calcifediol / Generic mfg. - LARVOL DELTA

Calcifediol Suppressed Placental Inflammation and Improved Pregnancy Outcomes by Targeting JAK/STAT Signaling Pathway in Preeclampsia. (PubMed, Am J Reprod Immunol) - "Calcifediol elicits significant therapeutic effects in L-NAME-induced PE rat models by ameliorating PE symptoms and pregnancy outcomes, attenuating inflammatory responses and alleviating histopathological damage."

Journal • Cardiovascular • Diabetes • Gestational Diabetes • Gynecology • Hypertension • Inflammation • Metabolic Disorders • Renal Disease • JAK1 • STAT1 • STAT3

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: OPKO Health, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Pediatrics • Renal Disease • Secondary Hyperparathyroidism • TAP1

A close look at the bone in secondary hyperparathyroidism corrected with calcifediol. (PubMed, J Nephrol) - No abstract available

Journal • Endocrine Disorders • Secondary Hyperparathyroidism

Transcriptomics-based identification of shared biomarkers across type 2 diabetes, mild cognitive impairment, and uric acid metabolism. (PubMed, Exp Biol Med (Maywood)) - "Several potential therapeutic drugs were predicted, including calcifediol (score = -99.93) and meclofenamic acid (score = -99.89). This study identified three candidate biomarkers co-dysregulated across T2DM and MCI transcriptomes and associated with uric acid metabolism. Given the exploratory sample sizes, these findings are considered hypothesis-generating and require validation in larger independent cohorts."

Biomarker • Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Diabetes • Immunology • Metabolic Disorders • Primary Immunodeficiency • Type 2 Diabetes Mellitus • ITGB3 • SELP

Extended-release calcifediol identifies a therapeutic vitamin D range in chronic kidney disease stages 3 and 4. (PubMed, Clin Kidney J) - "Elevation of 25D to 84 ng/ml (range: 66.9-102.6 ng/ml) during ERC treatment was associated with a 30% iPTH reduction in participants with SHPT, CKD stage 3-4, and VDI. This range was unassociated with adverse changes in mineral metabolism."

Clinical • Journal • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism • FGF23

Modeling single nucleus microglia across species identifies immune pathways and therapeutic candidates in Alzheimer's disease. (PubMed, NPJ Syst Biol Appl) - "Additionally, we identified gene signatures from FDA-approved drugs that correlated with significant mouse component loadings, including valproic-acid and calcifediol. This computational framework may support the discovery of cross-species disease similarities, including the identification of candidate pharmacological solutions that may translate across species."

Journal • Alzheimer's Disease • CNS Disorders

Exposure–Response Analysis of Extended-Release Calcifediol Identifies a Clinically Relevant Serum 25-Hydroxyvitamin D Range in Chronic Kidney Disease (ERA 2026) - "The identified ER 30 range was substantially higher than conventional sufficiency thresholds of 20 or 30 ng/mL. Serum 25D concentrations within this range were not associated with adverse changes in mineral metabolism."

Clinical • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism • FGF23

Persistent Higher Serum Phosphorus in Hemodialysis Despite Dialysis and Greater Phosphate Binder Use: A Multicenter Study (ERA 2026) - "These findings highlight the persistent challenge of phosphorus control in dialysis patients and underscore the need for optimized, individualized strategies for managing mineral metabolism across advanced stages of chronic kidney disease. Table Variables CKD (Non-Dialysis) (n=43) Dialysis (n=118) p-value Sex ♂ 20 ♀ 23 ♂ 78 ♀ 40 Age (years) 76 65 <0,05 Use of ESA (%) 25,5 94 <0,05 Phosphate binder use (%) 27,9 81,3 <0,05 Serum phosphorus (mg/dl) 4 4 4,5 4,5 <0,05 <0,05 PTH (pg/ml) 152 340,6 <0,05 Calcifediol (ng/ml) 15 13,9 0,41"

Clinical • Cardiovascular • Chronic Kidney Disease • Metabolic Disorders • Nephrology

Hepatitis B Vaccine in Hemodialysis: wich factors influence the immune response? Is Vitamin D one of them? Then-Year Experience at our Hospital (ERA 2026) - "Conclusion Adequate vitamin D levels (>20 ng/ml), achieved through regular monitoring and supplementation with calcifediol o.266 mg were crucial for maintaingan effective and durable immuneresponse to HBV vaccination in chronic hemodialysis patients Ensuring effective strategy to optimize vaccine efficacy in HD patients, a population with a high prevalence of vitamin D deficiency. Furter studies are warranted to explore the impact of optimal vitamin D status on immunity in chronic kidney disease and transplantation setting, as well as to explore vitamin D potential adjuvant role in other vaccinations including SARS-CoV-2 and influenza."

