ENVARSUS XR

LOE Approaching

tacrolimus

NDAORALTABLET, EXTENDED RELEASE
Approved
Jul 2015
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20

Mechanism of Action

protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (an ubiquitous mammalian intracellular enzyme) is then formed and the phosphatase activity of calcineurin inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors such as…

Clinical Trials (5)

NCT07249346Phase 2Recruiting

Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation

Started Jun 2026
124 enrolled
LeukemiaMyelodysplasiaChronic Myelomonocytic Leukemia
NCT07412470Phase 2/3Not Yet Recruiting

A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation

Started Mar 2026
526 enrolled
Kidney Transplant Rejection
NCT06751992Phase 4Not Yet Recruiting

Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients

Started Dec 2025
NCT06615050Phase 3Recruiting

A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)

Started Apr 2025
572 enrolled
Graft-versus-host Disease (GVHD)
NCT04469842Phase 1Recruiting

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

Started Dec 2023

Loss of Exclusivity

LOE Date
Aug 30, 2028
30 months away
Patent Expiry
Aug 30, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
9549918
May 30, 2028
Product
10864199
May 30, 2028
U-2678
11110081
May 30, 2028
U-2678
11123331
May 30, 2028
U-2677
11419823
May 30, 2028
Product