Drugs / Everolimus
Everolimus
DrugMarketed as Afinitor
Everolimus is an mTOR-targeted medicine marketed as Afinitor and used in oncology and other indications. It is used as targeted therapy in renal cell cancer and other tumors, and it is also used as an immunosuppressant in transplant settings. The drug has multiple U.S. FDA approvals across indications.
- Trials
- 795
- Recruiting
- 49
- Completed
- 465
- With results
- 305
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 3 | — | — | — | 4 | 2 | — | — | — | — | 9 |
| Phase 1 | 5 | 1 | — | 10 | 101 | 22 | 3 | — | 7 | — | 149 |
| Phase 1/2 | 5 | 2 | 1 | 2 | 65 | 14 | 1 | 1 | 8 | — | 99 |
| Phase 2 | 23 | 4 | — | 16 | 156 | 54 | 9 | 2 | 35 | — | 299 |
| Phase 2/3 | 2 | 1 | — | 1 | 1 | 3 | 1 | — | 2 | — | 11 |
| Phase 3 | 6 | 2 | — | 10 | 63 | 8 | 2 | — | 8 | — | 99 |
| Phase 4 | 1 | 2 | 1 | 2 | 58 | 8 | 2 | — | 15 | — | 89 |
| Not applicable | 2 | — | — | 1 | 10 | 3 | 2 | — | 7 | — | 25 |
| Unknown | 2 | — | — | — | 7 | — | — | — | 1 | 5 | 15 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Breast Neoplasms | — | 20 | 13 | 49 | — | 18 | 2 | 1 | 4 | 107 |
| Carcinoma, Renal Cell | 1 | 17 | 6 | 30 | — | 7 | 5 | 3 | 2 | 71 |
| Neoplasm Metastasis | 1 | 15 | 5 | 18 | 1 | 3 | 1 | 4 | — | 48 |
| Neoplasms | — | 10 | 3 | 15 | — | 2 | 3 | 3 | — | 36 |
| Neuroendocrine Tumors | — | 10 | 2 | 11 | 1 | 6 | 3 | — | 2 | 35 |
| Kidney Neoplasms | — | 5 | 3 | 14 | — | 3 | 2 | — | — | 27 |
| Recurrence | 1 | 8 | 3 | 5 | — | 1 | — | 1 | — | 19 |
| Tuberous Sclerosis | — | 1 | 5 | 5 | 2 | 3 | 2 | — | — | 18 |
| Carcinoma, Non-Small-Cell Lung | — | 13 | 2 | 2 | — | — | — | — | — | 17 |
| Lymphoma | — | 5 | 2 | 6 | — | 1 | 1 | — | — | 15 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Novartis Pharmaceuticals | 134 | 43 |
| 2 | M.D. Anderson Cancer Center | 35 | 0 |
| 3 | Dana-Farber Cancer Institute | 19 | 0 |
| 4 | Memorial Sloan Kettering Cancer Center | 16 | 0 |
| 5 | Emory University | 13 | 0 |
| 6 | Fudan University | 11 | 2 |
| 7 | National Cancer Institute (NCI) | 11 | 1 |
| 8 | Mayo Clinic | 10 | 0 |
| 9 | SCRI Development Innovations, LLC | 10 | 0 |
| 10 | Alliance for Clinical Trials in Oncology | 8 | 1 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Everolimus | 795 |
| 2 | Mycophenolic Acid | 74 |
| 3 | Tacrolimus | 61 |
| 4 | Cyclosporine | 41 |
| 5 | Bevacizumab | 37 |
| 6 | exemestane | 37 |
| 7 | Sorafenib | 32 |
| 8 | Sirolimus | 31 |
| 9 | Letrozole | 26 |
| 10 | Paclitaxel | 25 |
Evidence
- Results reported
- 65.6%305 of 465 completed
- Published
- 15.3%71 of 465 completed
- Primary endpoint met
- 40.9%36 of 88 analyses
- Median months to report
- 12
Documents disclosed
Trial profile
- Median enrollment
- 44
- Median duration
- 52.9months
- Countries
- 68
- Study sites
- 7852
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 8
- Phase 1
- 27
- Phase 1/2
- 40
- Phase 2
- 43
- Phase 2/3
- 60
- Phase 3
- 256
- Phase 4
- 71
- Not applicable
- 36
- Unknown
- 99
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Houston | United States | 116 |
| 2 | Boston | United States | 105 |
| 3 | New York | United States | 104 |
| 4 | Los Angeles | United States | 77 |
| 5 | Barcelona | Spain | 75 |
| 6 | Berlin | Germany | 69 |
| 7 | Nashville | United States | 67 |
| 8 | Milan | Italy | 65 |
| 9 | Madrid | Spain | 64 |
| 10 | Philadelphia | United States | 62 |
Terminations
- Terminated
- 114
- Withdrawn
- 20
- Suspended
- 3
- Stopped for recruitment
- 6.3%50 of 795 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT04118556 Terminated | Terminated | Too slow recruitment | 2026-04-29 |
| NCT03065387 Terminated | Terminated | \<75% participation | 2026-04-23 |
| NCT04895748 Terminated | Terminated | Business decision and not related to safety concerns | 2026-02-13 |
| NCT03632317 Withdrawn | Withdrawn | low accrual | 2025-10-31 |
| NCT02860494 Withdrawn | Withdrawn | Pharmaceutical and financial difficulties | 2024-12-31 |
| NCT04305444 Terminated | Terminated | Despite the efforts of our dedicated team and initial progress, we were unable to secure the necessary financial resources to continue the study. We appreciate the support and participation of all involved. | 2024-12-31 |
| NCT03284957 Terminated | Terminated | Sponsor decision to prematurely stop the study, not linked to any safety concern. | 2024-11-08 |
| NCT05079360 Withdrawn | Withdrawn | Decided to halt and will potentially reopen in the future. | 2024-05-26 |
| NCT01345136 Terminated | Terminated | slow accrual | 2024-02-06 |
| NCT05065411 Terminated | Terminated | Business decision | 2024-01-09 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: