ASTAGRAF XL

Peak

tacrolimus extended-release capsules

NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jul 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3

Mechanism of Action

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

Clinical Trials (3)

NCT03194321Phase 4Completed

Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients

Started Sep 2017
20 enrolled
End Stage Renal Disease
NCT02953873Phase 4Completed

Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients

Started May 2017
25 enrolled
Immunosuppression
NCT02723591Phase 4Completed

To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients

Started Sep 2016
599 enrolled
Kidney Transplantation