biostudies-literatureUnknown24(1)Wohl DSChiesi FoundationUniversitätsklinikum Regensburg<h4>Background</h4>Graft rejection and chronic CNI toxicity remain obstacles to organ transplant success. Current formulations of tacrolimus, such as Prograf® and Advagraf™, exhibit limitations in terms of pharmacokinetics and tolerability, related in part to suboptimal bioavailability. As dosing non-compliance can result in graft rejection, the once daily formulation of tacrolimus, Advagraf™, was developed (vs 2x/day Prograf®). Benefits of Advagraf™ are counterbalanced by delayed achievement of therapeutic trough levels and need for up to 50% higher doses to maintain Prograf®-equivalent troughs. Envarsus® is also a prolonged-release once-daily tacrolimus formulation, developed using MeltDose™ drug-delivery technology to increase drug bioavailability; improved bioavailability results in loTrials325https://www.ebi.ac.uk/biostudies/studies/S-EPMC10176804biostudies-literatureEnGraft: a multicentre, open-label, randomised, two-arm, superiority study protocol to assess bioavailability and practicability of Envarsus® versus Advagraf™ in liver transplant recipients.PMC10176804Gotz MBraun FVondran FWRGeissler EKJames BHolub-Hayles IPratschke JEnGraft Trial GroupHerden UMittler JCroner RBrennfleck FSchnitzbauer AAVogel TWohl DSWilluweit KBerg TMutzbauer ISchlitt HJBrunner SMNadalin SBaccar SMerle UNeumann UPRauchfuß FfalseEnGraft: a multicentre, open-label, randomised, two-arm, superiority study protocol to assess bioavailability and practicability of Envarsus® versus Advagraf™ in liver transplant recipients.<h4>Background</h4>Graft rejection and chronic CNI toxicity remain obstacles to organ transplant success. Current formulations of tacrolimus, such as Prograf® and Advagraf™, exhibit limitations in terms of pharmacokinetics and tolerability, related in part to suboptimal bioavailability. As dosing non-compliance can result in graft rejection, the once daily formulation of tacrolimus, Advagraf™, was developed (vs 2x/day Prograf®). Benefits of Advagraf™ are counterbalanced by delayed achievement of therapeutic trough levels and need for up to 50% higher doses to maintain Prograf®-equivalent troughs. Envarsus® is also a prolonged-release once-daily tacrolimus formulation, developed using MeltDose™ drug-delivery technology to increase drug bioavailability; improved bioavailability results in lo2023-01-01T00:00:00Z2023 May2025-04-04T20:00:15.935Z2024-11-13T02:32:11.401ZS-EPMC101768043717028410.1186/s13063-023-07344-7