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everolimus

Generic: EVEROLIMUS·Brand: AFINITOR, AFINITOR DISPERZ, Afinitor, EVEROLIMUS, ZORTRESS

everolimus: developed by 1 company · 49 clinical trials tracked · 2 FDA decisions.

everolimus evidence translation

What we can confirm

2 FDA records · 49 tracked trials

What it means

Source-backed records connect everolimus to NVS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could everolimus → NVS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 12 study sponsors
Development Pipeline (1)
CompanyPhase
Novartis AG (NVS)Approved
Clinical Trials (49)showing 10 most recent

A Phase II Study of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD) Combined With Everolimus in Patients With Recurrent or Metastatic ER-Positive (ER+) Endometrial Cancer (ELAVERA)

NCT07634601·Phase 2
Not yet recruiting

Primary endpoint: Proportion of patients progression-free

Interventionalopen50 targetStarted 2026-12Completion 2029-121 site · United StatesJonsson Comprehensive Cancer Center

A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)

NCT07426484·Phase 4
Not yet recruiting

Primary endpoint: Best Overall Response Rate (BORR)

Interventionalopen80 targetStarted 2026-07Completion 2032-122 sites · United StatesDana-Farber Cancer Institute

Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer

NCT07318324·Phase 1
Recruiting

Primary endpoint: Safety and adverse events (AEs).

Interventionalopen31 targetStarted 2026-05Completion 2030-081 site · United StatesM.D. Anderson Cancer Center

Characterization of mTOR Inhibitor Pharmacokinetics and Pharmacodynamics in Older Adults .

NCT06727305·Phase 1/Phase 2
Recruiting

Primary endpoint: Cmax for Sirolimus

InterventionalRandomizedopen60 targetStarted 2026-05Completion 2027-111 site · United StatesUniversity of Texas Southwestern Medical Center

RESTOR [Rapamycin and Everolimus Study Towards Older Rejuvenation]: An Exploratory PK/PD Study of mTOR Inhibition in Older Human Subjects

NCT06658093·Early Phase 1
Recruiting

Primary endpoint: Pharmacokinetics (PK) of mTOR inhibitor in blood

InterventionalRandomizeddouble194 targetStarted 2026-03Completion 2028-071 site · United StatesThe University of Texas Health Science Center at San Antonio

A Phase 2/3, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors

NCT06943755·Phase 2/Phase 3·EXEL
Recruiting

Primary endpoint: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

InterventionalRandomizedopen440 targetStarted 2025-07Completion 2029-0650 sites · Australia, Austria, Belgium, United StatesExelixis

Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas

Recruiting

Primary endpoint: Determination of the safety and technical feasibility of microdevice insertion/removal, as assessed by adverse events by CTCAE 5.0.

Interventionalopen20 targetStarted 2025-02Completion 2028-121 site · United StatesM.D. Anderson Cancer Center

A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+/HER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4/6 Inhibitors

NCT06382948·Phase 3
Recruiting

Primary endpoint: To demonstrate superiority of elacestrant+everolimus vs. elacestrant+placebo in prolonging PFS based on a BIRC in patients with ER[+]/HER2[-], ESR1-mutated, ABC that have previously received ET+CDK4/6i (all patients).

InterventionalRandomizeddouble240 targetStarted 2024-12Completion 2028-0450 sites · Austria, Brazil, Czechia, France…MedSIR

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)

NCT06428396·Phase 2
Active, not recruiting

Primary endpoint: Progression-free Survival (PFS)

InterventionalRandomizedopen120 targetStarted 2024-11Completion 2028-1241 sites · Argentina, Canada, Chile, Colombia…Merck Sharp & Dohme LLC

Targeting mTOR With Everolimus and/or Physical Training for Preventing Postmenopausal Bone Loss and Accelerated Skeletal Aging: The RapaLoad Study

NCT06789900·Phase 2
Active, not recruiting

Primary endpoint: Procollagen type 1 N-terminal propeptide (P1NP)

InterventionalRandomizedopen136 targetStarted 2024-10Completion 2026-101 site · DenmarkOdense University Hospital
FDA Decisions2 records
Approval(NVS)FDA ↗
NDA021560Type 5 - New Formulation or New ManufacturerStandardOralTablet
Approval(NVS)FDA ↗
NDA022334Type 1 - New Molecular EntityPriorityOralTablet

Frequently asked questions

Who is developing everolimus?

everolimus is being developed by Novartis AG.

How many clinical trials involve everolimus?

BioSniper tracks 49 clinical trials involving everolimus.

What is everolimus's latest FDA decision?

The most recent tracked FDA decision for everolimus is Approval, dated April 20, 2010.