Parsabiv (etelcalcetide) / Amgen - LARVOL DELTA

THE EFFECT OF ETELCALCETIDE ON UNCONTROLLED SECONDARY HYPERPARATHYROIDISM AMONG HEMODIALYSIS PATIENTS- SINGLE CENTRE EXPERIENCE. (ISN-WCN 2026) - "Many dialysis patients have uncontrolled hyperparathyroidism despite using Calcium supplements, vitamin D analogs & oral calcimimetics (Cinacalcet). Phosphorus level (mmol/L) during different study stages.Phosphorus level (mmol/l)StartAfter 6 monthsSep. 2025Phosphorus 3.0211Patient number463645Phosphorus 3.04.35%2.78%2.22%Conclusion 1) Etelcalcetide is a safe and well tolerated novel treatment for challenging secondary hyperparathyroidism cases among hemodialysis patients.2) Etelcalcetide is a very effective treatment for controlling iPTH.3) Secondary hyperparathyroidism control can be achieved with well balanced and patient specific treatment regimens including Etelcalcetide.4) Medication compliance and concordance can be improved significantly with IV Etelcalcetide treatment on dialysis for many patients."

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

REGRESSION OF UREMIC TUMORAL CALCINOSIS FOLLOWING ETELCALCETIDE THERAPY IN HEMODIALYSIS PATIENTS (ISN-WCN 2026) - "At that time, he was receiving cinacalcet hydrochloride and lanthanum carbonate.Results We considered his intact PTH level was potentially underestimated, because blood sampling had been performed several hours after cinacalcet administration. Etelcalcetide has been reported to produce more sustained reductions in serum calcium and PTH levels than cinacalcet in hemodialysis patients, and this pharmacological property may contribute to the dissolution of calcified deposits. Our experience suggests that intravenous etelcalcetide therapy could represent a valuable therapeutic option for uremic tumoral calcinosis in selected patients, potentially expanding current management strategies beyond conventional approaches focused solely on calcium-phosphate control."

Clinical • Endocrine Disorders • Metabolic Disorders • Musculoskeletal Diseases • Nephrology • Oncology • Orthopedics • Renal Disease

EFFICACY AND SAFETY OF MT1013 COMPARED TO ETELCALCETIDE IN PATIENTS WITH SECONDARY HYPERPARATHYROIDISM UNDERGOING MAINTENANCE DIALYSIS (ISN-WCN 2026) - P2 | "It was well tolerated in CKD-SHPT patients, with no severe TEAEs, drug-related SAEs, or new safety signals. A lower rate of symptomatic hypocalcemia in the MT1013 group was observed, compared to etelcalcetide group.Conclusion MT1013 outperforms etelcalcetide with higher on-target rates for iPTH, Ca, and P. Its dual-targeting mechanism provides holistic control of mineral metabolism and FGF-23, offering potential for improved patient prognosis.The study, MT1013 C03, had partial data submitted to the American Society of Nephrology (ASN) late-breaking session in September 2025"

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

LOWER INCIDENCE OF HYPOCALCEMIA IN HEMODIALYSIS PATIENTS RECEIVING EVOCALCET COMPARED WITH ETELCALCETIDE: A MULTICENTER COHORT STUDY (MBD-NEXT) (ISN-WCN 2026) - "TH has received personal fees from Kissei Pharmaceutical and KKC, and grants from KKC. The remaining author has nothing to disclose.I did not use generative AI and AI-assisted technologies in the writing process."

Clinical • Endocrine Disorders • Renal Disease

Evaluating calcimimetic use: An audit of two UK renal centres (UKKW 2026) - "Results Centre 1 - 69 patients (17% of HD population) were identified; 48/69 (70%) were prescribed Cinacalcet and 21/69 (30%) Etelcalcetide. Given the burden of symptoms, the costs, and the tablet burden associated with SHPT, ensuring effective prescribing is key. Findings highlight a need for prescribing protocols to guide management and improve the clinical safety and effectiveness of calcimimetics."

