Parsabiv (etelcalcetide) / Amgen - LARVOL DELTA

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: Amgen | Trial completion date: Jun 2025 ➔ Jun 2027 | Trial primary completion date: Jun 2025 ➔ Jun 2027

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

Pre-emptive Parathyroidectomy and Hungry Bone Syndrome in Renal Transplant Candidates: A Management Conundrum (ENDO 2025) - "Medications including intravenous calcimimetics like etelcalcetide are used to lower PTH... This case of profound, persistent hypocalcemia highlights the difficulty in managing ESRD with SHPTH. Currently there are no standardized tools to predict the risk of severe HBS with PTX before renal transplant versus severe hypercalcemia without PTX after renal transplant. Optimal calcium and vitamin D levels prior to PTX are not well-established."

Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Metabolic Disorders • Nephrology • Osteoporosis • Secondary Hyperparathyroidism • Transplantation

Real-world safety profile of etelcalcetide in dialysis-related secondary hyperparathyroidism: a pharmacovigilance analysis of FAERS data. (PubMed, Ren Fail) - "Close monitoring in both early and long-term phases is essential for optimizing safety management. These findings provide valuable real-world evidence, underscoring the necessity of further research to refine clinical safety strategies."

Adverse events • Journal • Real-world evidence • Cardiovascular • Cerebral Hemorrhage • Chronic Kidney Disease • Congestive Heart Failure • Endocrine Disorders • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Infectious Disease • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases • Secondary Hyperparathyroidism • Septic Shock

Ca-sensing receptor agonists can improve taste sensitivity in hemodialysis patients. (ERA 2025) - "1) A comparison of taste thresholds was conducted between 12 hemodialysis patients with 2HPT (2HPT-HD) at our hospital prior to starting treatment with etelcalcetide, and 8 healthy controls (HC); 2) In the 2HPT-HD patients, taste thresholds were compared before and 3 months after starting etelcalcetide treatment... CaSR agonists may improve taste sensitivity in hemodialysis patients. Furthermore, many dialysis patients have potentially reduced taste sensitivity, which should be considered in dietary counseling."

Clinical • Diabetes • Diabetic Nephropathy • Endocrine Disorders • Metabolic Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism • CASR

Comparative effectiveness of etelcalcetide versus cinacalcet for the treatment of secondary hyperparathyroidism in patients in haemodialysis: a population-based study in Lazio, Italy (ERA 2025) - "The present study shows improvements in SHP control in both treatment groups with negligible differences between the two. Along with previous findings of a mortality reduction in patients treated with etelcalcetide with respect to cinacalcet, with a borderline statistical significance, this study confirms the efficacy and safety of etelcalcetide in SHP treatment in patients in haemodialysis."

Clinical • HEOR • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Secondary Hyperparathyroidism

Transfer of patients from cinacalcet to etelcalcetide: a retrospective cohort study in real world practice (ERA 2025) - "Etelcalcetide treatment resulted in a decrease in PTH levels in most hemodialysis patients. No new side effects or drug intolerance were observed when transferring patients from cinacalcet to etelcalcetide. In patients with moderate SHPT (PTH 600-1000 pg/mL), it is possible to achieve the target PTH in most cases, but in those with higher baseline PTH levels, the outcome was worse."

Real-world • Real-world evidence • Retrospective data • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Orthopedics • Renal Disease • Secondary Hyperparathyroidism

How novel drugs changed clinical practice in hemodialysis patients? (ERA 2025) - "Etelcalcetide is the first injectable calcimimetic drug with comparable efficacy to cinacalcet without the inevitable adherence limitations given by oral formulation. Ferric carboxymaltose demonstrated great efficacy in maintaining target haemoglobin levels in patients with clinically significant iron deficiency unresponsive to oral supplements significantly reducing the frequency of erythropoietin administration without the necessity of increasing medium dosage compared to other patients without any recorded side effect. Etelcalcetide demonstrated great efficacy in maintaining target PTH levels with limited drug dosage and minimal necessity of dosage adjustment. Hypocalcaemia was rare and never clinically significant."

