NDAORALTABLETPriority Review
Approved
Mar 2009
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
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 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AFINITOR (everolimus) is an oral mTOR kinase inhibitor approved in 2009 for multiple oncology indications including renal cell carcinoma, pancreatic neuroendocrine tumors, and breast cancer. It works by inhibiting the mammalian target of rapamycin (mTOR) protein kinase, which suppresses tumor cell proliferation and angiogenesis. The drug is administered as an oral tablet and represents a foundational small-molecule targeted therapy in the kinase inhibitor class.
$30MPart D
LOE ApproachingDeclining
2.0 years to LOEProduct is in decline phase with 2 years remaining exclusivity; commercial teams are likely focused on LOE mitigation and portfolio transition rather than growth investments.
Mechanism 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 (20)
Elacestrant With Everolimus for the Treatment of Recurrent Advanced or Metastatic ER-Positive Endometrial Cancer
Started Dec 2026
50 enrolled
Advanced Endometrial CarcinomaMetastatic Endometrial CarcinomaRecurrent Endometrial Carcinoma+2 more
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)
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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.