fludrocortisone / Generic mfg. - LARVOL DELTA

A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001) (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Mar 2027 ➔ Mar 2026 | Trial primary completion date: Nov 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

PALETTE: Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial (clinicaltrials.gov) - P2 | N=2000 | Not yet recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Phase classification: P3 ➔ P2 | Trial completion date: Apr 2032 ➔ May 2031 | Trial primary completion date: May 2029 ➔ Jun 2028

Pan tumor • Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Septic Shock

Idiopathic Post-CAR-T Hypotension: Prevalence and Management with Midodrine and/or Fludrocortisone (TCT-ASTCT-CIBMTR 2026) - "Although poorly characterized, idiopathic hypotension is relatively uncommon following CAR- T therapy. AI workup may be prudent, and midodrine and/or fludrocortisone appear to be effective strategies. 1 ."

Endocrine Disorders • Hypertension • Hypotension • Nephrology • Renal Disease

Severe Cerebral Salt Wasting Complicating Arginine Vasopressin Deficiency After Traumatic Brain Injury. (PubMed, JCEM Case Rep) - "The CSW phase was characterized by severe hyponatremia with dramatic polyuria and natriuresis and required aggressive fluid replacement with hypertonic saline in addition to vasopressin infusion and fludrocortisone. This case highlights the dynamic nature of fluid balance disorders after brain injury, the importance of recognizing the distinctive patterns of plasma and urine parameters in each condition, and the aggressive management required to treat severe cerebral salt wasting."

Journal • Cardiovascular • CNS Disorders • Heart Failure • Otorhinolaryngology • Vascular Neurology

Diagnosis of primary aldosteronism: Confirmatory test. (PubMed, Vitam Horm) - "The most employed suppression tests are saline infusion (intravenous infusion or orally), fludrocortisone (FST) or a captopril challenge (CCT) test. Several studies have compared the performance of these tests, but there is wide variability between them, the choice of confirmatory test and in threshold values between referral centers, because of differences in laboratory methodologies and patients' characteristics."

Journal • Review • Cardiovascular • Endocrine Disorders • Hypertension

Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock (clinicaltrials.gov) - P4 | N=336 | Not yet recruiting | Sponsor: Northern Jiangsu People's Hospital

New P4 trial • Septic Shock

PHASE 3 MK-5684-004 STUDY OF CYP11A1 INHIBITOR OPEVESOSTAT VERSUS NEXT-GENERATION HORMONAL AGENT (NHA) SWITCH IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AFTER 1 PRIOR NHA (SUO 2024) - P3 | "Approximately 1500 patients (375 with, 1125 without AR-LBD mutations) will be randomly assigned 1:1 to receive opevesostat 5 mg PO BID + dexamethasone 1.5 mg and fludrocortisone 0.1 mg PO QD or abiraterone acetate 1000 mg PO QD (if prior enzalutamide/darolutamide/apalutamide) or enzalutamide 160 mg PO QD (if prior abiraterone). This abstract was previously presented at the 2024 ASCO Annual Meeting. ."

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Animal Models of Aortic Aneurysm and Dissection: A Comparative Guide for Mechanism, Therapeutic Testing, and Translational Readouts. (PubMed, Biomedicines) - "We critically compare commonly used abdominal aortic aneurysm (AAA) models (angiotensin II ± hyperlipidemia, elastase, calcium chloride, β-aminopropionitrile BAPN hybrids, and mineralocorticoid agonist/fludrocortisone models) with thoracic aortopathy and dissection models (BAPN alone or with AngII, genetic models including Marfan and smooth muscle contractile mutations, and AngII + TGF-β blockade)...A translational thread on platelet-intraluminal thrombus biology, including the emerging biomarker and therapeutic targets such as glycoprotein VI (GPVI), is integrated across models. We offer a decision grid and rigor checklist to harmonize model use, enhance reproducibility, and accelerate translation."

Journal • Preclinical • Review • Cardiovascular • Dyslipidemia • Thrombosis • ELANE • TGFB1

Adrenal Insufficiency due to Disseminated Cryptococcus in an Immunocompetent Individual. (PubMed, Case Rep Endocrinol) - "The patient was commenced on hydrocortisone and fludrocortisone, with improvement in symptoms. Treatment involved induction therapy with intravenous liposomal amphotericin-B 4 mg/kg daily and 5-flucytosine 25 mg/kg four times daily for 2 weeks, followed by consolidation therapy with fluconazole. This case highlights the importance of considering disseminated cryptococcosis in immunocompetent individuals presenting with adrenal insufficiency. Early diagnosis and appropriate antifungal therapy are crucial."

