Envarsus (LCP-Tacro) / Asahi Kasei Therapeutics - LARVOL DELTA

Tirzepatide-Associated Drug-Induced Liver Injury in a Liver Transplant Recipient: A Case Report (ACG 2026) - "She has been on 5 mg of extended-release tacrolimus (envarsus) daily with stable therapeutic trough levels. Review of other medications was notable for allopurinol, escitalopram, and glipizide, which were long-term with stable dose...Figure: Table 1. Liver Enzyme Trends During Tirzepatide Exposure and Following Discontinuation"

Case report • Clinical • Diabetes • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Transplantation • Type 2 Diabetes Mellitus

RENGEVITY-201: VEL-101 to Prevent Rejection After Kidney Transplantation (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Veloxis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Transplantation

Impact of Azole Antifungals on the Conversion Ratio of Immediate-release Tacrolimus to LCP-Tacrolimus Tablets in Non-kidney Solid Organ Transplant Recipients. (PubMed, Transplant Direct) - "There are limited data on the impact of azole antifungal use on the appropriate dose conversion strategy from immediate-release tacrolimus (IR-Tac) to once-daily extended-release tacrolimus (LCP-Tacro tablets [LCPT]). LCPT may be safely used in non-kidney transplant recipients regardless of azole antifungal use. Patients converting from IR-Tac to LCPT taking azole antifungals may warrant a higher dose conversion ratio, closer to 1, to achieve comparable tacrolimus trough concentrations."

Journal • Acute Kidney Injury • Nephrology • Solid Organ Transplantation • Transplantation

Extended-Release Tacrolimus Versus LifeCycle Pharma Tacrolimus in Kidney Transplant Recipients: A Switch Study. (PubMed, Ther Drug Monit) - "Conversion to LCP-tacrolimus with a 30% dose reduction achieved therapeutic C0 without differences in pill burden or overall exposure. In the CYP3A5 expressors, C0 was more strongly correlated with exposure to LCP-tacrolimus, suggesting more reliable trough monitoring. The small sample size, short follow-up period, and selection bias limit interpretation."

Journal • Transplantation • CYP3A5

PTAAK: Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants (clinicaltrials.gov) - P4 | N=60 | Active, not recruiting | Sponsor: Roy D. Bloom, MD | Trial completion date: May 2026 ➔ Dec 2026 | Trial primary completion date: May 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Transplantation

Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation (clinicaltrialsregister.eu) - P4 | N=28 | Recruiting | Sponsor: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Not yet recruiting ➔ Recruiting

Enrollment open • Pediatrics • Transplantation

Clinical Impact of MeltDose Technology Extended-Release Tacrolimus (LCPT) in Solid Organ Transplantation: A Systematic Review. (PubMed, Drug Des Devel Ther) - "Tacrolimus is a narrow-therapeutic-index immunosuppressant whose clinical performance is XR®Envarsus XR®), an extended-release tacrolimus formulation, was developed to enhance dissolution, improve bioavailability, and reduce pharmacokinetic variability...These findings support LCPT as a formulation-driven optimization of tacrolimus delivery. While pharmacokinetic advantages are evident, their translation into superior long-term clinical outcomes remains to be fully established."

Journal • Review • Solid Organ Transplantation • Transplant Rejection • Transplantation

Comparative bioequivalence of 1 mg and 4 mg tacrolimus extended-release tablets: randomized, open label, fully replicate, crossover trials in healthy adult subjects. (PubMed, Front Nephrol) - "These studies were planned to establish bioequivalence between two doses (1-mg and 4-mg) of test product (tacrolimus extended-release tablets manufactured by Intas Pharmaceuticals Ltd., India) with reference product (Envarsus XR® manufactured for Veloxis Pharmaceuticals, Inc., USA)...As per prevailing regulatory guidance, CTRI registration is not mandatory for such normal BA/BE studies. Additionally, the product under evaluation is already approved worldwide, and the studies do not constitute interventional clinical trials in patients."

Journal • Transplantation

Dose Adjustments of Tacrolimus Extended Release After Letermovir Initation in Kidney Transplant Recipients (ATC 2026) - "Data for IR TAC suggest 40-60% dose reductions, but the extent of this interaction is less characterized for TAC extended release (TacXR; Envarsus®). Although there was substantial inter-patient variability (SD ±30%), these findings suggest that an empiric 25-30% TacXR dose reduction at LTM initiation may provide a safe and standardized approach for management of this interaction. Unlike the 40% reduction suggested for TacIR, TacXR required a lower reduction of only ~25-30%, supporting formulation-specific dose adjustments to ensure adequate Tac exposure."