Clinical • Chronic Kidney Disease • Diabetic Nephropathy • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Metabolic Disorders • Nephrology • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

Real-world effectiveness and safety of extended-release calcifediol in non-dialysis CKD patients with secondary hyperparathyroidism: the PORTRAY study (ERA 2026) - P | "Conclusion The sustained control of SHPT over 18 months, without significant or concerning changes in serum calcium and phosphorus levels, supports the use of ERC as a long-term treatment strategy for patients with CKD stages 3 and 4 in the real-world setting, particularly those at risk of hypercalcaemia, distinct from traditional vitamin D analogues. Greater improvements may have been achievable if ERC had been more frequently up-titrated."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Secondary Hyperparathyroidism

Vitamin D supplementation for fall prevention in nursing homes: Fall study in elderly people in Andalucía, Spain. (PubMed, Rev Esp Geriatr Gerontol) - "Nursing home residents were undertreated with vitamin D, the dosage with the lowest association with falls was cholecalciferol weekly."

Journal • Alzheimer's Disease • Cognitive Disorders • Geriatric Disorders • Infectious Disease • Osteoporosis • Respiratory Diseases • Rheumatology

New insights into the management of secondary hyperparathyroidism in non-dialysis dependent chronic kidney disease: extended release calcifediol. (PubMed, J Nephrol) - "These insights address the clinical relevance and provide actionable guidance for achieving and maintaining adequate vitamin D levels through the administration of extended-release calcifediol. This review underscores the importance of structured monitoring, evidence-based therapy initiation, and individualized care to improve bone and mineral metabolism in NDD-CKD patients, contributing to better long-term outcomes in this population."

Journal • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Orthopedics • Renal Disease • Secondary Hyperparathyroidism

EXPRESS: Serum vitamin D metabolites do not differ between cats with chronic kidney disease and healthy cats. (PubMed, J Feline Med Surg) - "Vitamin D metabolites were not significantly different in cats with CKD which could have implications for recommendations regarding calcitriol supplementation."

Journal • Nephrology • Orthopedics • Renal Disease

Targeting dysregulated glycolysis in type 2 diabetic osteoporosis: Identification of a diagnostic gene signature and therapeutic validation of calcifediol. (PubMed, Life Sci) - "Our research identifies eight glycolysis-related genes as candidate diagnostic and therapeutic targets with biological and causal plausibility for T2DOP. Calcifediol demonstrates promise as a preclinical therapeutic candidate for T2DOP, with the potential to enable simultaneous management of diabetic hyperglycemia and osteoporosis, and its clinical value requires further verification in subsequent studies."

Gene Signature • Journal • Diabetes • Metabolic Disorders • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology • Type 2 Diabetes Mellitus • ACADSB • PDLIM7 • PDZK1

Extended-release calcifediol vs active vitamin D for secondary hyperparathyroidism in non-dialysis CKD: a synthetic control arm study (ERA 2026) - No abstract available

Chronic Kidney Disease • Endocrine Disorders • Secondary Hyperparathyroidism

Overdiagnosed and Oversupplemented: The Iatrogenic Rise of Vitamin D Toxicity. (PubMed, Eur J Endocrinol) - "Calcifediol was documented in 183/201 (91.0%) hypervitaminosis D patients with available supplementation data and in 12/14 (85.7%) hypercalcaemic cases, often in short-interval dosing regimens. Rapid test growth paralleled a rightward shift and expanding high-concentration tail, supporting evidence-based requesting, clearer intermittent-dosing and supplementation instructions, and selective serum calcium surveillance when 25(OH)D is greatly elevated."

Journal

Systemic versus local regulation of vitamin D. (PubMed, Curr Opin Nephrol Hypertens) - "Recent tissue-specific investigations of vitamin D metabolism identified several physiologically relevant and potentially targetable tissues beyond the kidney. These findings may provide the basis for novel treatments in kidney disease and other vitamin D-associated disorders with wider therapeutic windows than current approaches that act on the kidneys."

