Parsabiv (etelcalcetide) / Amgen - LARVOL DELTA

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

Transfer of patients from cinacalcet to etelcalcetide: a retrospective cohort study in real world practice (ERA 2025) - No abstract available

Real-world • Real-world evidence • Retrospective data

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) - No abstract available

Clinical • HEOR • Endocrine Disorders • 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

Rationale and Protocol of the ETERNITY-ITA Study: Use of Etelcalcetide for Preserving Vitamin K-Dependent Protein Activity-An Italian Study. (PubMed, J Clin Med) - " This study will evaluate the real-world effect of Etelcalcetide on VKDP levels, such as BGP and MGP, at 3, 9, and 18 months from baseline. The resulting preservation of vascular and bone health will be assessed for the first time by examining aortic and iliac artery calcifications and vertebral fractures, respectively."

Journal • Chronic Kidney Disease • Endocrine Disorders • Musculoskeletal Diseases • Nephrology • Orthopedics • Secondary Hyperparathyroidism • MGP

Efficacy of Peridialytic Cinacalcet in Controlling Hyperparathyroidism in Non-observant Patients on Chronic Hemodialysis in Western French Guiana (KIDNEY WEEK 2024) - "G1: Patients on intravenous Etelcalcetide at the end of the dialysis session three times a week, G2: Patients on non-observing Cinacalcet that we put on Cinacalcet 3 times a week at the end of the dialysis session and 4 times at home and G3: Patients on Cinacalcet observing that we kept under a daily dose at home. Conclusion. The perdialytic administration of Cinacalcet seems to be an interesting alternative in the control of hyperparathyroidism in non-compliant chronic hemodialysis patients.."

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

Heterogenous Origins of Calcium Homeostasis Disorders Arising from Five Heterozygous Calcium-Sensing Receptor Variants. (PubMed, J Clin Endocrinol Metab) - "While the molecular phenotypes exhibited by the five CaSR variants concord with the clinical phenotypes in individuals harboring them, CASR variant-induced calcium homeostasis disorders clearly arise from diverse molecular origins, and the effectiveness of calcimimetics in these disorders could differ depending on the specific variants."

Journal • Endocrine Disorders • Metabolic Disorders • CASR

Incorporation of Calcimimetics into ESRD Bundle: Changes in Etelcalcetide Utilization and PTH Control Following End of TDAPA Designation. (PubMed, Clin J Am Soc Nephrol) - "Etelcalcetide use decreased substantially after TDAPA ended in January 2021, with most patients switching to cinacalcet. The subsequent increase in PTH levels was swift and sustained, and especially pronounced among Black patients, raising concerns about disparities and potential downstream impact on clinical outcomes. Despite the spirit of the policy change, the flat per-treatment increased payment may have inadvertently created a financial incentive to restrict patient access to a more effective therapy, and potentially stifle drug innovation."

Journal • Chronic Kidney Disease

Etelcalcetide ameliorates bone loss in chronic kidney disease-mineral and bone disorder by activation of IRF7 and necroptosis pathways. (PubMed, Int J Biol Macromol) - "Etelcalcetide likely enhances bone parameters in CKD-MBD mice by regulating IRF7 pathways and inhibiting OC differentiation. It also improves bone health and promotes RIP-mediated necroptosis and apoptosis pathways within OCs."

Journal • Chronic Kidney Disease • Inflammation • Nephrology • Orthopedics • Osteoporosis • Renal Disease • CASP9 • IFNB1 • IRF7

Calcimimetics improve impaired cardiac function and cardiomyocyte contractility in mice with kidney failure via activation of the CaSR/cAMP signaling pathway (ESPN 2024) - " Wild-type mice were fed a high phosphate diet (HPD) ± etelcalcetide (Etl) or a normal phosphate diet (NPD), cardiac function was assessed by echocardiography and Millar catheterization, and cardiac tissue was harvested for histology and RNAseq analysis... In addition to the positive secondary effects of FGF23 reduction on the heart, Etl effectively improves the Pi-induced pathological cardiac phenotype despite hyperphosphatemia, at least in part due to direct activation of the CaSR/cAMP signaling pathway, resulting in improved cardiomyocyte contractility."

Preclinical • Cardiovascular • Fibrosis • Immunology • Metabolic Disorders • Nephrology • FGF23

Etelcalcetide use During Maintenance Hemodialysis and Incidence of Parathyroidectomy After Kidney Transplantation. (PubMed, Kidney Int Rep) - "Long-term graft function, graft loss, and mortality were similar. Etelcalcetide use during maintenance HD is associated with an increased incidence of early parathyroidectomy after transplantation compared to cinacalcet or no calcimimetic."

Journal • Endocrine Disorders • Nephrology • Renal Disease • Transplantation

Effects of active vitamin D analogs and calcimimetic agents on PTH and bone mineral biomarkers in hemodialysis patients with SHPT: a network meta-analysis. (PubMed, Eur J Clin Pharmacol) - "The same kinds of agents perform similar efficacy on the level of PTH, serum calcium, phosphorus, and calcium-phosphorus product. Paricalcitol did not lead to more hypercalcemia than calcitriol. The calcium decrease induced by cinacalcet was not settled even by associating it with active vitamin D analogs. Cinacalcet and evocalcet were superior to calcitriol and paricacitol in reducing calcium-phosphorus product. Calcimimetics induced more gastrointestinal disorders than active vitamin D analogs, especially cinacalcet."

Biomarker • Clinical • Journal • Retrospective data • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Renal Disease • Secondary Hyperparathyroidism