Clinical • Infectious Disease • Transplantation • CYP3A5

Concordance Between C/D Ratio and Cyp3A5 Genotype in African American Kidney Transplant Recipients Receiving Immediate-Release Tacrolimus (ATC 2026) - "The C/D ratio of IR-Tac correlates with CYP3A5 genotype in this cohort, supporting the C/D ratio as a prognostic tool in a broader population. Estimation of C/D ratios in the post-transplant setting may allow for identification of high-risk patients and implementation of mitigation strategies and/or more intensive monitoring for nephrotoxicity-related outcomes. Further clinical trials are needed in this regard.Table 1."

Clinical • Discordant • Transplantation • CYP3A5

Xanthogranulomatous Pyelonephritis Due to Mycobacterium Kansasii in an Allograft Kidney (ATC 2026) - "We herein describe a case of a patient with XGP due to Mycobacterium kansasii in an allograft kidney transplant.* A 54 year old male with a history of end stage renal disease due to hypertension status post deceased donor kidney transplant on envarsus, myfortic, and prednisone underwent renal biopsy for acute kidney injury 4 years after transplant...He underwent a nephrectomy of his allograft kidney and was initiated on rifabutin, azithromycin, and ethambutol.* XGP has previously been called the "great imitator" due to similar signs and symptoms of common ailments such as acute pyelonephritis... XGP is an uncommon and severe infection of the kidney. Diagnosis is challenging and if found late can lead to nephrectomy. Renal transplantation is a risk factor for XGP and in patients with early transformation to XGP with negative urine cultures, atypical infections such as mycobacterium should be considered."

Acute Kidney Injury • Cardiovascular • Fibrosis • Hypertension • Immunology • Infectious Disease • Inflammation • Nephrology • Renal Calculi

Envarsus vs Prograf - A Single-Center Retrospective Cohort Study on Pharmacokinetics and Clinical Outcomes (ATC 2026) - "In this single-center retrospective cohort of first kidney transplant recipients, Envarsus and Prograf demonstrated comparable patient and graft survival over a three-year follow-up period. Treatment with Envarsus was associated with significantly fewer biopsy-proven T-cell mediated rejections and lower hospitalization rates during the first year after transplantation. These findings support the clinical safety of Envarsus and suggest potential advantages regarding rejection-related outcomes."

Clinical data • Late-breaking abstract • PK/PD data • Retrospective data • Solid Organ Transplantation

Impact of Envarsus versus Immediate Release Tacrolimus Inpost-Bariatric Surgery After Kidney Transplant (ATC 2026) - "Although the numbers in the study are quite small, the data suggests that Envarsus may offer similar graft function and and maybe lower rejection rates compared to immediate-release Tacrolimus in post-bariatric surgery kidney transplant patients. From the limited numbers in this study - absorption and drug therapeutic levels don't seem to be impacted by extended release tacrolimus in patients with altered gut metabolism."

Bariatric surgery • Surgery • Antibody-mediated Rejection • Transplantation

Posttransplant Outcomes with Envarsus XR vs. Immediate-Release Tacrolimus in Adult Liver Transplant Recipients in the US (ATC 2026) - "In this large US cohort of adult liver transplant recipients, ENV was associated with improved unadjusted patient and graft survival at 1 and 2 years compared to IR-Tac. However, adjusted analyses showed no significant difference in composite outcomes, suggesting that overall effectiveness appears comparable between formulations."

Clinical • Post-transplantation • Transplant Rejection • Transplantation

Denovo Use of Immediate vs Extended-Release Tacrolimus Formulations in Deceased Donor Kidney Transplantation (ATC 2026) - "Exposure was defined as the tacrolimus formulation at discharge (Tac-IR-Brand [Prograf] N=21,261, Tac-IR-Gen N46,991, or LCP-Tac [Envarsus XR], N=11,581)... Denovo use of LCP-Tac was associated with a reduced risk of ACGF in DDKT."

