tacrolimus oral / Generic mfg. - LARVOL DELTA

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

BGB-3111-309: A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy (clinicaltrials.gov) - P2/3 | N=178 | Active, not recruiting | Sponsor: BeOne Medicines | Recruiting ➔ Active, not recruiting | N=282 ➔ 178 | Trial completion date: Apr 2028 ➔ Oct 2027 | Trial primary completion date: Apr 2028 ➔ Oct 2027

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Glomerulonephritis • Renal Disease

Breaking Through the Mucosal Wall: Topical Tacrolimus for Refractory Esophageal Lichen Planus (ACG 2025) - "Over the subsequent months, the patient was trialed on approximately 12-week courses of the following: twice daily high-dose proton pump inhibitor (PPI), two different formulations of topical corticosteroids equivalent to budesonide 2 mg twice daily, oral tacrolimus 2 mg twice daily, and hydroxychloroquine 200 mg daily. Given the difficulty of treating refractory ELP, this case may provide clinicians with another medication that may be utilized when other therapies have failed.Figure: Figure 1: Initial endoscopic findings in the proximal (1a.), mid (1b.), and distal (1c.) esophagus and histopathology demonstrating lymphocyte predominant esophagitis with dyskeratotic cells (1d,1e,1f)Figure: Figure 2. Follow up endoscopic findings after 3 months of esophageal suspension tacrolimus (2a, 2b)"

Dermatology • Dermatopathology • Gastrointestinal Disorder • Gynecology • Hodgkin Lymphoma • Inflammation • Lichen Planus

Unmasking the Diarrhea: A Case of Mycophenolate-Induced Colitis in a Renal Transplant Patient with Crohn's Disease and History of CMV Viremia (ACG 2025) - "Introduction: Diarrhea is a common side effect of mycophenolate mofetil in solid organ transplant patients and mycophenolate-induced colitis in this population is well-described...We describe a case of diarrhea in a renal transplant patient with Crohn's disease and recent CMV viremia initially obscuring diagnosis.Case Description/ A 68-year-old male with history of Crohn's disease, renal transplant in 2023, and prior cytomegalovirus (CMV) viremia on valganciclovir presented with watery diarrhea for several weeks...He reported adherence to his immunosuppressants including oral tacrolimus 5 mg daily, mycophenolate 720 mg bid, and prednisone 5 mg daily...Immunohistochemical staining was negative for CMV.Mycophenolate was discontinued and Azathioprine initiated...Clinicians should have a high index of suspicion for mycophenolate-induced colitis in transplant recipients and perform colonoscopy early to aid in prompt diagnosis.Figure: Figure 1: Histopathology slides of..."

Clinical • Acute Kidney Injury • Crohn's disease • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Nephrology • Solid Organ Transplantation • Transplantation

Refractory Esophagitis and Stricture Mistreated With Fundoplication: Think About Lichen Planus (ACG 2025) - "She started on low dose oral tacrolimus and endoscopic steroid injection.Case 2: A 66-year-old female was referred for refractory esophageal stricture and dysphagia without reflux symptoms...Despite one month budesonide and daily dexlansoprazole, symptoms and inflammation persisted, requiring monthly dilations...Figure 2B. Repeat endoscopy revealed diffuse mucosal abnormalities including sloughing, altered texture, decreased vascularity, and a uniformly narrow caliber esophagus."

Dermatology • Dermatopathology • Gastroenterology • Gastrointestinal Disorder • Inflammation • Lichen Planus

Safety and Efficacy of LP-10 Liposomal Tacrolimus in Oral Lichen Planus: A Multicenter Phase 2 Trial. (PubMed, Dermatol Ther (Heidelb)) - P2 | "LP-10 demonstrated excellent safety with minimal systemic absorption and clinically meaningful efficacy, representing substantial improvement over existing therapies for this serious condition with significant unmet medical need. Larger controlled studies are warranted to confirm these promising findings."

Journal • P2 data • Dermatology • Dermatopathology • Lichen Planus • Pain

Medical Management of an Infusion Site Extravasation Injury After Peripheral Intravenous Infusion of Ado-Trastuzumab Emtansine in a 38-Year-Old Woman with Breast Cancer: A Case Report. (PubMed, Am J Case Rep) - "She was treated with a topical steroid (clobetasol), topical calcineurin inhibitor (tacrolimus), oral antibiotic (cefadroxil), high-dose vitamin D (ergocalciferol), and pain management (gabapentin) with almost complete resolution in 4 weeks. CONCLUSIONS This case report describes a T-DM1 skin extravasation treated with multimodal medical measures as opposed to a more conservative approach. We reaffirm that the use of port access when administering T-DM1 is critical to prevent extravasation, and we recommend multimodal management, including antibiotics and topical therapies, to prevent infection and expedite wound healing if extravasation occurs."