Clinical • Anemia • Hematological Disorders • Orthopedics • Renal Disease

Indirect evaluation of bone metabolism in dialysis: do we all have the same bones? (ERA 2025) - "We analyzed demographic data (Date of birth, gender, blood type), comorbidities (Diabetes, hypertension), dialysis data (type of dialysis technique, dialytic age), blood tests (calcium, phosphate, Parathormone, Vitamin D), therapies (magnesium aluminate, calcium carbonate, sevelamer, sucroferric oxyhydroxide, lantanium carbonate, cholecalciferol, calcitriol, paracalcitol, cinacalcet, etelcalcetide) and fractures. In our analysis, we did not find any differences among the treatments for CKD-MBD to which the patients were subjected during the observed period. Our data suggest that, although preclinical studies and early stages of CKD showed that ADPKD patients exhibit distinct bone mineral disorders, no differences in treatment are observed in dialysis patients. Our data even confirm that there is no difference in fracture risk among hemodialysis patients."

Autosomal Dominant Polycystic Kidney Disease • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Genetic Disorders • Hypertension • Metabolic Disorders • Musculoskeletal Diseases • Nephrology • Orthopedics • Polycystic Kidney Disease • Renal Disease

Combination Treatment With Intravenous and Oral Calcimimetics for Secondary Hyperparathyroidism in Hemodialysis Patients Who Decline Parathyroidectomy. (PubMed, Cureus) - "The combination of intravenous and oral calcimimetics is an effective therapeutic option for managing SHPT in patients on HD who refuse PTX. While promising, the long-term safety and potential risks of this approach, including the occurrence of malignancies, warrant further investigation in larger prospective studies."

Journal • Cardiovascular • Endocrine Disorders • Gastrointestinal Disorder • Kidney Cancer • Oncology • Renal Cell Carcinoma • Secondary Hyperparathyroidism • Solid Tumor

Regulatory effects of Poria cocos polysaccharides on gut microbiota and metabolites: evaluation of prebiotic potential. (PubMed, NPJ Sci Food) - "Furthermore, P. cocos polysaccharides enhanced the production of key microbial metabolites, significantly upregulating compounds such as L-cystine and etelcalcetide. Collectively, these findings underscore the beneficial role of P. cocos polysaccharides in promoting intestinal health and highlight their potential as prebiotics in the functional food industry."

Journal

The calcium-sensing receptor: a comprehensive review on its role in calcium homeostasis and therapeutic implications. (PubMed, Am J Transl Res) - "Current pharmacological agents, including calcimimetics such as cinacalcet and etelcalcetide, have proven effective in managing secondary hyperparathyroidism (SHPT); however, they are associated with side effects such as hypocalcemia. Emerging investigational drugs, including palopegteriparatide and other small molecules, show promise in addressing various calcium-related conditions. Despite challenges that have led to the discontinuation of some drug developments, ongoing research is focused on refining CaSR-targeted therapies to improve efficacy, reduce adverse effects, and enhance patient outcomes."

Journal • Review • Endocrine Disorders • Hypoparathyroidism • Secondary Hyperparathyroidism

Adverse events reporting of Etelcalcetide: a real-word analysis from FAERS database. (PubMed, J Pharm Policy Pract) - "This work successfully identified previously unidentified and novel signals linked to AEs associated with the administration of Etelcalcetide, offering crucial insights into the intricate relationship between AEs and Etelcalcetide use. In the context of Etelcalcetide therapy, the study's findings highlight the vital significance of diligent surveillance and ongoing monitoring for the prompt detection and efficient management of AEs and to enhance overall patient safety and well-being."

Adverse events • Journal • Cardiovascular • Endocrine Disorders • Infectious Disease • Renal Disease • Secondary Hyperparathyroidism

MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=112 | Recruiting | Sponsor: Shaanxi Micot Technology Limited Company | Trial completion date: Sep 2025 ➔ Mar 2026

Trial completion date • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

Etelcalcetide: What we know eight years since its approval. (PubMed, Nefrologia (Engl Ed)) - "Etelcalcetide is effective in controlling SHPT. Promising data is available for some bone and surrogate cardiovascular endpoints, suggesting a possible beneficial effect. There is a lack of studies specifically designed to evaluate its role in reducing fractures, CV and all-cause mortality."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Musculoskeletal Diseases • Nephrology • Orthopedics • Renal Disease • Secondary Hyperparathyroidism • FGF23

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS (PRNewswire) - "Our established products, which consist of EPOGEN (epoetin alfa), Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide) and Neulasta (pegfilgrastim), generated $500 million of sales in the fourth quarter. Sales decreased 29% year-over-year for the fourth quarter, driven by volume declines, unfavorable changes to estimated sales deductions and lower net selling price. Sales decreased 19% for the full year, driven by volume declines, lower net selling price and unfavorable changes to estimated sales deductions."

