV plans to launch leniolisib for Immunodeficiency disorders (In children, In Adolescents, In Adults) (PO) in the U.K., Asia Pacific, Middle East, and Canada
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