tacrolimus oral / Generic mfg. - LARVOL DELTA

Tacrolimus Dosing for Graft Versus Host Disease (GVHD) Prevention in Bone Marrow Transplant Patients (HOPA 2026) - "Objectives:The primary objective of this study is to determine the IV:PO tacrolimus conversion ratio that most consistently achieves tacrolimus therapeutic serum concentrations in pediatric HSCT patients. Pending results."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Transplantation

Effect of High-Fat Diet on Pharmacokinetics and Incidence of Adverse Reactions of Tacrolimus in Healthy Chinese Participants. (PubMed, Clin Pharmacol Drug Dev) - "The effects of food on the pharmacokinetics (PKs) and safety of 1 mg Tacrolimus sustained-release Tacrolimus capsules in healthy Chinese subjects were investigated from one bioequivalence trial...The incidence of adverse events (AEs) was similar between the fasted and fed states, and no serious AEs were observed. Fasting significantly increased the exposure of Chinese subjects to 1 mg Tacrolimus."

Clinical • Journal • PK/PD data

The Bi-steric, mTORC1-Selective Inhibitor, RMC-5552, in Advanced Solid Tumors: A Phase 1 Trial. (PubMed, Clin Cancer Res) - P1 | "The success of TM-mediated prophylaxis and the clearance of selected variants in ctDNA are concordant with selective, on-mechanism, antitumor activity following RMC-5552 treatment. These data show that RMC-5552, the first bi-steric mTORC1-selective inhibitor in the clinic, is active at tolerable doses, and that selective inhibition of mTORC1 alleviates mTORC2-mediated hyperglycemia, overcoming a key limitation of prior mTOR inhibitors."

Journal • P1 data • Diabetes • Endometrial Cancer • Fatigue • Mucositis • Oncology • Solid Tumor • Stomatitis • EIF4EBP1 • PIK3CA • PTEN

RC24-0546: IL-1? blockade to prevent Immunothrombosis in recipients of a Pancreatic Organ (ILIPO) (clinicaltrialsregister.eu) - P1/2 | N=15 | Not yet recruiting | Sponsor: Centre Hospitalier Universitaire De Nantes

New P1/2 trial • Diabetes • Hematological Disorders • Metabolic Disorders • Thrombosis • Transplantation

Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904) (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Fred Hutchinson Cancer Center | Active, not recruiting ➔ Completed

Trial completion • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Complement-mediated Rare Disorders • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Neutropenia • Oncology • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Thrombocytopenia • Transplantation • GATA2 • HLA-B • HLA-C • HLA-DQB1 • HLA-DRB1

Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects (clinicaltrialsregister.eu) - P4 | N=100 | Recruiting | Sponsor: Oslo University Hospital HF | Not yet recruiting ➔ Recruiting

Enrollment open • Transplantation

CalciTx: CALCIGRAN FORTE AND DOSING OF IMMUNOSUPPRESSIVE DRUGS IN KIDNEY TRANSPLANT RECIPIENTS (clinicaltrialsregister.eu) - P4 | N=26 | Completed | Sponsor: Oslo University Hospital HF | Not yet recruiting ➔ Completed

Trial completion • Transplantation

GenIS-BID: Immunosuppressive drug bioequivalence in kidney transplant recipients Prograf and CellCept (clinicaltrialsregister.eu) - P4 | N=27 | Completed | Sponsor: Oslo University Hospital HF | Not yet recruiting ➔ Completed

Trial completion • Transplantation

Tacrolimus Dosing Optimization for Allogeneic Transplant Patients Receiving Post-Transplant Cyclophosphamide (TCT-ASTCT-CIBMTR 2026) - "al 2023) compared methotrexate plus a calcineurin inhibitor to a novel regimen consisting of post-transplant cyclophosphamide (PT-Cy), tacrolimus, and mycophenolate mofetil (MMF)...Oral versus intravenous bioavailability, body mass index (BMI) related variability, and drug-drug interactions (notably with posaconazole) further complicate dosing... Data trends will be analyzed and presented for patients receiving Pt-Cy and oral tacrolimus from January through December 2025. 1 . Identify clinical and drug-related factors that impact tacrolimus levels."

Clinical • Post-transplantation • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Transplantation

Evaluating the IV-to-PO Conversion Ratio of Intermittent IV Bolus Tacrolimus in Pediatric Allogeneic HCT (TCT-ASTCT-CIBMTR 2026) - "In pediatric HCT patients receiving twice-daily IV bolus tacrolimus, an IV-to-PO conversion ratio of approximately 1:3 achieved therapeutic levels with minimal toxicity. These findings suggest that lower conversion ratios than those previously published for continuous infusion may be appropriate and warrant validation in larger, prospective studies. 1."

