Last reviewed · How we verify
Drug: Everolimus
Everolimus inhibits mTOR (mammalian target of rapamycin), a key protein kinase that regulates cell growth and proliferation.
Everolimus inhibits mTOR (mammalian target of rapamycin), a key protein kinase that regulates cell growth and proliferation. Used for Neuroendocrine tumors (pancreatic and non-pancreatic), Advanced renal cell carcinoma, Breast cancer (hormone receptor positive).
At a glance
| Generic name | Drug: Everolimus |
|---|---|
| Also known as | Afinitor |
| Sponsor | Grupo Espanol de Tumores Neuroendocrinos |
| Drug class | mTOR inhibitor |
| Target | mTORC1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Everolimus is an mTOR inhibitor that suppresses cell cycle progression and angiogenesis by blocking the mTORC1 signaling pathway. This leads to reduced tumor cell proliferation and is particularly effective in neuroendocrine tumors where mTOR signaling is often dysregulated. The drug also has immunomodulatory effects that enhance anti-tumor immunity.
Approved indications
- Neuroendocrine tumors (pancreatic and non-pancreatic)
- Advanced renal cell carcinoma
- Breast cancer (hormone receptor positive)
Common side effects
- Stomatitis
- Infections
- Rash
- Diarrhea
- Fatigue
- Hyperglycemia
- Hyperlipidemia
- Pneumonitis
Key clinical trials
- Esprit BTK Post-Approval Study (NA)
- Comparison of a Contemporary Sirolimus-eluting Stent (ihtDEStiny®) With Another Everolimus-eluting Stent (Xience™), Both With Permanent Polymers, in Patients With Acute Coronary Syndrome and de Novo Coronary Artery Lesions (NA)
- Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
- Drug Screening Using Novel IMD in Renal Cell Carcinoma (PHASE1)
- Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) (PHASE2)
- Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Drug: Everolimus CI brief — competitive landscape report
- Drug: Everolimus updates RSS · CI watch RSS
- Grupo Espanol de Tumores Neuroendocrinos portfolio CI