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leniolisib

Generic: LENIOLISIB PHOSPHATE·Brand: JOENJA, Joenja

leniolisib: 3 clinical trials tracked.

leniolisib evidence translation

What we can confirm

3 tracked trials

No verified listed company relationship

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about leniolisib, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

Clinical Trial Registry Records (3)

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Leniolisib for Immune Dysregulation in Primary Immunodeficiency Disorders

NCT06990529Registry updated 2026-09-16·Phase 2
Active, not recruiting

Primary endpoint: To assess the long-term safety and tolerability of leniolisib

Interventionalopen12 targetStarted 2025-04Completion 2029-085 sites · Spain, United Kingdom, United StatesPharming Technologies B.V.

An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 1 to 6 Years) With APDS (Activated Phosphoinositide 3-Kinase Delta Syndrome) Followed by an Open-label Long-term Extension

NCT05693129Registry updated 2026-06-15·Phase 3
Active, not recruiting

Primary endpoint: Part I & II: Number of Participants with Treatment-emergent adverse events (TEAEs), Serious Adverse Events (SAEs) , and Adverse Events (AEs)

Interventionalopen16 enrolledStarted 2023-08Completion 2028-109 sites · Japan, Portugal, Spain, United Kingdom…Pharming Technologies B.V.

An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients Aged 4 to 11 Years With Activated Phosphoinositide 3-Kinase Delta Syndrome Followed by an Open-label Long-term Extension

NCT05438407Registry updated 2026-05-06·Phase 3
Active, not recruiting

Primary endpoint: Part I & II: Number of Participants with Treatment-emergent adverse events (TEAEs), Serious Adverse Events (SAEs) , and Adverse Events (AEs)

Interventionalopen15 targetStarted 2023-02Completion 2026-127 sites · France, Japan, United StatesPharming Technologies B.V.