Overview
Leniolisib is a potent and selective inhibitor of phosphoinositide 3-kinase δ (PI3Kδ). The FDA approved leniolisib on March 24, 2023, making it the first treatment for activated phosphoinositide 3-kinase delta syndrome (APDS). APDS is a primary immunodeficiency caused by mutations in genes encoding the PI3Kδ, thereby increasing the activity of PI3Kδ, causing immune dysfunction, and elevating susceptibility to infections. Leniolisib works to inhibit hyperactive PI3Kδ. Investigations for using leniolisib in primary Sjögren’s syndrome are ongoing.
Indication
Leniolisib is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
Associated Conditions
- Activated PI3 kinase delta syndrome
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/25 | Phase 2 | Recruiting | |||
2025/03/26 | Phase 2 | Recruiting | |||
2024/08/12 | Phase 2 | Recruiting | |||
2024/02/08 | Phase 3 | Recruiting | |||
2023/01/20 | Phase 3 | Active, not recruiting | |||
2024/10/01 | Phase 3 | Completed | |||
2016/08/09 | Phase 2 | Terminated | |||
2016/05/18 | Phase 2 | Completed | |||
2015/05/06 | Phase 2 | Completed |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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| No UK EMC drug information found for this drug. | |||||
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