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PI3Kδ inhibitor

Leniolisib

Brand names: Joenja

Leniolisib is an oral selective PI3K-delta inhibitor used to treat activated PI3K-delta syndrome (APDS), a rare inborn error of immunity. It is taken under specialist immunology supervision.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It selectively inhibits the p110-delta catalytic subunit of phosphoinositide 3-kinase delta, counteracting the overactive PI3K-delta signalling that causes APDS.

Prescribing in practice

  • Use is restricted to patients with a genetically confirmed diagnosis of activated PI3K-delta syndrome.
  • It is a CYP3A4 substrate, so avoid strong inducers and inhibitors of CYP3A4 where possible.
  • Routine immune and haematological assessment of this complex immunodeficiency continues alongside treatment.

Monitoring

Monitor full blood count and clinical features of the underlying immunodeficiency, including lymphadenopathy and infections.

Counselling the patient

  • Take the tablets as directed and do not stop without specialist advice.
  • Avoid grapefruit and tell the team about all other medicines.
  • Continue to report infections and attend immunology follow-up.

Evidence & guidelines

Leniolisib improved immunological and clinical measures in a randomised placebo-controlled trial in activated PI3K-delta syndrome.

Reference: SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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