tacrolimus oral / Generic mfg. - LARVOL DELTA

Lower Gastrointestinal Involvement in Adult-Onset NXP2 Antibody-Positive Dermatomyositis (ACG 2026) - "He was treated with intravenous solumedrol with overall improvement...The patient was initially trialed on adalimumab with adequate control of his muscular and GI symptoms, but developed anti-therapeutic antibodies leading to secondary non-response. Thereafter, he continued to have suboptimal control of his disease on multiple therapies including intravenous immunoglobulin and tofacitinib. Currently, he is followed closely by his GI and rheumatology providers on oral tacrolimus...Management of these symptoms is largely empiric, with Janus kinase inhibitors and vedolizumab emerging as promising treatment options...Colonoscopic findings. Patchy moderate inflammation was found in the entire examined colon, including (A) ascending colon, (B) transverse colon, (C) descending colon, and (D) sigmoid colon."

Clinical • Dermatitis • Dermatomyositis • Gastroenterology • Gastrointestinal Disorder • Immunology • Myositis • Peptic Ulcer • Vasculitis • CRP

A Rare Case of Lichenoid Esophagitis in a Patient With Comorbid Leukocytoclastic Vasculitis and Antiphospholipid Syndrome (ACG 2026) - "Prior therapies including omeprazole, rabeprazole, oral budesonide, systemic prednisone, topical fluticasone, methotrexate, and dapsone were reported to be ineffective...Due to concerns for steroid-related complications, the patient was transitioned to oral tacrolimus 1 mg twice a day...While the predominant mechanisms of autoimmunity differ, this case suggests a possible association between LE and comorbid LCV and/or APS which warrants further investigation. Figure: Image 1: Esophageal stenosis of proximal esophagus 15 cm from the incisors found on baseline EGD in December, 2024 Figure: Image 2: Esophageal stenoses (narrowest 8 mm inner diameter by 1 cm length) found on EGD in September, 2025"

Clinical • Alopecia • Dermatomyositis • Dermatopathology • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Hematological Disorders • Immunology • Inflammatory Arthritis • Lichen Planus • Metabolic Disorders • Myositis • Sjogren's Syndrome • Type 1 Diabetes Mellitus • Vasculitis

Phase 2 BESTOW trial and the BESTOW EXTENSION: Evaluating the long-term safety and efficacy of tegoprubart in preventing kidney transplant rejection (TTS 2026) - P2 | "Patients received i.v. tegoprubart 20 mg/kg on days 1, 3, 7, 14, 21, 28, then every 21 days, or oral tacrolimus twice daily. BESTOW supports continued development of tegoprubart as a potential alternative to tacrolimus for preserving kidney transplant function and preventing rejection."

Clinical • P2 data • Diabetes • Immunology • Infectious Disease • Metabolic Disorders • Movement Disorders • Transplant Rejection • Transplantation • CD40LG

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

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

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

BRAVE: Budesonide versus prednisolone after liver transplantation: a phase 3, open label, non-inferiority randomised controlled trial (ANZCTR) - P3 | N=105 | Active, not recruiting | Sponsor: Austin Health | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Transplant Rejection • Transplantation

A comparative study on the efficacy of rituximab combined with tacrolimus and methylprednisolone in the treatment of patients with moderate-high risk idiopathic membranous nephropathy. (PubMed, Am J Transl Res) - "After adjusting for confounding factors such as age, diabetes, and baseline renal function, concurrent rituximab and methylprednisolone showed a more favorable therapeutic outcome compared to the tacrolimus regimen, and it was applicable to a wider range of patients."

Journal • Diabetes • Glomerulonephritis • Metabolic Disorders • Renal Disease

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

Ketogenic Diet-Mediated Immunomodulation for Prevention of Epilepsia Partialis Continua in Rasmussen's Encephalitis: Review and Case Study. (PubMed, Case Rep Neurol) - "Immunotherapy with oral tacrolimus was initiated, resulting in stabilization of cognitive decline and reduction of seizure frequency from approximately 30-40 to 15-20 episodes per day...These findings suggest that ketogenic dietary therapy may represent a promising adjunctive therapeutic strategy alongside immunomodulatory treatment in this rare and challenging condition. Further studies are needed to clarify its role in disease progression and seizure control."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy • Immunology • Pediatrics

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

Enrollment open • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Myelofibrosis • Oncology • Transplantation • HLA-B • HLA-C • HLA-DRB1

Differential Oral Absorption Pharmacokinetics of Tacrolimus in Simultaneous Kidney-Pancreas Transplant Compared to Kidney Transplant Recipients. (PubMed, Clin Pharmacokinet) - "We successfully developed two separate population PK models for tacrolimus in SPK and KT recipients together with a combined SPK and KT model, showing a significantly reduced tacrolimus oral absorption rate in SPK recipients. In addition, our data suggested that SPK recipients might need higher C0 target concentrations to obtain a similar tacrolimus exposure as KT recipients."

Journal • PK/PD data • Chronic Kidney Disease • Diabetes • Gastrointestinal Disorder • Metabolic Disorders • Nephrology • Renal Disease • Transplantation • Type 1 Diabetes Mellitus

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

PROMINENT: A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN) (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Biogen | Trial completion date: Mar 2029 ➔ Jan 2031 | Trial primary completion date: Dec 2028 ➔ Jan 2030

Trial completion date • Trial primary completion date • Glomerulonephritis • Renal Disease

Tacrolimus Modulates Peripheral Blood NK Cell Subsets and IL-17/IL-10 Ratio in Women With Recurrent Implantation Failure. (PubMed, Reprod Med Biol) - "Patients received oral tacrolimus (3 mg/day) before embryo transfer until pregnancy testing...Greater reductions in the IL-17/IL-10 ratio were associated with clinical pregnancy (p = 0.048), suggesting predictive value for implantation success. Tacrolimus modulated immune pathways by reducing pro-inflammatory NK subsets and shifting the IL-17/IL-10 balance toward tolerance, supporting its potential as targeted immunotherapy in selected patients."

