NDAORALTABLET2 Generics Approved
Approved
Apr 2010
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
21
Data completeness
5/8 — Partial
ZORTRESS (everolimus) by Novartis is protein kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2010.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZORTRESS (everolimus) is an oral small-molecule mTOR kinase inhibitor approved in 2010 for a broad range of oncology indications and organ transplantation. It works by inhibiting mTOR signaling to reduce cell proliferation and angiogenesis across multiple cancer types and prevent rejection in transplant patients. The drug treats 26 approved and off-label indications spanning solid tumors, hematologic malignancies, and non-oncology organ preservation.
$2MPart D
LOE ApproachingDeclining
Product is in mature/declining phase with minimal Medicare spending, signaling reduced team size and commercial investment prioritization toward growth-stage assets.
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 (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.