Journal • Breast Cancer • Dermatology • Hormone Receptor Breast Cancer • Infectious Disease • Oncology • Pain • Solid Tumor

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: Jan 2026 ➔ May 2026 | Trial primary completion date: Aug 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Transplantation

Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) - P2 | N=31 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Phase classification: P1 ➔ P2

Phase classification • Graft versus Host Disease • Hematological Disorders • Immunology

Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2025 ➔ Sep 2026

Checkpoint inhibition • Trial completion date • Basal Cell Carcinoma • Colorectal Cancer • Cutaneous Melanoma • Melanoma • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation • BRAF • MSI

Severe Gastroduodenitis Associated With Ulcerative Colitis After Total Colectomy Successfully Treated With Endoscopic Hemostasis and Oral Tacrolimus. (PubMed, DEN Open) - "Oral tacrolimus was initiated because the inflammation was steroid-resistant. Approximately 2 weeks after the initiation of tacrolimus, abdominal symptoms, including bloody diarrhea, disappeared, and EGD showed improvement in the GDUC."

Journal • Anorexia • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pain • Peptic Ulcer • Ulcerative Colitis • CRP

Influence of the gut microbiota on the pharmacokinetics of tacrolimus in liver transplant recipients: insights from microbiome analysis. (PubMed, Front Microbiol) - "Patients were stratified into three groups on the basis of oral tacrolimus dosage and blood concentration: LDLBC (low dose, low blood concentration), LDHBC (low dose, high blood concentration), and SDLBC (standard dose, low blood concentration)...Additionally, antibiotic resistance genes were more abundant in patients with lower tacrolimus blood concentrations, particularly in the Escherichia coli-enriched groups. These findings underscore the influence of the gut microbiota on tacrolimus pharmacokinetics and support the potential of microbial composition as a biomarker for optimizing immunosuppressive therapy."

Journal • PK/PD data • Transplantation

SUPERIOR BIOAVAILABILITY OF TACROLIMUS IN LIVER TRANSPLANT RECIPIENTS TREATED WITH EXTENDED-RELEASE LCP-TACROLIMUS (ENVARSUS) COMPARED TO PROLONGED-RELEASE TACROLIMUS (ADVAGRAF) AFTER 12 WEEKS OF CONTROLLED THERAPY WITHIN A MULTICENTRE, RANDOMISED, CONTROLLED CLINICAL TRIAL ("ENGRAFT") (AASLD 2025) - "Background: Oral tacrolimus formulations exhibit low and variable bioavailability, leading to high dose requirements and dose-dependent toxicities. For the first time in liver transplantation, superior bioavailability of LCPT has been unequivocally demonstrated in a large, multicentre, prospective study statistically powered to test the C/D ratio as a primary endpoint. After the last study visit in October 2026, the final analysis will reconcile drug pharmacokinetics with long-term efficacy and safety data."

Clinical • Movement Disorders • Transplantation

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

Combined impact of rituximab and target care on efficacy, quality of life, adverse reactions and recurrence rate in children with nephrotic syndrome: a randomized controlled trial. (PubMed, BMC Pediatr) - P=N/A | "The rituximab-based regimen combined with target care exhibited beneficial outcomes by effectively improving clinical efficacy and reducing recurrence for children with nephrotic syndrome, with a safety profile comparable to a tacrolimus-based regimen over the study period. Quality of life improved in both groups. Further studies with longer follow-up are needed to assess long-term outcomes and safety."

HEOR • Journal • Glomerulonephritis • Hematological Disorders • Nephrology • Neutropenia • Pediatrics • Renal Disease

Case series: Effectiveness and safety of dupilumab for liver transplant recipients in paediatric patients with eczema (EADV 2025) - "This type of eczema is highly symptomatic and patch testing to topical tacrolimus has been reported to be negative...He was immunosuppressed with mycophenolate mofetil and oral tacrolimus from age 2...Case 4: 7-year-old boy of skin type 6 with a liver transplant age 1 year for biliary atresia and secondary portal hypertension and a history of ITP needing IVIG and rituximab... Our case series highlights that in line with other case series, Dupilumab is a safe and effective treatment. Our cohort of paediatric patients with severe eczema have had liver transplantations and thus have had no live vaccines throughout childhood. We report no side effect sequelae at present."

Clinical • Atopic Dermatitis • Cardiovascular • Dermatology • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Liver Failure • Pediatrics • Portal Hypertension • Pruritus • Thrombosis • Transplantation

Establishment of a canine model of vascularized allogeneic spinal cord transplantation and preliminary study on spinal cord continuity reconstruction (PubMed, Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi) - "The experimental group received immunosuppressive intervention with oral tacrolimus [0.1 mg/(kg∙d)] postoperatively, while the control group received no treatment...This surgical procedure can restore the continuity of the spinal cord. The combination of tacrolimus anti-immunity is a key factor for the success of transplantation."

Journal • Preclinical • Cardiovascular • CNS Disorders • Orthopedics • Reperfusion Injury • Transplantation

Acute Pancreatitis Associated with Tacrolimus in A Lung Transplant Recipient: A Case Report and Review of Literature. (PubMed, Eur J Case Rep Intern Med) - "Tacrolimus related complications including metabolic changes are commonly observed.Development of acute pancreatitis is one of the rare complications of tacrolimus therapy, seldomly reported in transplant recipients.The definitive therapeutic approach is still to be determined."

Journal • Critical care • Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Pancreatitis • Transplantation