IO biomarker • Journal • Immunology • IL10 • IL17A • NCAM1

TEAMMATE: Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score (clinicaltrials.gov) - P3 | N=211 | Completed | Sponsor: Boston Children's Hospital | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Chronic Kidney Disease • Infectious Disease • Nephrology • Pediatrics • Renal Disease • Transplant Rejection • Transplantation

suNR1se II: CC-101 (f/k/a NR1) Neural Stem Cell Transplantation for Adults With Chronic Ischemic Stroke (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Clarion Cells, Inc.

New P2 trial • Cardiovascular • Ischemic stroke • Transplantation

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

Retrospective Study of Cases After Induction Therapy with Tacrolimus in Our Hospital (AOCC-IMKASID 2026) - "Background / Aim: Oral tacrolimus is approved as induction therapy for steroid-resistant refractory ulcerative colitis (UC)...Maintenance therapy after tacrolimus was as follows: thiopurine 8, infliximab 4, golimumab 1, vedolizumab 4, ustekinumab 1, and guselkumab 2 as first-line agents... Tacrolimus is a key drug for refractory UC with a high remission rate. However, the selection of agents for maintenance therapy and cytomegalovirus activation remains problematic. Keywords: Ulcerative Colitis, Tacrolimus, Induction, Maintenance, Prognosis"

Retrospective data • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Movement Disorders • Nephrology • Renal Disease • Ulcerative Colitis

System-Level Redesign of an Allogeneic Hematopoietic Cell Transplantation Program Associated with High 1-Year Survival and Reduced Cost. (PubMed, Transplant Cell Ther) - "Implementation of a standardized, high-reliability allogeneic hematopoietic cell transplantation care model in a medium-sized program was associated with excellent 1-year overall survival, very low non-relapse mortality, manageable graft-versus-host disease rates, shorter hospitalization, and substantially lower pharmaceutical cost. These findings support the premise that disciplined operational standardization can complement contemporary biological advances in transplantation and may help programs improve both outcomes and value. Although limited by the single-center retrospective design and lack of randomized comparison, this experience suggests that center-level systems redesign is an important and actionable lever for improving allogeneic transplant care in the post-transplant cyclophosphamide era."

Journal • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Vasculopathic Cutaneous Ulceration as a Marker of Severe Systemic Disease in Anti-MDA5 Dermatomyositis (BAD 2026) - "Serial imaging demonstrated ongoing radiological progression despite escalating corticosteroid therapy and oral tacrolimus. Treatment with cyclophosphamide was planned...This case highlights the pivotal role of dermatologists in identifying high-risk cutaneous features in anti-MDA5 DM, interpreting their prognostic significance and markers of severe systemic disease, and influencing early multidisciplinary escalation of care in this life-threatening condition. British Society for the Study of Vulval Disease Oral presentations"

Cardiovascular • Dermatomyositis • Immunology • Infectious Disease • Inflammatory Arthritis • Interstitial Lung Disease • Myositis • Pneumonia • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Solid Tumor • IFIH1

Breaking the barrier: oral tacrolimus plus apremilast rescues acute generalized pustular psoriasis with severe comorbidities-a case report. (PubMed, Front Immunol) - "This case provides a valuable reference for optimizing treatment regimens and investigating mechanisms in refractory GPP. Further studies are required to enhance therapeutic efficacy and minimize adverse effects."

Journal • Cardiovascular • Chronic Kidney Disease • Dermatology • Diabetes • Dyslipidemia • Fibrosis • Hypertension • Immunology • Metabolic Disorders • Nephrology • Psoriasis • Pustular Psoriasis • Renal Disease • Type 2 Diabetes Mellitus

Fibrillary glomerulonephritis: 3 case report (ERA 2026) - "Oral prednisone tapered on a fixed schedule to 5 mg in the 3 rd month, Hydroxychloroquine and Rituximab 1000 mg x2 with maintenance treatment with mycophenolate mofetil 1g/12h and Rituximab 500 mg every 6 months...Treatment: methylprednisolone 500 mg x3 followed by cyclophosphamide every 2 weeks (1g).Prednisone tapered on a fixed schedule to 5 mg in the 3 rd month, RTX 1000 mg x2 and subsequent doses of 500 mg every 6 months (x4), oral tacrolimus and Hydroxychloroquine...Our renal outcomes so far are acceptable, even good, compared to other series despite the follow-up period is short. Image"

Case report • Clinical • Glomerulonephritis • Inflammatory Arthritis • Lupus Nephritis • Myositis • Nephrology

Efficacy, Safety, and Patient-Reported Convenience of Converting from Tacrolimus Capsule to Tablet Formulation (Tacrobell®) in Stable Kidney Transplant Recipients: A Single-Center, Non-Comparative, Phase IV Investigator-Initiated Pilot Study (ATC 2026) - "In subgroup analysis, trough levels were unchanged after generic-to-generic conversion (Tacrobell® capsule → Tacrobell® tablet; p = 0.174) but significantly decreased after original-to-generic switching (Prograf® capsule → Tacrobell® tablet; p = 0.003). This exploratory pilot study suggests that switching from tacrolimus capsules to tablets is feasible and well tolerated in stable kidney transplant recipients. Generic-to-generic conversion maintained stable tacrolimus exposure, whereas original-to-generic switching was associated with transient trough reductions. Larger studies integrating pharmacogenetic and formulation-specific factors are warranted to optimize individualized tacrolimus therapy."

Clinical • P4 data • Gastrointestinal Disorder • Transplantation