NDAORALTABLETPriority Review
Approved
Mar 2009
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
21
Data completeness
7/8 — Comprehensive
Priority Review
AFINITOR (everolimus) by Novartis is protein kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2009.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AFINITOR (everolimus) is an oral small-molecule protein kinase inhibitor approved by the FDA in March 2009 under Novartis sponsorship. It operates as an mTOR pathway inhibitor used primarily in oncology to treat various cancers where kinase signaling drives malignant cell growth and proliferation. The drug represents a foundational kinase inhibitor in the oncology armamentarium, competing in a crowded landscape of targeted cancer therapies with varying mechanisms and indications.
$0.0BPart D
2.2 years to LOEMechanism of Action
Protein Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
Started Apr 2026
400 enrolled
Chronic Limb Threatening IschemiaChronic Limb-Threatening Ischemia
To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System
Started Aug 2025
2,000 enrolled
Coronary Artery DiseaseCoronary Artery StenosisPercutaneous Coronary Intervention+1 more
Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea
Started Aug 2025
140 enrolled
Heart Transplant
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Started Jul 2025
440 enrolled
Pancreatic Neuroendocrine Tumor (pNET)Extra-Pancreatic Neuroendocrine Tumor (epNET)
An Open-Label, Single-Arm Exploratory Clinical Study of Everolimus for the Treatment of Vascular Malformations
Started Jul 2025
10 enrolled
Vascular Malformations
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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.