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 8h ago · AI intelligence enriched 1w 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 activating PI3K-delta syndrome (APDS), a rare genetic immunodeficiency disorder. It works by selectively blocking PI3K-delta activity with 28–257-fold selectivity over other PI3K isoforms, thereby normalizing dysregulated B and T cell function.
$0.002BPart D
Peak5.7 years to LOEEarly-stage peak commercial phase with minimal Part D penetration (50 claims, $2M spend in 2023) indicates small, specialized patient population and focused field team.
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
Working on JOENJA offers exposure to orphan drug commercialization and rare disease expertise in an emerging, high-growth space with limited competition. The role is ideal for professionals seeking specialization in precision/genetic medicine but requires patience with ultra-small patient populations and limited team expansion.
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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.