Everolimus: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Everolimus appears in the FDA drug-label database. Marketed as Everolimus.
- Drug class
- Kinase Inhibitor; mTOR Inhibitor Immunosuppressant (FDA established pharmacologic class)
- Mechanism of action
- Protein Kinase Inhibitors; Cytochrome P450 3A4 Inhibitors; Cytochrome P450 2D6 Inhibitors; mTOR Inhibitors (as stated on the FDA label)
- Boxed warning
- The FDA label for Everolimus carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
& USAGE Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: • Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1 ) • Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2 , 5.5 ) Limitations of Use: Safety and efficacy have not been established in the following: • Kidney transplant patients at high immunologic risk ( 1.3 ) • Recipients of transplanted organs other than kidney or liver ( 1.3 , 5.7 ) • Pediatric patients (less than 18 years) ( 1.3 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplantation Everolimus tablets are indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunologic risk receiving a kidney transplant [see Clinical Studies ( 14.1 )]. Everolimus tablets are to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. Therapeutic drug monitoring (TDM) of everolimus tablets and cyclosporine is…
Phase breakdown
Conditions being studied
Recruiting trials involving Everolimus
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
- A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
- Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer
- Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy
- Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.
- Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
- Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype
- Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
- Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
- Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
- Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women
- SNF Platform Study of HR+/ HER2-advanced Breast Cancer
- Safety and Durability of Sirolimus for Treatment of LAM
- Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
- Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
- Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
- The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy
- Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Common questions
Is Everolimus FDA-approved?
Yes, marketed as Everolimus. Its FDA label carries a boxed warning.
How many recruiting trials involve Everolimus?
18 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.