Leniolisib

DRUG6 trials

Sponsors

Pharming Technologies B.V.

Conditions

APDSAPDS Gene MutationCommon Variable Immunodeficiency (CVID)PIDs Linked to PI3KPrimary Immunodeficiency Disorders (PIDs)

Phase 2

Leniolisib for Immune Dysregulation in PIDs

Active, not recruitingNCT06549114

Pharming Technologies B.V.Primary Immunodeficiency Disorders (PIDs)

Start: 2024-10-21End: 2026-11-01Target: 12Updated: 2026-02-13

Leniolisib for Immune Dysregulation in CVID

Active, not recruitingNCT06897358

Pharming Technologies B.V.Common Variable Immunodeficiency (CVID)

Start: 2025-02-12End: 2026-10-01Target: 20Updated: 2026-02-12

Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation

Active, not recruitingNCT06990529

Pharming Technologies B.V.PIDs Linked to PI3K

Start: 2025-04-29End: 2029-08-12Target: 12Updated: 2026-09-16

Phase 3

Pediatric Patients Aged 4 to 11 Years With APDS

Active, not recruitingNCT05438407

Pharming Technologies B.V.APDS

Start: 2023-02-01End: 2026-12-30Target: 15Updated: 2026-05-06

Pediatric Patients Aged 1 to 6 Years With APDS

Active, not recruitingNCT05693129

Pharming Technologies B.V.APDS

Start: 2023-08-30End: 2028-10-28Updated: 2026-06-15

An Open-Label Study to Assess the Safety & Efficacy of Leniolisib in Japanese Patients With APDS

RecruitingNCT06249997

Pharming Technologies B.V.APDS Gene Mutation

Start: 2023-08-03End: 2025-03-31Target: 3Updated: 2024-02-08

Related Papers

Leniolisib, a Selective Phosphoinositide 3-Kinase Delta (PI3Kδ) Inhibitor, in Japanese Patients Aged 12 and Over with Activated PI3Kδ Syndrome (APDS): Data from a 12-Week, Open-Label, Single-Arm Study

Journal of Human Immunity2026-06-04

Leniolisib reduced lymphoproliferative disease in murine autoimmune lymphoproliferative syndrome

Journal of Human Immunity2025-11-17

Primary and Safety Outcomes of a Phase 3 Open-Label, Single-Arm, 12-Week Study of Treatment with PI3Kδ Inhibitor Leniolisib in Pediatric Patients Aged 4–11 Years with Activated PI3Kδ Syndrome (APDS)

Journal of Human Immunity2025-04-25

Long-term treatment with selective PI3Kδ inhibitor leniolisib in adults with activated PI3Kδ syndrome

Blood Advances2024-04-0911 citations