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 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYDELIG (idelalisib) is an oral small-molecule phosphoinositide 3-kinase (PI3K) inhibitor approved by the FDA in July 2014. It is indicated for use in hematologic malignancies, primarily chronic lymphocytic leukemia (CLL) and follicular lymphoma, where it inhibits PI3K signaling in B-cell tumors. The drug represents a targeted therapy approach for patients with specific B-cell malignancies.
$8MPart D
PeakProduct is at peak lifecycle stage with modest Medicare claims, indicating stable but not expanding market presence; commercial team size likely moderate.
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
Worked on ZYDELIG at Gilead Sciences? Share your interview experience or compensation data (+7 days Pro)
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.