Clinical • Acute Graft versus Host Disease • Acute Kidney Injury • Graft versus Host Disease • Immunology • Nephrology • Pediatrics • Renal Disease

Exposure-Response: Tacrolimus Dosing and Acute Graft Versus Host Disease in Allogeneic Hematopoietic Cell Transplant Recipients (TCT-ASTCT-CIBMTR 2026) - "However, despite the use of therapeutic drug monitoring, the optimal tacrolimus dosing strategy in allo-HCT that associates with improved aGVHD outcomes has remained elusive, and a direct exposure- response relationship between oral tacrolimus Ctrough,ss and clinically significant grade II-IV aGVHD is still poorly characterized...3. Evaluate the potential clinical impact of model-informed dosing strategies on aGVHD prevention."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Transplantation • CYP3A5

Integrated metabolomics and proteomics analysis elucidated the therapeutic effect of Huangkui Capsule on tacrolimus-induced chronic nephrotoxicity in rats. (PubMed, J Ethnopharmacol) - "HK attenuated TCN through suppression of ferroptosis, as demonstrated by integrated metabolomic and proteomic analyses. This protective effect was mediated by its bioactive components, specifically quercetin, tamarixetin, and quercetin-7-O-β-glucuronide, which enhanced GSH synthesis and inhibited lipid peroxidation via upregulation of Slc7a11/Slc3a2 system."

Journal • Preclinical • Chronic Kidney Disease • Inflammation • Nephrology • Renal Disease • GPX4 • SLC3A2 • SLC7A11

Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders (clinicaltrials.gov) - P2 | N=31 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Aplastic Anemia • Follicular Lymphoma • Hematological Malignancies • Metabolic Disorders • Myelodysplastic Syndrome • Myelofibrosis • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • KMT2A

TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Stanford University

New P1 trial • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Myelofibrosis • Oncology • Transplantation

Off-the-shelf NK Cells + SCT for Myeloid Malignancies (clinicaltrials.gov) - P2 | N=24 | Completed | Sponsor: M.D. Anderson Cancer Center | Phase classification: P1/2 ➔ P2

Phase classification • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • ABL1 • ASXL1 • BCR • DEK • FLT3 • GATA2 • KMT2A • MECOM • NPM1 • NUP214 • RUNX1 • TP53

SIMPLE: Envarsus XR Compared to Immediate Release Tacrolimus (clinicaltrials.gov) - P4 | N=261 | Completed | Sponsor: Mayo Clinic | Active, not recruiting ➔ Completed

Trial completion • Transplantation

NCI-2018-01607: Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P1/2 | N=74 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

Orelabrutinib for elderly patients with stage IV marginal zone lymphoma involving the central nervous system: A case report and clinical implications (ASH 2025) - "The patient was ultimately diagnosed with mild generalized myasthenia gravis and initiated on oral tacrolimus therapy; however, no significant improvement in bilateral eyelid ptosis was observed. This case describes a rare instance of MZL with multiple extranodal involvement and CNS invasion. Its diagnostic process, therapeutic course, and outcomes carry significant reference value for the clinical management of MZL with CNS involvement. Regarding treatment, the R-miniCHOP regimen partially controlled systemic lesions, while intrathecal injections were administered to specifically clear CNS lesions."

Case report • Clinical • Metastases • CNS Disorders • Hematological Malignancies • Ischemic stroke • Lymphoma • Marginal Zone Lymphoma • Myasthenia Gravis • Myelofibrosis • Non-Hodgkin’s Lymphoma

Safety and activity of gene therapy with AAV8 GBA1 (LY-M001)on type I adults gaucher disease (ASH 2025) - P=N/A | "After one week of prophylactic prednisone (1 mg/kg/day),participants received a single intravenous infusion of LY-M001 at either 5×10¹² vg/kg (Cohort 1, n=1) or1.5×10¹³ vg/kg (Cohort 2, n=2)...In Cohort 2, one patient had transient ALTelevations (peak 96 IU/L) and delayed mild elevation (ALT 73 IU/L), managed with oral tacrolimus...This pilot study suggests that LY-M001 is well tolerated up to 21 months post-infusion, with encouragingbiochemical and clinical responses observed in the medium-dose cohort. LY-M001 holds potential as apromising gene therapy alternative to current GD treatments, addressing key unmet clinical needs."

