tacrolimus XR / Generic mfg. - LARVOL DELTA

Concentration-to-Dose Ratio Differences Between Once-Daily Tacrolimus Formulations: A Five-Year Real-World Pharmacokinetic Study in Kidney Transplantation. (PubMed, Eur J Drug Metab Pharmacokinet) - "LCP-Tac was associated with lower dose requirements and higher, more stable C/D ratios compared with ER-Tac, suggesting formulation-dependent differences in tacrolimus pharmacokinetics. The C/D ratio may serve as a simple, clinically applicable surrogate marker for long-term pharmacokinetic monitoring in kidney transplant recipients."

Journal • PK/PD data • Real-world evidence • Diabetes • Metabolic Disorders • Transplant Rejection • Transplantation

Early twice-daily dosing of extended-release tacrolimus improves target trough attainment after kidney transplantation: A prospective randomized controlled study (TTS 2026) - "Early twice-daily dosing of extended-release tacrolimus improved postoperative day 4 target trough concentration attainment after kidney transplantation without an apparent increase in short-term safety concerns. This strategy appears feasible for early tacrolimus initiation, but larger studies with longer follow-up and pharmacokinetic assessment are warranted. Figure 1."

Clinical • Diabetes • Infectious Disease • Respiratory Diseases • Transplant Rejection • Transplantation • CYP3A5

Porto-Sinusoidal Vascular Disorder (PSVD) Associated with Tacrolimus in a Kidney Transplant Recipient (TTS 2026) - "Two years post-transplant, patient was diagnosed with chronic antibody-mediated rejection (cAMR) and treated with plasmapheresis, IVIg, and rituximab; during this period, tacrolimus levels were maintained between 7–10 ng/mL...Given the absence of other known triggers, extended-release tacrolimus was identified as the potential offending agent and was switched to cyclosporin...Clinicians should consider PSVD as a differential diagnosis for unexplained portal hypertension in transplant recipients, even when traditional triggers like azathioprine are absent. The rapid clinical recovery following the cessation of tacrolimus strongly supports a causal link."

Clinical • Antibody-mediated Rejection • Cardiovascular • Fibrosis • Hepatology • Immunology • Portal Hypertension • Transplantation

Development of a sampling-time error correction model for trough concentrations of extended-release tacrolimus in kidney transplant recipients (TTS 2026) - "This correction model based on measured concentration, CYP3A5 metabolic phenotype, hematocrit, and albumin reduced sampling-time-related errors in extended-release tacrolimus trough assessment and may improve the accuracy of outpatient therapeutic drug monitoring in kidney transplant recipients. Figure 1. Distribution of actual outpatient sampling times for tacrolimus monitoring Figure 2."

Clinical • Transplantation • CYP3A5

Once-monthly long-acting injectable tacrolimus with high bioavailability and low fluctuation: A potential strategy to imporve transplant outcomes (TTS 2026) - "However, currently available oral formulations, including Prograf® and Advagraf®, are associated with limited oral bioavailability, food-dependent absorption, and substantial inter- and intra-individual pharmacokinetic variability, resulting in unpredictable systemic exposure. This Once-Monthly Long-acting injectable Tacrolimus provides sustained systemic exposure with enhanced bioavailability and reduced fluctuation in preclinical models. By mitigating peak-related toxicity and minimizing variability in drug exposure, this approach has the potential to improve exposure consistency and medication adherence, thereby addressing key limitations of oral tacrolimus therapy. These findings support further clinical development to evaluate its potential to improve transplant outcomes and reduce rejection risk."

Solid Organ Transplantation • Transplant Rejection • Transplantation

Bioequivalence of generic immunosuppressants in kidney transplants (TTS 2026) - "This has been the case for Tacrolimus Accord (FDA) and Tacni® by Teva (EMA). We aimed to simultaneously assess the bioequivalence of generic formulations of tacrolimus (Ascend) and mycophenolate mofetil (Accord) in stable kidney transplant recipients (KTR), using Prograf (Astellas) and CellCept (Roche) as reference products... To our knowledge, this is the first simultaneous assessment of generic Tac and MMF in KTR. We were unable to demonstrate bioequivalence for the tested generic Tac, despite its EMA approval. Importantly, the discrepancy in Tac AUC0-12 and Cmax was not detected by traditional pre-dose (C0) concentration monitoring."

