Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Sold as Joenja. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Leniolisib Phosphate (sold as Joenja), first approved Mar 24, 2023, with 1 new use approved and 0 published complete response letters.
First approved: Mar 24, 2023
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $5.1M
Orphan exclusivity until: Mar 24, 2030
First approved in the EU: May 21, 2026
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