Journal • Endocrine Disorders • Fatigue • Infectious Disease • Nephrology • Renal Disease

Impact of COVID‑19 infection on subsequent prescriptions of autonomic dysfunction pharmacotherapy: a nationwide propensity‑score‑matched Cohort study in Japan. (PubMed, Ann Med) - "The primary composite outcome was the first outpatient prescription of midodrine, fludrocortisone, amezinium methylsulfate, and droxidopa. COVID-19 infection is significantly associated with increased initiation of pharmacotherapy for autonomic dysfunction, with sustained risk beyond one year. These findings highlight the to manage autonomic dysfunction among COVID-19 survivors and informing clinical care and public health planning."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypotension • Infectious Disease • Myocardial Infarction • Novel Coronavirus Disease

Efficacy and side effects of long-term treatment strategies of canine primary hypoadrenocorticism. (PubMed, Front Vet Sci) - "Based on the treatment applied, the following groups were assigned: prednisolone and desoxycorticosterone pivalate (DOCP, Zycortal®) (ZP, n = 167), prednisolone and desoxycorticosterone pivalate (DOCP, Percorten-V®) (PP, n = 39), prednisolone and fludrocortisone (FP, n = 23) and fludrocortisone (F, n = 15)...Good clinical disease control can be achieved with any of the above strategies. Applied DOCP dose were lower than previously reported and can be combined safely with low prednisolone dosages."

Adverse events • Journal • Cardiovascular • Heart Failure

A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009) (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology

The Effect of Fludrocortisone and Midodrine on Ambulatory Blood Pressure Biomarkers and Symptoms of Syncope. (PubMed, Blood Press) - "Symptoms of presyncope improved in 73.7% participants commencing/increasing fludrocortisone.Only 9/27 outcomes reached statistical significance in participants commencing/increasing midodrine: overall sBP increase commencing midodrine, overall sBP increase increasing midodrine (including subgroup ≥65 years), overall sBP increase commencing/increasing midodrine (including subgroup ≥65 years), minimum sBP increase commencing midodrine (including subgroup <65 years), decrease in sBP dips <100mmHg in subgroup aged ≥65 years increasing midodrine, and decrease in sBP dips <100mmHg in subgroup ≥65 years commencing/increasing midodrine. Symptoms of presyncope improved in 64.2% participants commencing/increasing midodrine.ConclusionThis study provides clinical data on the effectiveness of fludrocortisone and midodrine in patients with VVS/low BP phenotype and OH.Both fludrocortisone and midodrine significantly improved markers of future syncope risk, with fludrocortisone..."

Biomarker • Journal • Hypotension

Contemporary Global Management of 21-Hydroxylase Deficiency Congenital Adrenal Hyperplasia in Early Infancy: A Multi-national Registry Study. (PubMed, Eur J Endocrinol) - "Contemporary management of CAH in early infancy varies considerably. Hypertension and hyperkalaemia are frequently reported. Our data may help inform development of quality indicators for benchmarking CAH care in infancy."

Journal • Cardiovascular • Congenital Adrenal Hyperplasia • Endocrine Disorders • Hypertension • Hypoglycemia • Pediatrics

Tacrolimus-induced type 4 renal tubular acidosis after living donor kidney transplantation with a focus on early diagnosis and targeted treatment: a case report. (PubMed, Clin Transplant Res) - "The patient was treated with fludrocortisone (starting at 0.2 mg/day and tapered to 0.05 mg/day), a thiazide diuretic (12.5 mg twice daily), and reduction of tacrolimus dose with addition of sirolimus (2.5 mg/day). Electrolyte abnormalities resolved, and graft function remained stable without rejection. This case underscores the importance of recognizing tacrolimus-induced type 4 RTA early and using individualized treatment strategies to correct hyperkalemia and preserve allograft function."

Journal • Metabolic Disorders • Transplantation

Late-Onset NR0B1-Related Adrenal Hypoplasia Congenita Presenting With Primary Adrenal Insufficiency and Pubertal Delay. (PubMed, Cureus) - "On referral, he was receiving prednisolone and fludrocortisone and presented with short stature, absent puberty, and low adrenocorticotropic hormone (ACTH) levels. Switching to hydrocortisone improved biochemical parameters, but adrenal androgen precursors remained suppressed, and no pubertal development occurred by 15 years...Persistently low adrenal androgens despite elevated ACTH serve as a diagnostic clue. Early genetic testing allows accurate diagnosis, individualized therapy, and appropriate counseling of at-risk families."

Journal • Congenital Adrenal Hyperplasia • Endocrine Disorders • Fatigue • Immunology • Nephrology • Renal Disease • NR0B1

Genetic Insights and Lifelong Management of Aldosterone Synthase Deficiency: A Case of Hyperreninemic Hypoaldosteronism. (PubMed, Clin Case Rep) - "Routine newborn electrolyte screening after 5 days of life is vital for early detection and prevention of life-threatening crises. Genetic confirmation enables targeted fludrocortisone therapy, ensuring favorable growth and developmental outcomes."