Solid Organ Transplantation • Transplantation

Successful living-donor kidney transplantation in a homozygous hemoglobin C recipient from a heterozygous donor (TTS 2026) - "Induction immunosuppression with thymoglobulin was administered, followed by maintenance therapy with extended-release tacrolimus, mycophenolate mofetil, and corticosteroids... Kidney transplantation from a heterozygous Hb C donor to a homozygous Hb C recipient is feasible and safe when supported by rigorous multidisciplinary evaluation, appropriate infectious disease management, and individualized vascular reconstruction. Homozygous Hb C disease, even in the context of treated latent tuberculosis, should not be considered an absolute contraindication to kidney transplantation. This case broadens the evidence base and supports reconsideration of transplant eligibility in rare and medically complex populations."

Chronic Kidney Disease • Hematological Disorders • Infectious Disease • Nephrology • Respiratory Diseases • Transplantation • Tuberculosis

Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Mayo Clinic | N=72 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Oncology • Transplantation

Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • HLA-DRB1

Comparison in Patients' Adherence, Adverse Effects, and Clinical Outcomes Among Liver Transplant Recipients Using Immediate-Release Tacrolimus (Prograf®) Versus Extended-Release Tacrolimus (Advagraf®): First Report from Iran. (PubMed, Arch Iran Med) - "In this observational study, the once-daily Advagraf® formulation was associated with significantly better medication adherence and a lower reported incidence of tremors compared to twice-daily Prograf®. These findings should be interpreted in the context of the study's non-randomized design and potential confounding."

Adverse events • Clinical • Clinical data • Journal • Observational data • Movement Disorders • Transplant Rejection • Transplantation

A Comparative Study of Once-Daily versus Twice-Daily Tacrolimus in Deceased Donor Kidney Transplant Recipients: A National Cohort Analysis. (PubMed, Am J Transplant) - "The association was consistent in a sensitivity analysis restricted to centers prescribing all three formulations (HR 0.872; 95% CI 0.789-0.963) and in a propensity-score-matched analysis comparing LCPT with combined IR tacrolimus (HR 0.913; 95% CI 0.836-0.998). In this national DDKT cohort, LCPT was associated with a modestly lower adjusted risk of ACGF relative to IR tacrolimus."

Journal • Transplantation

Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov) - P3 | N=66 | Active, not recruiting | Sponsor: Children's Oncology Group | N=435 ➔ 66 | Trial completion date: Jun 2026 ➔ Jul 2027

Enrollment change • Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • ABL1 • BCR • CEBPA • FLT3 • HLA-B • HLA-C • HLA-DQB1 • HLA-DRB1 • KMT2A • NPM1

Low Tacrolimus C0/Dose Ratio is Associated with Higher Cmax and AUC Despite Similar Pre-dose Concentrations. (PubMed, Clin Pharmacokinet) - "Tacrolimus C0 alone incompletely reflects the full pharmacokinetic profile and may miss clinically relevant peak-related toxicity. The C0/dose ratio may help identify patients with disproportionate exposure, in whom more individualized therapeutic drug monitoring beyond C0 monitoring is recommended."

Journal • Transplantation

Rapid Achievement of Target Tacrolimus Concentrations with Extended-Release Formulation: A Single-Center, Prospective, Open-Label, Randomized Controlled Study (ChiCTR) - P4 | N=118 | Recruiting | Sponsor: Southern Medical University Southern Hospital; Southern Medical University Southern Hospital

New P4 trial • Transplantation

Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: OHSU Knight Cancer Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

Tacrolimus intrapatient variability and latent virus reactivation after kidney transplantation: A retrospective study comparing prolonged-release and immediate-release tacrolimus formulations. (PubMed, J Int Med Res) - "Multivariate analysis confirmed an independent association between high tacrolimus intrapatient variability and cytomegalovirus reactivation.ConclusionsTacrolimus intrapatient variability may predict reactivation of latent viral infection after kidney transplantation. Although viral reactivation rates were similar between tacrolimus formulations, prolonged-release tacrolimus showed lower tacrolimus intrapatient variability levels, suggesting that fluctuations in tacrolimus exposure might increase the risk of viral reactivation."

Clinical • Journal • Observational data • Retrospective data • Cytomegalovirus Infection • Infectious Disease • Transplantation

Tacrolimus variability and medication adherence pre- and post-conversion from immediate-release to extended-release tacrolimus in pediatric solid organ transplant. (PubMed, Pediatr Transplant) - "Tac-SD decreased after conversion from IR-Tac to LCPT among those with high baseline variability but increased among those with low baseline variability; there were no significant changes in subjective adherence measures. The effectiveness of conversion from IR-Tac to LCPT for adherence is unclear."

Journal • Observational data • Retrospective data • Pediatrics • Solid Organ Transplantation • Transplantation

Evaluation of the Drug Drug Interaction Between Letermovir and Tacrolimus in Abdominal Transplant Recipients (ATC 2026) - "Eligible patients were those transitioned to letermovir while receiving immediate-release (IR) or extended-release (ER) tacrolimus (FK)...Letermovir was initiated at a dose of 480 mg once daily, at a median of 83 days (IQR 48-156) post-transplant, primarily due to leukopenia with valganciclovir therapy (91%)... Letermovir appears to be an effective prophylaxis option in non-kidney and R+ recipients. Based on these findings, a preemptive dose reduction of FK by 40% appears to be warranted when initiating letermovir in abdominal SOT recipients to mitigate drug interactions."

Clinical • Cytomegalovirus Infection • Hematological Disorders • Leukopenia • Solid Organ Transplantation • Transplantation

Tacrolimus Formulation, Switching Patterns, and Early Post-Transplant Healthcare Utilization Across Seven U.S. Transplant Centers (ATC 2026) - "*Purpose: To compare tacrolimus variability and healthcare utilization outcomes between patients who received extended-release tacrolimus (LCPT) as part of maintenance immunosuppression regimen and those who received immediate release (IR) tacrolimus therapy.* Longitudinal retrospective cohort study including adult abdominal transplant recipients at 7 U.S. transplant centers... Frequent switching between LCPT and IR tac may confer higher risk of immunosuppression variability and greater healthcare utilization."

HEOR • Late-breaking abstract • Post-transplantation • Transplantation

2022/0342/HP: Screening for subclinical antibody mediated rejection and efficacy of belatacept in the context of de novo donor specific antibody after kidney transplantation / BEL-AMR (clinicaltrialsregister.eu) - P3/4 | N=290 | Recruiting | Sponsor: Centre Hospitalier Universitaire Rouen | Not yet recruiting ➔ Recruiting

Enrollment open • Antibody-mediated Rejection • Transplantation

TRANSCEND: A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: VIVUS LLC

New P3 trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

9416: Immunosuppression regimen reduction in kidney transplantation recipients admitted to the intensive care unit in the setting of septic shock and/or acute respiratory failure: an open multicentric randomized phase IV study (clinicaltrialsregister.eu) - P2/3 | N=212 | Recruiting | Sponsor: Les Hopitaux Universitaires De Strasbourg | Not yet recruiting ➔ Recruiting

Enrollment open • Critical care • Respiratory Diseases • Septic Shock • Transplantation

Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • IFNG

Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft (clinicaltrials.gov) - P1 | N=66 | Active, not recruiting | Sponsor: Stanford University | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2027 ➔ May 2028 | Trial primary completion date: Nov 2027 ➔ May 2028

Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • Transplantation • HLA-B • HLA-C • HLA-DRB1

Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P2 trial • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • HLA-DRB1