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Drug

Everolimus

Approved · FDA / EMA
ClassFK506-binding protein 1A inhibitorEmerging researchLate-stage developmentCooling momentum
Also known as Afinitor, Torpenz, Zortress, 40-O-(2-hydroxyethyl)-rapamycin+2 more

Afinitor, Torpenz, Zortress, 40-O-(2-hydroxyethyl)-rapamycin, 42-O-(2-Hydroxyethyl)rapamycin, évérolimus.

18
Research papers
26
Active clinical trials
FKBP1A
Primary target
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: EVEROLIMUS (ANDA219464)

Regulatory2026-06-30FDA

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.

Research2019-09-28The New England journal of medicine

Approval: Votubia (EMA)

Regulatory2011-09-02EMA

Approval: Afinitor (EMA)

Regulatory2009-08-02EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Everolimus
Aliases & brands
AfinitorTorpenzZortress40-O-(2-hydroxyethyl)-rapamycin42-O-(2-Hydroxyethyl)rapamycinévérolimus
RxNorm CUI
141704
ChEMBL ID
CHEMBL1908360
ATC codes
L01EG02L04AH02
UNII
9HW64Q8G6G
Primary mechanism
FK506-binding protein 1A inhibitor
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORFK506-binding protein 1A inhibitor

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2009-08-02
Latest approval
2026-06-30
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 1 event
2026-06-30Approval
Approval: EVEROLIMUS (ANDA219464)
Evidence ↗
emaEuropean Medicines Agency· 2 events
2011-09-02Approval
Approval: Votubia (EMA)
Indication: Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberousShow full indication

Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. The evidence is based on analysis of change in sum of angiomyolipoma volume. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease?related symptoms, has not been demonstrated.

Evidence ↗
2009-08-02Approval
Approval: Afinitor (EMA)
Indication: Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combinationShow full indication

Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. Renal-cell carcinoma Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

199 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
199
registered trials across all phases
LATEST COMPLETION 2025
26
Active studies
14
Recruiting
64
Late-stage (III+)
117
Completed
56
Discontinued
PHASE DISTRIBUTIONn = 199
Early Phase 16Phase 134Phase 1 / 222Phase 273Phase 2 / 34Phase 329Phase 426Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

18 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092020
Most influential
Recent papers
Major research themes8
Calcineurin Inhibitors1Coronary Artery Bypass1Drug-Eluting Stents1Evolution, Molecular1Genetic Heterogeneity1Percutaneous Coronary Intervention1Phenotype1Quality of Life1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine4
  • Cancer3
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology2
  • American journal of hematology1
  • Annals of neurology1
  • Cancer chemotherapy and pharmacology1
Leading researchers
  • Witzig TE4
  • Ansell SM3
  • Choueiri TK3
  • Donskov F3
  • Escudier B3
  • Habermann TM3
  • Johnston PB3
  • Larkin J3
Leading institutions
free-text, unnormalised
  • The University of Texas MD Anderson Cancer Center3
  • Department of Pathology and Laboratory Medicine2
  • Mayo Clinic2
  • Mayo Clinic College of Medicine and Mayo Foundation2
  • Sidney Kimmel Comprehensive Cancer Center2
  • Aarhus University Hospital1

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications
Active research areas

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Everolimus, with 6 overlapping disease areas.

Shared target6 shared diseases4 shared papers

Studied across 2 of the same disease areas as Everolimus in the shared literature.

2 shared diseases1 shared paper

Studied across 2 of the same disease areas as Everolimus in the shared literature.

2 shared diseases1 shared paper

Studied across the same disease area as Everolimus in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Everolimus in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.