NDAORALTABLETPriority Review
Approved
Mar 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
6/8 — Strong
Priority Review
JOENJA (leniolisib) by Pharming Group is pi3k-delta by blocking the active binding site of pi3k-delta. First approved in 2023.
Drug data last refreshed 14h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JOENJA (leniolisib) is an oral small-molecule PI3K-delta inhibitor approved in March 2023 for treating gain-of-function PI3K-delta-associated lymphoid hyperplasia. It works by selectively blocking PI3K-delta signaling, reducing B and T cell dysregulation and downstream mTOR/Akt pathway hyperactivity. The drug addresses a rare immunological disorder caused by genetic variants in PI3K-delta regulation.
$0.002BPart D
Peak5.3 years to LOEEarly-stage rare disease product with minimal current market penetration; small specialized commercial team likely focused on genetic testing partnerships and specialist outreach.
Mechanism of Action
PI3K-delta by blocking the active binding site of PI3K-delta. In cell-free isolated enzyme assays, leniolisib was selective for PI3K-delta over PI3K-alpha (28-fold), PI3K-beta (43-fold), and PI3K-gamma (257-fold), as well as the broader kinome. In cell-based assays, leniolisib reduced pAkt pathway…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation
Started Apr 2025
12 enrolled
PIDs Linked to PI3K
Career Relevance
JOENJA represents a rare disease commercialization opportunity with emphasis on diagnostic partnership, genetic counselor engagement, and specialist physician relationships rather than broad primary care promotion. Career growth depends on scaling the patient identification infrastructure and expanding into adjacent immunological disorders.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.