ZYDELIG
PeakNDAORALTABLETPriority Review
Approved
Jul 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
ZYDELIG by Gilead Sciences is 3-kinase, pi3kδ, which is expressed in normal and malignant b-cells. Approved for combination with rituximab. First approved in 2014.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYDELIG (idelalisib) is an oral small-molecule PI3K delta inhibitor approved by the FDA in July 2014 for treating hematologic malignancies. The drug mechanism selectively inhibits phosphatidylinositol 3-kinase delta, a pathway critical to B-cell proliferation and survival. It is indicated for relapsed chronic lymphocytic leukemia (CLL), follicular lymphoma, and small lymphocytic lymphoma (SLL) in combination with other agents.
$8MPart D
PeakThe product is in peak lifecycle stage with modest Medicare spending of $8M (2023), suggesting a mature, niche indication with stable to declining sales trajectory and smaller commercial teams.
Mechanism of Action
3-kinase, PI3Kδ, which is expressed in normal and malignant B-cells. Idelalisib induced apoptosis and inhibited proliferation in cell lines derived from malignant B-cells and in primary tumor cells. Idelalisib inhibits several cell signaling pathways, including B-cell receptor (BCR) signaling and…
Indications (1)
Clinical Trials (1)
1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation
Started Oct 2017
17 enrolled
Non Hodgkin LymphomaFollicular LymphomaIndolent Lymphoma+6 more
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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.