Journal • Chronic Kidney Disease • Endocrine Disorders • Gastrointestinal Disorder • Nephrology • Renal Disease • Secondary Hyperparathyroidism

MASH associated lipotoxicity perturbs the expression of hepatic vitamin D bioactivating gene CYP2R1 in humans and mice. (PubMed, Biochem Biophys Res Commun) - "Calcifediol significantly induced vitamin D receptor (VDR) expression in human hepatocytes and hepatic stellate cell lines, suggesting the role of intra-hepatic calcifediol in maintaining VDR signalling. These findings uncover lipotoxic repression of CYP2R1 as a previously unrecognized mechanism contributing to vitamin D deficiency and impaired hepatic VDR signalling in MASH, highlighting hepatic vitamin D bioactivation as a potential therapeutic target."

Journal • Preclinical • Fibrosis • Hepatology • Immunology • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • CYP2R1 • VDR

Vitamin D in the prevention of left ventricular remodelling after an acute myocardial infarction: a randomized clinical trial. (PubMed, Sci Rep) - No abstract available

Clinical • Journal • Cardiovascular • Myocardial Infarction

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: OPKO Health, Inc.

New P2 trial • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Pediatrics • Renal Disease • Secondary Hyperparathyroidism • TAP1

SUSTAINED REDUCTION OF ELEVATED INTACT PARATHYROID HORMONE CONCENTRATIONS WITH EXTENDED-RELEASE CALCIFEDIOL SLOWS CHRONIC KIDNEY DISEASE PROGRESSION IN CHINESE SECONDARY HYPERPARATHYROIDISM PATIENTS:A POST-HOC ANALYSIS (ISN-WCN 2026) - "Serum calcium sightly increased from BL in the response group (CFB 0.2±0.2 mg/dL) but not in the non-response group (CFB 0.0±0.2 mg/dL). Duration of iPTH reduction had no impact on safety parameters.Conclusion Sustained mean reductions of ≥30% in elevated iPTH with ERC treatment were associated with slower eGFR decline in Chinese patients with SHPT and stage 3-4 CKD without raising safety concerns, a finding which was consistent with the results of the similar United States studies.I have potential conflict of interest to disclose.This study was sponsored by the Nicoya Therapeutics (Shanghai) Co.,Ltd.I did not use generative AI and AI-assisted technologies in the writing process."

Clinical • Retrospective data • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

Vitamin D Status in Young Medical Residents (clinicaltrials.gov) - P=N/A | N=30 | Completed | Sponsor: Maimónides Biomedical Research Institute of Córdoba

New trial

Vitamin D3 as an immunomodulatory agent: molecular mechanisms, clinical translation, and precision therapeutic strategies. (PubMed, Front Immunol) - "However, the immunomodulatory effects of Vitamin D3 exhibit significant inter-individual variability, with clinical efficacy highly dependent on patient-specific factors including serum 25-hydroxyvitamin D [25(OH)D, calcifediol] levels and VDR gene polymorphisms, driving a paradigm shift from empirical supplementation toward biomarker-guided precision medicine. Novel delivery systems-nanoemulsions, twin-screw extrusion technology, and liposomes-effectively overcome bioavailability and stability limitations of traditional preparations. This review systematically examines the immunomodulatory mechanisms of Vitamin D3, evaluates clinical translation evidence in psoriasis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), type 1 diabetes mellitus (T1DM), inflammatory bowel disease (IBD), and discusses precision medicine strategies and therapeutic potential."

Journal • Review • Dermatology • Diabetes • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lupus • Metabolic Disorders • Psoriasis • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • Type 1 Diabetes Mellitus • NLRP3 • VDR

Structure-Guided Co-Evolution of Fungal Unspecific Peroxygenase for Improved VD3 C25-Hydroxylation by Substrate-Binding Pocket Engineering. (PubMed, J Agric Food Chem) - "After two rounds of coevolution, a triple mutant (G195A/V244I/S272A, M3) was successfully obtained, demonstrating a 5.16-fold increase in C25-hydroxylation efficiency, with a increased the yield of 25(OH)VD3 from 45.8 to 354.40 mg/L. Our study elucidate how the geometry of the heme-VD3 complex effect catalytic efficiency during selective hydroxylation and guided a rational design for accelerating AaeUPO coevolution toward VD3 C25-hydroxylation."

Journal

How vitamine D deficiency influence on obesity and diabetes mellitus type 2 (ISGE 2026) - "If the expected results are not achieved, it is recommended to increase the dose of cholecalciferol or switch to calcifediol . In the case of concomitant liver or kidney disease, alfacalcidiol or calcitriol should be used . In summary, measuring vitamin D levels in obese or overweight individuals and initiating therapy if they are low is a valuable adjunct to the treatment of obesity and its consequences, such as prediabetes and type 2 diabetes."

Diabetes • Endocrine Disorders • Genetic Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus • PIAS4