Clinical • Gene therapy • Gaucher Disease • Gene Therapies • Genetic Disorders • Metabolic Disorders • Type 1 Gaucher Disease • GBA • GBA1

PA20 Case series: effectiveness and safety of dupilumab for liver transplant recipients in paediatric patients with eczema. (PubMed, Br J Dermatol) - "He was immunosuppressed with mycophenolate mofetil and oral tacrolimus from age 2 years...Case 4 is a 7-year-old boy with skin type VI with a liver transplant age 1 year for biliary atresia and secondary portal hypertension, and a history of immune thrombocytopenia needing intravenous immunoglobulin and rituximab...Our cohort of paediatric patients with severe eczema had liver transplantations and thus had no live vaccines throughout childhood. We report no side-effect sequelae at present."

Journal • Atopic Dermatitis • Cardiovascular • Dermatology • Hematological Disorders • Hepatology • Hypertension • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Inflammation • Pediatrics • Portal Hypertension • Thrombocytopenia • Thrombocytopenic Purpura • Thrombosis • Transplantation

An Adolescent Case of Ulcerative Colitis Complicated by Toxic Megacolon. (PubMed, Case Rep Gastroenterol) - "In this patient, the condition was initially controlled with steroid pulse therapy followed by oral tacrolimus. However, due to an inadequate response, treatment was escalated to infliximab (IFX), leading to remission and successful avoidance of surgical intervention. When opting for conservative treatment of UC complicated by toxic megacolon, intensive steroid pulse, tacrolimus, and IFX therapy should be considered as a potentially effective treatment option."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Precisely Controlled Long-Acting Immunosuppression Platform Enables Prolonged Survival of Vascularized Composite Allografts. (PubMed, bioRxiv) - "Oral tacrolimus (TAC) is limited by a narrow therapeutic window, pharmacokinetic variability, adherence challenges, and toxicity...Notably, rapamycin (RAPA) served dually as an mTOR inhibitor and a TAC-binding excipient, enabling synchronized dual-agent delivery...PRECISE is, to our knowledge, the first retrievable, injectable platform to deliver long-acting, dual-agent immunosuppression with controlled kinetics, rapid attainment of therapeutic steady state, and sustained graft protection. Its modular, structure-guided design enables clinical translation across VCA and solid-organ transplantation, delivering precise, durable, and safer immunosuppression."

Journal • Solid Organ Transplantation • Transplantation

Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia (clinicaltrials.gov) - P2 | N=72 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Oct 2025 ➔ Sep 2026

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • HLA-B • HLA-C

Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial (KIDNEY WEEK 2025) - P2 | "All received rabbit anti-thymocyte globulin as induction, corticosteroids, and mycophenolate. Patients were randomized 1:1 to intravenous tegoprubart 20 mg/kg on days 1, 3, 7, 14, 21, 28, and every 21 days thereafter, or twice daily oral tacrolimus at a target whole blood trough concentration of 6–12 ng/mL to month 6, and 6–8 ng/mL thereafter...Initial efficacy and safety results at 12 months will be presented. Conclusion The results of the BESTOW study may provide a basis for continuing the development of tegoprubart as a potential alternative to tacrolimus for preserving allograft function and preventing kidney transplant rejection."

Clinical • Late-breaking abstract • P2 data • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Hypertension • Immunology • Metabolic Disorders • Movement Disorders • Nephrology • Transplant Rejection • Transplantation • CD40LG

PROMINENT: An Open-Label, Randomized Phase 3 Trial of Felzartamab in Primary Membranous Nephropathy (KIDNEY WEEK 2025) - P3 | "PROMINENT (NCT06962800) is an open-label, multicenter, randomized Phase 3 study in which 180 adults with newly diagnosed or relapsed biopsy-confirmed PMN in need of immunosuppressive therapy will be randomized to IV felzartamab or oral tacrolimus in protocol-specified dosing regimens. Participants who experience worsening kidney function or proteinuria, relapse, or do not improve on assigned treatment can receive rescue treatment. PROMINENT is the first Phase 3 trial evaluating the targeting of CD38 + plasma cells and plasmablasts in PMN to reduce proteinuria and preserve kidney function, which may address an unmet need in a disease with no approved therapies."

Clinical • P3 data • Glomerulonephritis • Immunology • Nephrology • Renal Disease