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Everolimus (Afinitor®)
Everolimus (Afinitor®) is a mTOR inhibitor Small molecule drug developed by Odense University Hospital. It is currently in Phase 3 development for Advanced renal cell carcinoma, Breast cancer (hormone receptor-positive, HER2-negative), Pancreatic neuroendocrine tumors. Also known as: Football fitness session.
Everolimus inhibits mTOR (mammalian target of rapamycin), a key protein kinase that controls cell growth and proliferation.
Everolimus (Afinitor) is a small molecule inhibitor of the FK506-binding protein 1A, which is involved in the mTOR pathway. It has been studied in various clinical trials for conditions such as postmenopausal bone loss, head and neck cancer, and breast cancer, among others.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Everolimus (Afinitor®) |
|---|---|
| Also known as | Football fitness session |
| Sponsor | Odense University Hospital |
| Drug class | mTOR inhibitor |
| Target | mTOR (mTORC1) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Everolimus is an mTOR inhibitor that suppresses the mTORC1 signaling pathway, which regulates protein synthesis, cell cycle progression, and angiogenesis. By blocking mTOR activity, it reduces tumor cell proliferation and can induce cell cycle arrest. This mechanism is particularly effective in cancers with dysregulated mTOR signaling and in preventing organ rejection.
Approved indications
- Advanced renal cell carcinoma
- Breast cancer (hormone receptor-positive, HER2-negative)
- Pancreatic neuroendocrine tumors
- Subependymal giant cell astrocytoma (SEGA)
- Organ transplant rejection prophylaxis
Common side effects
- Stomatitis/mouth ulcers
- Rash
- Diarrhea
- Fatigue
- Nausea
- Anemia
- Thrombocytopenia
- Hyperlipidemia
- Hyperglycemia
- Pneumonitis
Key clinical trials
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (PHASE1, PHASE2)
- Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer (PHASE2)
- Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer (PHASE4)
- A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE) (PHASE3)
- Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (PHASE3)
- Lenvatinib and Everolimus in Renal Cell Carcinoma (RCC) (PHASE1)
- Everolimus and/or Exercise to Prevent Bone Loss in Postmenopausal Women (PHASE2)
- Liver Transplantation With Tregs at MGH (PHASE1, PHASE2)
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:
- Everolimus (Afinitor®) CI brief — competitive landscape report
- Everolimus (Afinitor®) updates RSS · CI watch RSS
- Odense University Hospital portfolio CI
Frequently asked questions about Everolimus (Afinitor®)
What is Everolimus (Afinitor®)?
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Is Everolimus (Afinitor®) also known as anything else?
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Related
- Drug class: All mTOR inhibitor drugs
- Target: All drugs targeting mTOR (mTORC1)
- Manufacturer: Odense University Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced renal cell carcinoma
- Indication: Drugs for Breast cancer (hormone receptor-positive, HER2-negative)
- Indication: Drugs for Pancreatic neuroendocrine tumors
- Also known as: Football fitness session
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing