tolvaptan / Generic mfg. - LARVOL DELTA

The Relationship of Osmolality and Kidney Outcomes in Patients with Autosomal Dominant Polycystic Kidney Disease. (PubMed, Kidney360) - "Serum osmolality may be a possible surrogate marker for the clinical monitoring of ADPKD patients, especially when access to copeptin level is limited; and high serum osmolality conveys possible detrimental effect on the kidney outcomes."

Journal • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

Efficacy of Low-Dose Tolvaptan for Treatment of Profound Hyponatremia in Syndrome of Inappropriate Antidiuresis (SIAD): The EFFLUX-FLUID TRIAL. (PubMed, Kidney Med) - "This study evaluated whether low-dose tolvaptan is more effective than a combination of fluid restriction, furosemide, and sodium chloride tablets in patients with profound hyponatremia and clinical predictors of fluid restriction failure. Small sample size and single-center design. Low-dose tolvaptan effectively and rapidly increases [Na+] in SIAD patients with predictors of fluid restriction failure, with acceptable safety under close monitoring."

Journal • Cardiovascular • Heart Failure

Nonmyeloablative Allogeneic Stem Cell Transplantation With Postcyclophosphamide in a Case of Acute Lymphoblastic Leukemia Complicated by Ventricular Septal Defect. (PubMed, Transplant Proc) - "In this case of ALL with VSD, the VSD hole diameter continued to enlarge during chemotherapy; however, after pre-transplant conditioning with PTCy, the diameter began to decrease around one year post-transplant, though it did not return to its original size. While careful monitoring is needed for right heart failure due to VSD enlargement, pre-transplant conditioning with PTCy was considered a feasible option for hematologic malignancies complicated by VSD."

Journal • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Cardiovascular • Congestive Heart Failure • Graft versus Host Disease • Heart Failure • Hematological Disorders • Hematological Malignancies • Hepatology • Hypertension • Immunology • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Transplantation • CD34 • MME

Prognostic Value of an Early Response to Tolvaptan and Its Clinical Implications in Patients With Cirrhosis and Hepatic Edema: A Nationwide Multicenter Cohort Study. (PubMed, Hepatol Res) - "An early response to tolvaptan, which is more likely to occur in patients without elevated BUN concentrations or hyponatremia, is independently associated with improved long-term survival in patients with cirrhosis and hepatic edema. Our findings indicate the importance of initiating tolvaptan treatment before renal impairment or hyponatremia develops."

Clinical • Journal • Cardiovascular • Fibrosis • Heart Failure • Hepatocellular Cancer • Immunology • Oncology • Renal Disease • Solid Tumor

Hyponatraemia in heart failure: a mechanistic approach to contemporary management. (PubMed, Heart Fail Rev) - "For acute severe presentations, we detail hypertonic saline protocols with strict correction limits and discuss proactive desmopressin strategies to prevent osmotic demyelination. Important knowledge gaps persist, including optimal diagnostic algorithms in diuretic-exposed patients, patient-centred outcome data for sodium-correcting therapies, and validation of safe-correction protocols. Overall, this review equips clinicians to integrate mechanistic understanding with evidence-based practice whilst identifying priorities for future investigation."

Journal • Review • Cardiovascular • Congestive Heart Failure • Heart Failure

Pathogenic Pathways and Therapeutic Strategies in Autosomal Dominant Polycystic Kidney Disease (ADPKD). (PubMed, J Cell Signal) - "The vasopressin V2 receptor antagonists tolvaptan remains the only approved therapy, but new approaches are under investigation. These include inhibitors of mTORC1, Src, and RTKs, agents that block chloride secretion, small molecules and microRNAs that restore or enhance polycystin expression, and emerging cyst-directed cytotoxic therapies. By targeting aberrant epithelial responses to disrupted polycystin function, therapeutic intervention can be developed to halt cyst initiation, expansion, and progression to renal failure."

Journal • Autosomal Dominant Polycystic Kidney Disease • Chronic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease • ANO1 • PKD1 • PRKD1

Trajectories of Kidney Function in Autosomal Dominant Polycystic Kidney Disease Patients Treated with Tolvaptan. (PubMed, Medicina (Kaunas)) - "Our findings underscore the need to re-evaluate the current inclusion criteria for tolvaptan, particularly in real-world settings where patient variability is broader than in controlled clinical trials. Tailoring treatment qualification to include more practical and region-specific factors may enhance therapeutic outcomes."