Sales • Chronic Kidney Disease • Hematological Disorders • Neutropenia

Renal phosphate excretion is differentially regulated depending on preserved or reduced kidney function (IPNA 2025) - "In the long-term experiment, one HPD group was additionally treated after four months with a calcimimetic (etelcalcetide) in order to lower FGF23 and PTH. Phosphate-mediated PiT-2/ERK1/2 activation could be blocked by simultaneous treatment with foscarnet. Conclusions Our data suggest that in mice with preserved kidney function, activation of ERK1/2 by FGF23 and PTH mediates phosphate excretion, but in mice with impaired kidney function, high extracellular phosphate concentrations lead to internalization of NPT2a via direct activation of the PiT-2/ERK1/2 signaling pathway, resulting in increased renal phosphate excretion, independent of FGF23 or PTH."

Cardiovascular • Chronic Kidney Disease • Nephrology • Renal Disease • FGF23 • FGFR1

Calcimimetics ameliorate impaired cardiac function and contractility in chronic phosphate load through activation of the CaSR/cAMP signaling pathway (IPNA 2025) - "In addition, one HPD group was treated with etelcalcetide (Etl) after four months for additionally two months via osmotic mini pumps...Conclusions In addition to the well-established benefit of an FGF23 reduction on cardiac health, Etl directly leads to an improvement in the pathological cardiac phenotype induced by Pi. This positiv effect can be attributed, at least in part, to direct activation of the CaSR/cAMP signaling pathway, resulting in improved cardiomyocyte contractility."

Cardiovascular • Chronic Kidney Disease • Fibrosis • Immunology • Nephrology • FGF23

Practice patterns on the management of secondary hyperparathyroidism in the United States: Results from a modified Delphi panel. (PubMed, PLoS One) - "Expert consensus was reached on SHPT management, further defining therapeutic strategies and medication use and emphasizing need for treatment early. Despite evidence-based treatment preferences supported by clinical experience, factors other than scientific evidence influence decision making, particularly with medications."

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

A CLINICAL AUDIT COMPARING LOW AND STANDARD DOSES OF INTRAVENOUS ETELCALCETIDE IN HAEMODIALYSIS PATIENTS (ISN-WCN 2025) - "Conclusions The audit demonstrated that low and standard etelcalcetide doses had comparable effects on PTH levels in patients undergoing HD. Based on specific patient characteristics, such as dialysis vintage, baseline PTH and SAP levels, and clinical assessment, initiating doses lower than the recommended amount can be considered."

Clinical • Endocrine Disorders • Secondary Hyperparathyroidism

A Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis (clinicaltrials.gov) - P3 | N=56 | Recruiting | Sponsor: Amgen | Trial completion date: Jan 2026 ➔ Jan 2027 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Pediatrics • Renal Disease • Secondary Hyperparathyroidism

MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=112 | Recruiting | Sponsor: Shaanxi Micot Technology Limited Company | Not yet recruiting ➔ Recruiting

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

Real world evaluation of etelcalcetide in the treatment of secondary hyperparathyroidism in hemodialysis patients in Argentina. (PubMed, Ther Apher Dial) - "EC effectively lowered iPTH and P levels, with a sustained effect over 2 years."

HEOR • Journal • Real-world • Real-world evidence • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=112 | Not yet recruiting | Sponsor: Shaanxi Micot Technology Limited Company

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

Involvement of Calcium (Ca)-Sensing Receptor in the Development of Interstitial Fibrosis (KIDNEY WEEK 2024) - "In this study, we administered etelcalcetide (ETL), a CaSR agonist, to a renal fibrosis model to analyze the relationship between CaSR and renal fibrosis. We created a renal fibrosis model using 8-week-old Sprague-Dawley rats with unilateral ureteral obstruction (UUO)... ETL partially restored reduced CaSR expression in the kidney, improved renal fibrosis, and inhibited the accumulation of extracellular matrix. The involvement of BMP-7 suggests that CaSR agonists could be a novel therapeutic approach for inhibiting renal fibrosis."

Fibrosis • Immunology • CASR

New calcimimetics for secondary hyperparathyroidism in CKD G5D: do they offer advantages? (PubMed, J Nephrol) - "To address the problem of oral compliance, Etelcalcetide, a small synthetic polycationic peptide IV calcimimetic was introduced in 2017...Several structural modifications were introduced in cinacalcet to produce a new compound called evocalcet...Finally, a novel non-peptidic injectable calcimimetic agent, upacicalcet, became available in Japan in 2021. This agent has greater clearance by hemodialysis and shows no effect on gastric emptying. More studies are needed comparing the old calcimimetics to the new ones to establish their future role in the treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) G5D."

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