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An Open-label, Non-randomized, Within-patient Dose-finding Study Followed by a Randomized, Subject, Investigator and Sponsor Blinded Placebo Controlled Study to Assess the Efficacy and Safety of CDZ173 (Leniolisib) in Patients With APDS/PASLI (Activated Phosphoinositide 3-kinase Delta Syndrome/ p110δ-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency)

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Trial Profile

An Open-label, Non-randomized, Within-patient Dose-finding Study Followed by a Randomized, Subject, Investigator and Sponsor Blinded Placebo Controlled Study to Assess the Efficacy and Safety of CDZ173 (Leniolisib) in Patients With APDS/PASLI (Activated Phosphoinositide 3-kinase Delta Syndrome/ p110δ-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency)

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 11 Jun 2026

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At a glance

  • Drugs Leniolisib (Primary)
  • Indications Common variable immunodeficiency; Immunodeficiency disorders; Lymphadenopathy
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Novartis; Novartis Pharmaceuticals

Most Recent Events

  • 23 May 2026 According to Pharming Group NV media release, based on this trial data, the European Commission (EC) has granted marketing authorization for Joenja (leniolisib), an oral, selective phosphoinositide 3-kinase (PI3K) delta inhibitor, for the treatment of activated PI3K delta syndrome in adult and pediatric patients 12 years of age and older. The first European launch is expected in Germany in Q3 2026.
  • 07 May 2026 According to Pharming Group NV media release, A final decision by the European Commission (EC) on the marketing authorization is expected in the second quarter of 2026. If approved, Joenja would become the first approved treatment for APDS in the European Union. The centralized marketing authorization would be valid in all 27 European Union Member States, as well as Norway, Iceland and Liechtenstein.
  • 27 Mar 2026 According to an European Medicines Agency media release, Joenja (leniolisib) received a positive opinion for a marketing authorisation under exceptional circumstances for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more.

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