Clinical • Journal • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

SerendipityPB1: Probenecid (PB) to Treat Hereditary Nephrogenic Diabetes Insipidus (NDI), ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration (clinicaltrials.gov) - P2 | N=36 | Completed | Sponsor: Mayo Clinic | Recruiting ➔ Completed

Trial completion • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Metabolic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

Tolvaptan: a potential rescue therapy for SIADH with refractory hyponatremia associated with acute intermittent porphyria. (PubMed, J Pediatr Endocrinol Metab) - No abstract available

Journal • Cardiovascular • Genetic Disorders • Heart Failure • Hematological Disorders • Metabolic Disorders

A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal Recessive Polycystic Kidney Disease (ARPKD) (clinicaltrials.gov) - P3 | N=20 | Recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Trial completion date: Feb 2028 ➔ Aug 2028 | Trial primary completion date: Feb 2028 ➔ Jul 2028

Trial completion date • Trial primary completion date • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

Eight Years of Canadian Real-World Assessment of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease: The C-MAJOR Registry. (PubMed, Can J Kidney Health Dis) - P | "This first report of 8-year follow-up data from the C-MAJOR registry confirms that most people with ADPKD treated with tolvaptan in Canada are in early CKD category of disease and at risk of rapid progression, with minimally impacted HRQoL at baseline. NCT02925221."

Clinical • Journal • Real-world evidence • Autosomal Dominant Polycystic Kidney Disease • Cardiovascular • Chronic Kidney Disease • Fatigue • Genetic Disorders • Hypertension • Nephrology • Pain • Polycystic Kidney Disease • Renal Disease

Desmopressin Induces Mitochondrial Fragmentation and Dysfunction in Human U87 MG Glioma Cells via CaMKII-Drp1 Signaling Pathway. (PubMed, Drug Dev Res) - "The AVPR2 antagonist tolvaptan blocked dDAVP effects, confirming receptor specificity. These findings reveal that dDAVP disrupts mitochondrial homeostasis in glioma cells through AVPR2-mediated CaMKII-dependent regulation of Drp1 activity, leading to mitochondrial dysfunction and cell damage. The study provides new insights into the molecular mechanisms underlying dDAVP's effects on glioma cells and suggests potential therapeutic applications targeting the CaMKII-Drp1 axis in glioma treatment."

Journal • Brain Cancer • Glioma • Metabolic Disorders • Oncology • Solid Tumor

A highly sensitive LC-MS/MS method for quantification of AB-38b in rat plasma, liver and kidney tissues: application to a pharmacokinetic study. (PubMed, Anal Methods) - "Sample preparation involved protein precipitation using methanol, with tolvaptan employed as the internal standard (IS)...The liver tissue contained high levels of AB-38b, with no evidence of tissue accumulation observed. These findings offer a reference for further research into the pharmacological mechanisms and potential therapeutic applications of AB-38b in metabolically related diseases, especially DKD."

Journal • PK/PD data • Preclinical • Diabetic Nephropathy • Nephrology • Renal Disease

Relcovaptan: a promising therapeutic agent in traumatic spinal cord injury that acts by modulating newly identified transcriptional regulators of aquaporins compared to tolvaptan. (PubMed, Turk J Med Sci) - "These include not only the positive effect on edema, which is achieved by suppression of Aqp1, Aqp4, and Aqp11 expression, but also immunoregulation, neuroprotection, neuroregeneration, and osmoregulation via activator protein-1 and galanin. Our study suggests that clinical application of relcovaptan may be a promising treatment option for improving tSCI."

Journal • CNS Disorders • Inflammation • Orthopedics • AQP1 • GAL

C-MAJOR: Canadian Medical Assessment of JINARC™ Outcomes Registry (clinicaltrials.gov) - P=N/A | N=530 | Completed | Sponsor: Otsuka Canada Pharmaceutical Inc. | Active, not recruiting ➔ Completed

Trial completion • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

Multi-Target Effects of Novel Synthetic Indanedione-Based Spirotransdicalinol Compound 4l in Autosomal Dominant Polycystic Kidney Disease. (PubMed, FASEB J) - "Tolvaptan is the only FDA-approved drug to treat ADPKD, which has significant side effects, prompting the need for safer novel treatments...4l's efficiency across 2D, 3D, and iPSC-derived models highlights its therapeutic potential. This study also recognizes mitophagy and necroptosis as novel targets in ADPKD and corroborates iPSC-derived renal cells as a powerful platform for drug screening."

Journal • Autosomal Dominant Polycystic Kidney Disease • Fibrosis • Genetic Disorders • Immunology • Nephrology • Oncology • Polycystic Kidney Disease • Renal Disease • Solid Tumor • AQP1 • CDKN1A • GATA3 • RB1 • RIPK1 • TGFB2

Early AI-driven repurposing study of existing drugs towards the vasopressin V2 receptor. (PubMed, Comput Biol Med) - "Five drugs were shortlisted as promising candidates for V2R: cabergoline, clopidogrel, cloxacillin, perphenazine, and zafirlukast...Interestingly, zafirlukast, at single-digit nanomolar concentration significantly reduced the DDAVP-dependent cAMP production and water reabsorption, with effects comparable to tolvaptan, a well-known selective V2R antagonist...Induced-fit docking simulations demonstrated that zafirlukast engages V2R by adopting a binding conformation closely resembling that of X-ray solved vasopressin. Taken together, our results support the repurposing of zafirlukast as a promising V2R antagonist candidate."

Journal • Oncology • CD4

A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | N=20 ➔ 0 | Trial completion date: Apr 2029 ➔ Dec 2025 | Recruiting ➔ Withdrawn | Trial primary completion date: Apr 2029 ➔ Dec 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

Stability of Medications Administered via Enteral Feeding Tubes: A Systematic Review. (PubMed, Clin Transl Sci) - "Approximately 20.8% of the studies found reduced stability/bioavailability for certain medications, such as warfarin and tolvaptan, while 8.3% of the studies found enhanced absorption, as observed with clopidogrel. Although most medications remain stable, concerns regarding instability and quality persist. The findings of this review provide a foundation for developing evidence-based guidelines to optimize clinical practice and improve patient outcomes."

Journal • Review

C-MAJOR: Canadian Medical Assessment of JINARC™ Outcomes Registry (clinicaltrials.gov) - P=N/A | N=530 | Active, not recruiting | Sponsor: Otsuka Canada Pharmaceutical Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

Case Report: One case of pregnancy complicated by large cell neuroendocrine carcinoma of the cervix with syndrome of inappropriate secretion of antidiuretic hormone. (PubMed, Front Oncol) - "The hyponatremia was successfully corrected with the selective vasopressin V2 receptor antagonist tolvaptan...A review identified deficiencies in the management, including initial insufficient investigation into the cause of hyponatremia, aggressive fluid therapy exacerbating the condition, and delays in multidisciplinary collaboration and systemic therapy. This case underscores the critical importance of multidisciplinary collaboration and early, aggressive systemic treatment in managing such complex and rare malignancies."

Journal • Cardiovascular • Cervical Cancer • Endocrine Cancer • Gynaecologic Neuroendocrine Carcinoma • Heart Failure • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Evaluation of the Use of Tolvaptan at a Large Academic Health System (ASHP 2025) - No abstract available

Comparative effectiveness and safety of tolvaptan vs. 3% hypertonic saline (HTS) in asymptomatic euvolemic or hypervolemic hyponatremia: A cohort analysis (ASHP 2025) - No abstract available

Clinical • HEOR • Cardiovascular • Heart Failure

Incidence of Sodium Overcorrection with Acute Tolvaptan Use (ASHP 2025) - No abstract available

Soluble Cluster of Differentiation 14 as a Prognostic Marker in Decompensated Cirrhosis With Water Retention. (PubMed, Hepatol Res) - "sCD14 is a potential biomarker for predicting prognosis, diuretic response, and acute kidney injury development in patients with decompensated liver cirrhosis and water retention. Its predictive capacity surpasses that of other bacterial translocation markers and may be influenced by administering therapeutic interventions, including rifaximin."

Biomarker • Journal • Acute Kidney Injury • Fibrosis • Gastroenterology • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Nephrology • Oncology • Renal Disease • Solid Tumor • CD14 • CD163