Journal • Cachexia

Aldosterone Synthase Deficiency Type I in a Neonate: Diagnostic, Genetic, and Therapeutic Insights From a Novel CYP11B2 Variant. (PubMed, Cureus) - "Comprehensive workup, including genetic analysis, confirmed CMO I deficiency due to a novel homozygous CYP11B2 variant (NM_000498.3:c.239+1G>A), located at the donor splice site of intron 1. Early initiation of fludrocortisone and hydrocortisone led to favorable growth and development. This case underscores the importance of early recognition, genetic confirmation, and tailored therapy in managing rare neonatal electrolyte imbalances such as ASD type I."

Journal • Cardiovascular • Heart Failure

Management of LVAD in Cerebral Salt-Wasting Syndrome. (PubMed, Case Rep Crit Care) - "Treatment included normal saline drip for 1:1 volume replacement, daily fludrocortisone, low-dose desmopressin, and intermittent 3% hypertonic saline boluses. This is especially true in patients with LVADs, who are both preload-dependent and afterload-sensitive. Failure to rapidly treat CSWS can lead to respiratory arrest, brainstem herniation, and even death."

Journal • Cachexia • Cardiomyopathy • Cardiovascular • CNS Disorders • Congestive Heart Failure • Critical care • Heart Failure • Pain

A Phase II, Multicentre, 2-part, Study of the Safety, Tolerability, and Efficacy of Intravitreal Fludrocortisone Acetate in Subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration (ANZCTR) - P2 | N=9 | Active, not recruiting | Sponsor: EyeCo Pty Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Adrenal insufficiency in sickle cell disease: A Case series of a potentially underrecognized complication (ASH 2025) - "Therefore, fludrocortisone was initiated in this patient in addition to glucocorticoids...Severe disease requiring regular red cell exchanges, chronic opioid use, and iron overload, may represent potential risk factors for the development of AI, suggesting that patients with these complications may benefit from targeted or regular screening. These cases underscore the need for further investigation into the prevalence, risk factors, and approach to the evaluation of AI in SCD to better inform screening and diagnostic guidelines."

Clinical • Cardiovascular • Endocrine Disorders • Genetic Disorders • Hematological Disorders • Nephrology • Renal Disease • Sickle Cell Disease • Venous Thromboembolism

A rare presentation of cardiomyopathy associated with Addison's disease: a case report. (PubMed, Eur Heart J Case Rep) - "A short synacthen test confirmed the diagnosis, and he was started on dual therapy with hydrocortisone and fludrocortisone. It serves as a reminder of the complex physiological interactions that can cause cardiomyopathy, and further research is vital to improve understanding. Timely recognition and prompt treatment with steroids can lead to rapid reversal of cardiac function."

Journal • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Endocrine Disorders • Heart Failure • Nephrology • Rare Diseases • Renal Disease

Diagnostic pitfalls in aldosterone defects: a 9-year follow-up of early-onset pseudohypoaldosteronism type 2. (PubMed, J Pediatr Endocrinol Metab) - "Aldosterone pathway defects may be misdiagnosed during the initial clinical assessment. This underscores the importance of a comprehensive diagnostic approach incorporating biochemical profiling and genetic testing to ensure accurate identification. Next-generation sequencing has emerged as a valuable tool for establishing a definitive diagnosis, particularly in cases with aldosterone defects. Timely and accurate diagnosis of PHA2 is critical, as persistent metabolic acidosis and hypertension may lead to significant growth and developmental impairments in pediatric patients. Despite the potential severity of clinical manifestations associated with CUL3-related PHA2, it is noteworthy that treatment with thiazide diuretics alone can effectively restore electrolyte balance and support normal growth and development."

Journal • Cardiovascular • Heart Failure • Hypertension • Metabolic Disorders • Pediatrics • WNK1

Microvillus Inclusion Disease: Successful Treatment of Severe Hyponatremia With High-Dose Fludrocortisone via a Possible Gut-Mediated Mechanism. (PubMed, ACG Case Rep J) - "High-dose fludrocortisone (100 mcg bid; 28.4 mcg/kg/d) successfully restored serum sodium levels and reduced stool output, with normalization of renin and aldosterone, without adverse effects. This case demonstrates a potential therapeutic benefit of gastrointestinal mineralocorticoid receptor agonism in managing severe hyponatremia in patients with MVID during periods of acute decompensation."

Journal • Cardiovascular • Heart Failure

Progress in the pharmacological management of vasovagal syncope. (PubMed, Expert Rev Clin Pharmacol) - "Atomoxetine is under investigation. Some benefit from fludrocortisone, midodrine, or serotonin-specific reuptake inhibitors. Almost all patients eventually stop fainting, and invasive treatments should be used last and for the very few highly afflicted patients who do not improve with safer measures."

Journal • Review • Hypotension • Psychiatry