Transplantation

Comparison of Female and Male Adult Liver Transplant Recipients Prescribed Envarsus XR and Immediate-Release Tacrolimus for Maintenance Immunosuppression in the US (ATC 2026) - "Among adult liver transplant recipients, ENV showed no significant sex-related differences in patient survival at 1 or 2 years posttransplant. Compared to female recipients on IR-Tac, female recipients on ENV demonstrated improved survival, and adjusted analyses found no evidence of increased hazard of death for those prescribed ENV."

Clinical • Transplantation

De Novo Use of Extended-Release vs Immediate-Release Tacrolimus and Risk of Graft Failure in Liver Transplant Recipients: (ATC 2026) - "*Purpose: The comparative effectiveness of de novo extended-release tacrolimus (Envarsus XR, LCP-Tac) versus immediate-release formulations brand (Prograf, Tac-IR-Brand) and generics (Tac-IR-Gen) in liver transplant recipients remains underexplored in large-scale studies. In this large national cohort, de novo use of the extended-release formulation LCP-Tac at discharge was associated with a significantly lower risk of ACGF compared to Tac-IR-Brand. This real-world evidence suggests a potential early protective benefit of LCP-Tac."

Clinical • Hepatology • Liver Failure • Transplant Rejection • Transplantation

Early Real-World Tacrolimus Trough-based Exposure after De Novo Initiation of Envarsus® in Primary Kidney Transplant Recipients (ERA 2026) - "Conclusion In primary kidney transplant recipients treated de novo with Envarsus®, tacrolimus trough levels during the early post-transplant period are highly variable. CYP3A5 genotype is associated with interindividual variability in dose-normalized, trough-based tacrolimus exposure, as reflected by the C 0 /D ratio."

Clinical • Real-world • Real-world evidence • Transplantation • CYP3A5

Envarsus vs Prograf - a single-center retrospective cohort study on pharmacokinetics and clinical outcomes (ERA 2026) - No abstract available

Clinical data • PK/PD data • Retrospective data • Transplantation

Integrating pharmacogenetic and clinical factors to predict the C0/D/W-based tacrolimus phenotype in kidney transplantation. (PubMed, Front Pharmacol) - "We conducted a single-centre retrospective study including 77 adult renal transplant recipients treated with prolonged-release tacrolimus formulations (Advagraf® or Envarsus®) and clinically stable...Additional pharmacogenetic markers showed limited incremental value. These findings support a combined genetic-clinical approach for tacrolimus dose individualization, although external validation in larger cohorts is warranted."

Biomarker • Journal • Nephrology • Transplantation • ABCB1 • CYP3A5

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Vanderbilt University Medical Center | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Transplantation

CMV Nephritis and Necrotizing Esophagoduodenitis in a D+/R– Kidney Transplant Recipient (NKF-SCM 2026) - "He completed 6 months of Valcyte prophylaxis and was maintained on Envarsus, azathioprine, and prednisone. High clinical suspicion, early tissue diagnosis, and prompt antiviral therapy are essential in managing severe CMV disease in high-risk kidney transplant recipients. Rapid initiation of ganciclovir in this case led to recovery and preserved allograft function."

Clinical • Cardiovascular • Chronic Kidney Disease • Cytomegalovirus Infection • Diabetes • Gastrointestinal Disorder • Gout • Heart Failure • Hematological Disorders • Infectious Disease • Inflammation • Inflammatory Arthritis • Metabolic Disorders • Nephrology • Renal Calculi • Transplantation

OPERATOR: Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™ (clinicaltrials.gov) - P4 | N=56 | Completed | Sponsor: Vanderbilt University Medical Center | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Oct 2025

HEOR • Trial completion • Trial completion date • Transplantation

DIFFERENTIAL IMPACT OF TACROLIMUS CONCENTRATION-TO-DOSE RATIO (C0/D RATIO) WITH DIFFERENT TACROLIMUS FORMULATIONS ON KIDNEY FUNCTION IN KIDNEY TRANSPLANT RECIPIENTS (KTRS) (ISN-WCN 2026) - "No significant differences were found between Envarsus and Advagraf after adjustment. Ongoing data collection aims to validate the C0/D ratio as a practical tool for individualized immunosuppression management."

Clinical • Infectious Disease • Solid Organ Transplantation • Transplantation

Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile (clinicaltrials.gov) - P2/3 | N=78 | Recruiting | Sponsor: Roberto Gedaly | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Mar 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease