Drugs / Tacrolimus
Tacrolimus
DrugTacrolimus is marketed as Prograf and is a calcineurin-inhibitor immunosuppressant used in combination regimens to prevent allogeneic organ transplant rejection in liver, kidney, heart, and lung recipients. It remains a core transplant immunosuppressive therapy. U.S. initial approval was in 1994.
- Trials
- 1008
- Recruiting
- 69
- Completed
- 595
- With results
- 343
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Approved for marketing | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 1 | 1 | 1 | — | 4 | 4 | 2 | — | — | — | — | 13 |
| Phase 1 | 7 | — | — | 5 | 53 | 5 | 8 | 2 | 5 | — | — | 85 |
| Phase 1/2 | 4 | — | — | 2 | 34 | 10 | 4 | — | 8 | — | — | 62 |
| Phase 2 | 34 | 6 | 2 | 25 | 178 | 47 | 19 | 1 | 10 | — | — | 322 |
| Phase 2/3 | 7 | — | 1 | 2 | 8 | 7 | 2 | — | 7 | — | — | 34 |
| Phase 3 | 5 | 2 | — | 5 | 97 | 12 | 4 | — | 6 | — | — | 131 |
| Phase 4 | 6 | 4 | 3 | 5 | 159 | 19 | 5 | — | 42 | — | — | 243 |
| Not applicable | 2 | 2 | — | 2 | 38 | 6 | 3 | — | 14 | — | — | 67 |
| Unknown | 3 | — | — | — | 24 | 2 | 1 | 1 | 16 | 1 | 3 | 51 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Leukemia, Myeloid, Acute | — | 21 | 13 | 79 | 1 | 8 | — | 3 | 1 | 126 |
| Myelodysplastic Syndromes | — | 20 | 14 | 78 | 1 | 6 | — | 3 | 1 | 123 |
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | — | 17 | 9 | 70 | 1 | 6 | — | 3 | 1 | 107 |
| Graft vs Host Disease | — | 7 | 12 | 51 | 3 | 9 | 4 | 2 | 1 | 89 |
| Leukemia | — | 14 | 12 | 55 | 1 | 1 | — | 2 | 1 | 86 |
| Hodgkin Disease | — | 11 | 10 | 55 | — | 2 | — | 2 | 1 | 81 |
| Leukemia, Lymphocytic, Chronic, B-Cell | — | 11 | 4 | 58 | — | 2 | — | 2 | 1 | 78 |
| Lymphoma | — | 11 | 11 | 48 | — | 2 | — | 3 | 1 | 76 |
| Lymphoma, Non-Hodgkin | — | 10 | 6 | 54 | — | 3 | — | 1 | 1 | 75 |
| Multiple Myeloma | 1 | 12 | 12 | 45 | — | 1 | — | 3 | 1 | 75 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Astellas Pharma Inc | 83 | 40 |
| 2 | M.D. Anderson Cancer Center | 42 | 1 |
| 3 | Fred Hutchinson Cancer Center | 35 | 1 |
| 4 | National Institute of Allergy and Infectious Diseases (NIAID) | 34 | 1 |
| 5 | Novartis Pharmaceuticals | 24 | 8 |
| 6 | City of Hope Medical Center | 23 | 0 |
| 7 | National Cancer Institute (NCI) | 17 | 0 |
| 8 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 16 | 0 |
| 9 | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | 14 | 0 |
| 10 | Veloxis Pharmaceuticals | 13 | 5 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Tacrolimus | 1008 |
| 2 | Mycophenolic Acid | 360 |
| 3 | Cyclophosphamide | 194 |
| 4 | fludarabine phosphate | 150 |
| 5 | Cyclosporine | 132 |
| 6 | Sirolimus | 130 |
| 7 | Methotrexate | 127 |
| 8 | fludarabine | 119 |
| 9 | Whole-Body Irradiation | 106 |
| 10 | Busulfan | 104 |
Evidence
- Results reported
- 57.6%343 of 595 completed
- Published
- 14.6%87 of 595 completed
- Primary endpoint met
- 32.5%37 of 114 analyses
- Median months to report
- 16
Documents disclosed
Trial profile
- Median enrollment
- 49
- Median duration
- 44.2months
- Countries
- 64
- Study sites
- 4592
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 10
- Phase 1
- 24
- Phase 1/2
- 29
- Phase 2
- 40
- Phase 2/3
- 40
- Phase 3
- 102
- Phase 4
- 75
- Not applicable
- 40
- Unknown
- 126
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 103 |
| 2 | Houston | United States | 93 |
| 3 | Chicago | United States | 87 |
| 4 | Philadelphia | United States | 86 |
| 5 | Boston | United States | 84 |
| 6 | San Francisco | United States | 76 |
| 7 | Baltimore | United States | 67 |
| 8 | Atlanta | United States | 66 |
| 9 | St Louis | United States | 66 |
| 10 | Seattle | United States | 65 |
Terminations
- Terminated
- 112
- Withdrawn
- 48
- Suspended
- 4
- Stopped for recruitment
- 5.3%53 of 1008 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 |
|---|---|---|---|
| NCT07349771 Withdrawn | Withdrawn | Sponsor declined to fund study due to inability to agree on IP. | 2033-06-01 |
| NCT04961801 Withdrawn | Withdrawn | Manufacturer AstraZeneca withdrew the study due to lack of funding | 2030-01-31 |
| NCT02333162 Suspended | Suspended | Enrollment on hold pending amendment | 2028-12-01 |
| NCT06680661 Suspended | Suspended | insufficient funding | 2028-10-31 |
| NCT04415476 Withdrawn | Withdrawn | Study did not proceed to IRB approval. | 2028-06-30 |
| NCT05073822 Withdrawn | Withdrawn | Funding not secured | 2027-02-20 |
| NCT03605654 Withdrawn | Withdrawn | Lack of funding | 2026-10-31 |
| NCT03467386 Suspended | Suspended | accrual goal | 2026-09-06 |
| NCT03240822 Withdrawn | Withdrawn | Lack of Funding | 2025-12-31 |
| NCT03640026 Terminated | Terminated | Recruitment difficulties | 2025-11-10 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: