tacrolimus intravenous / Generic mfg. - LARVOL DELTA

LEGACY: Phase 3 Randomized Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation (clinicaltrials.gov) - P3 | N=620 | Not yet recruiting | Sponsor: Eledon Pharmaceuticals

New P3 trial • Immunology • Transplant Rejection • Transplantation

NCI-2018-01752: Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2 | N=45 | Active, not recruiting | Sponsor: Fred Hutchinson Cancer Center | Recruiting ➔ Active, not recruiting | N=68 ➔ 45

Enrollment change • Enrollment closed • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Burkitt Lymphoma • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Mast Cell Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-B • HLA-C • HLA-DRB1

Systematic review and network meta-analysis for the 2026 update of the evidence-based clinical practice guidelines for the management with immunosuppressive therapies and biologic agents of membranous nephropathy. (PubMed, Clin Exp Nephrol) - "Treatment effects differed across interventions, but the overall certainty of the evidence was limited, highlighting the need for well-designed, adequately powered randomized trials with standardized methodologies."

Clinical guideline • Journal • Retrospective data • Glomerulonephritis • Infectious Disease • Nephrology • Renal Disease

Impact of tacrolimus trough intra-patient variability on donor-derived cell-free DNA and clinical outcomes (TTS 2026) - "Introduction: High intra-patient variability in tacrolimus (Tac-IPV) has been associated with rejection, de novo DSA formation, and graft failure, but its clinical utility is limited by logistical challenges in obtaining multiple trough concentrations over a prolonged period... High Tac-IPV, especially with underexposure, is associated with elevated dd-cfDNA and adverse outcomes. These findings support the role of dd-cfDNA surveillance in identifying KTR at increased risk and refining tacrolimus-based risk stratification in the setting of under-immunosuppression."

cfDNA • Clinical • Clinical data

Immunosuppressive drugs and calcium supplementation may be coadministered in kidney transplant recipients (TTS 2026) - "Theoretically tacrolimus (Prograf®) may experience similar interaction. Concomitant administration of mycophenolate mofetil and calcium supplementation showed a minor, but not clinically relevant, decrease in AUC0-12. A moderate decrease in Cmax and increase in Tmax can be explained by a somewhat reduced absorption rate. No relevant alterations of tacrolimus pharamcokinetics were observed with concomitant calcium supplementation."

Clinical • Transplantation

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

Clinical significance of intra-patient tacrolimus variability and tacrolimus exposure in older kidney transplant recipients (TTS 2026) - " This retrospective cohort study included adult kidney transplant recipients (≥18 years) from 2006 to June 2023, stratified into four groups based on 1-year tacrolimus trough levels and IPV: 1) low tacrolimus(<4ng/ml) /low IPV(<30%), 2) high tacrolimus (≥4ng/ml)/low IPV(<30%), 3) low tacrolimus(<4ng/ml) /high IPV(≥30%), and 4) high tacrolimus (≥4ng/ml)/ high IPV(≥30%)... This study highlights age-specific differences in the clinical significance of tacrolimus exposure and IPV. Reducing IPV and careful optimization of tacrolimus exposure for older kidney transplant recipients are critical to improving graft outcomes. These findings underscore the need for tailored immunosuppressive strategies in this population."

Clinical • Transplantation

BAP-Tac (BuccomucoAdhesive Patch-based Tacrolimus) Delivery System: The Next-Generation of Tacrolimus Administration (TTS 2026) - "Since intravenous tacrolimus is not available in India, the clinician must switch to injectable cyclosporine-A in patients with the above clinical profile in the absence of an alternative. Compared to oral treatment, the Bap-Tac provides greater and extended drug bioavailability, with the potential to reduce the oral dose by half. These results suggest that Bap-Tac is a feasible alternative to intravenous tacrolimus administration that could help therapeutic orphans with a functioning allograft, improving patient outcomes. Schematic Presentation of BuccomucoAdhesive Patch of TacrolimusIn-vivo Pharmacokinetics of BAP-Tac compared to Oral Tacrolimus in New Zealand White Rabbits"

Candidiasis • Gastrointestinal Disorder

Correlation of Tacrolimus trough levels with Graft events in Renal Transplant Recepients – An Ambispective Study (TTS 2026) - "This study evaluated the association of tacrolimus trough levels, intra-patient variability (IPV), and tacrolimus genotype with graft events in renal transplant recipients... Higher tacrolimus exposure is strongly associated with post-transplant infection, whereas intra-patient trough variability shows limited predictive value for rejection. Pharmacogenetic variability contributes to tacrolimus exposure and infection risk, supporting the potential role of genotype-guided dosing and individualized immunosuppression strategies to optimize transplant outcomes."

Infectious Disease • Nephrology • Transplant Rejection • Transplantation

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 as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia (clinicaltrials.gov) - P2 | N=33 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Jun 2026 ➔ May 2027 | Trial primary completion date: Jun 2026 ➔ May 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • FLT3 • HLA-DRB1

A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Astellas Institute for Regenerative Medicine | Trial completion date: Jun 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Monitoring Long-term Tacrolimus Exposure: Metrics, Trajectories, and Associations with Outcomes after Kidney Transplantation in the Wisconsin Allograft Recipient Database (WisARD). (PubMed, Am J Nephrol) - "Cumulative high tacrolimus IPV in the past 5 years was associated with higher risk of graft failure and mortality. Conclusion Metrics of tacrolimus exposure assessed beyond the first year after kidney transplantation, especially IPV, remain informative for long-term outcomes."

Journal • Transplantation

A Rare Case of Extramedullary Plasmacytoma of the Colon in an Immunocompromised Patient (ACG 2026) - "Case Description/ A 60 yo F patient with hx of DDRT(11/2006) ( On tacrolimus and prednisone; previously on Prograf, transitioned 6 months ago), HTN, Hypothyroidism, Anemia, DVT/PE and Afib on Eliquis presented to GI clinic for routine screening colonoscopy. Figure: Image demonstrating sessile polyps in the transverse and descending colon. Figure: Pathology image demonstrating a plasma cell with positive Kappa in Immunohistochemical staining"

Clinical • Colonic Polyps • Constipation • Endocrine Disorders • Epstein-Barr Virus Infections • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immunology • Multiple Myeloma • Plasmacytoma • SDC1

Debut of Gastric Schwannoma in THSD7A-Positive Membranous Nephropathy (ACG 2026) - "This included rituximab, tacrolimus, and intravenous immunoglobulin. A peripheral hypoechoic halo corresponding to lymphoid cuffing is seen in up to half of cases and may help distinguish schwannoma from GIST. Internal calcifications and cystic degeneration are uncommon, and lesions generally demonstrate smooth borders with intraluminal or extraluminal growth patterns."

Brain Cancer • Dyslipidemia • Glomerulonephritis • Lupus Nephritis • Nephrology • Renal Disease • Solid Tumor • ANO1 • KIT

Successful Therapeutic Plasma Exchange in Refractory Anti-MDA5-Positive Dermatomyositis and Rapidly Progressive-Interstitial Lung Disease: A Case Report. (PubMed, Turk J Anaesthesiol Reanim) - "This report discusses a 60-year-old female patient diagnosed with anti-MDA5-positive CADM who developed RP-ILD that was resistant to pulse steroid therapy, tacrolimus, and intravenous immunoglobulin...Following four sessions of TPE administered on alternate days, significant clinical and laboratory improvements were observed. This case underscores the potential life-saving impact of early TPE for patients with anti-MDA5-positive CADM and RP-ILD who do not respond to traditional immunosuppressive treatments."

Journal • Dermatomyositis • Immunology • Interstitial Lung Disease • Myositis • Pulmonary Disease • Respiratory Diseases • IFIH1

Ofatumumab Treatment for Refractory Generalized Myasthenia Gravis Post-Lung Adenocarcinoma Resection: A Case Report and Mechanistic Insight. (PubMed, Immun Inflamm Dis) - "This case highlights ofatumumab's potential efficacy and safety in managing refractory gMG post-cancer resection, possibly via robust B-cell depletion and reduced immunogenicity. These findings advocate for targeted B-cell therapies as a viable strategy in complex, refractory MG cases, particularly where conventional immunosuppressants pose oncological concerns."

Journal • CNS Disorders • Immunology • Lung Adenocarcinoma • Lung Cancer • Myasthenia Gravis • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

TacroProph: Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis (clinicaltrials.gov) - P4 | N=520 | Not yet recruiting | Sponsor: Amsterdam UMC, location VUmc

New P4 trial • Pancreatitis

Unlocking the impact of BK virus in renal transplant recipients in North India: viral load dynamics, genotypes, and clinical outcomes. (PubMed, Transpl Immunol) - "In this exploratory study, higher recent tacrolimus exposure was associated with BKPyV positivity and viral load, supporting individualized immunosuppression management and routine BKPyV surveillance in kidney transplant recipients."

Clinical data • Journal • Infectious Disease • Nephrology • Transplant Rejection • Transplantation

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

ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Northwestern University | Trial completion date: Aug 2028 ➔ Aug 2029 | Trial primary completion date: Dec 2027 ➔ Dec 2028

Trial completion date • Trial primary completion date • Transplant Rejection • 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

Improvement of Refractory Cutaneous Ulcers and Pulmonary Arterial Hypertension Following Rituximab and Mycophenolate Mofetil Therapy in Anti-melanoma Differentiation-Associated Gene 5 (Anti-MDA5) Antibody-Positive Dermatomyositis. (PubMed, Cureus) - "Despite the escalation of immunosuppressive therapy with glucocorticoids, tacrolimus, intravenous immunoglobulin, and cyclophosphamide, the cutaneous ulcers remained refractory. Bosentan was discontinued, and azathioprine was initiated to maintain remission, allowing for a successful pregnancy and delivery of a healthy infant. This case suggests a potential role for an MMF- and RTX-containing combination regimen in refractory cutaneous ulcers and PAH associated with anti-MDA5 DM."

Journal • Cardiovascular • Dermatomyositis • Hypertension • Immunology • Melanoma • Myositis • Oncology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Rheumatology • Solid Tumor • IFIH1