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

Preferred but Restricted: Impact of the End Stage Renal Disease Bundle on Dialysis Treatment (NKF-SCM 2026) - "One example of this phenomenon is in etelcalcetide patient share, which is expected to stabilize near 12% among calcimimetic-treated HD patients with no recovery anticipated, while cinacalcet continues to dominate calcimimetic use. CONCLUSION US-based nephrologists describe a pronounced gap between their preferred use of medications for their ESRD patients and what they can realistically deliver under the ESRD bundle, with administrative barriers driving use of various agents down despite interest in them. These findings indicate that the central challenge is not awareness or clinical interest, but bundle-driven restrictions and center-level protocols and highlight clear opportunities to refine access strategies to align with physicians’ clinical priorities."

Chronic Kidney Disease • Nephrology • Renal Disease

In Vitro Analysis of Effects of Upacicalcet, Cinacalcet, and Etelcalcetide on the Calcium Sensing Receptor (CaSR) (NKF-SCM 2026) - "The distinct in vitro activation profiles of upacicalcet, cinacalcet, and etelcalcetide may translate to differences in clinical outcomes, particularly regarding risk of hypocalcemia and potentially gastrointestinal adverse effects. Further clinical studies are warranted to confirm whether these in vitro differences in CaSR activation are associated with differentiated safety and efficacy profiles in hemodialysis patients with SHPT."

Preclinical • Endocrine Disorders • Renal Disease • Secondary Hyperparathyroidism

Switching patients from cinacalcet to etelcalcetide: evaluation of predictors of efficacy in a retrospective cohort study (PubMed, Probl Endokrinol (Mosk)) - "In moderate SHPT (PTH 600-1000 pg/ml) it is possible to achieve the target in most patients, but with higher level, the result worsened. The signs of parathyroid authonomy predicts the insufficient effect better than high baseline PTH level."

Journal • Retrospective data • Renal Disease • Secondary Hyperparathyroidism

The calcimimetic etelcalcetide attenuates pressure overload-induced cardiac hypertrophy in rats with and without chronic kidney disease. (PubMed, Biomed Pharmacother) - "ET effectively suppressed LVH in the LVH and CKD/LVH groups. These findings suggest that ET's cardioprotective effects are mediated via the modulation of the RAAS and cardiac FGF23 expression rather than solely through the correction of CKD-mineral bone disorder abnormalities."

Journal • Preclinical • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Orthopedics • Renal Disease • Secondary Hyperparathyroidism • FGF23

MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=115 | Completed | Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Oct 2025

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

Measurement of ionized calcium with a point-of-care ionometer during etelcalcetide therapy. (PubMed, Clin Nephrol) - "Our results highlight the value of direct iCa monitoring as a practical and sensitive tool for detecting hypocalcemia and guiding etelcalcetide therapy. Bedside measurement enabled timely dialysate calcium adjustments, preventing clinically significant hypocalcemia and treatment discontinuation. Point-of-care iCa monitoring offers a safer, more responsive strategy for optimizing calcium management in hemodialysis patients."

Journal • Observational data • Endocrine Disorders • Renal Disease

Long-Term Efficacy of Etelcalcetide in a Patient on Hemodialysis with Refractory Secondary Hyperparathyroidism: A 15-Month Follow-Up Case Report (KIDNEY WEEK 2025) - "Persistent SHPT (baseline iPTH 200–500 pg/mL) proved resistant to sequential therapies: paricalcitol (5 μg biweekly, halted for hypercalcemia and hyperphosphatemia) and cinacalcet (25–50 mg daily, discontinued for severe dyspepsia). Dynamic monitoring of calcium and iPTH is crucial for maintaining therapeutic stability. Changes in serum levels of parathyroid hormone (PTH), calcium (Ca), and phosphorus (P)"

Case report • Clinical • Dyspepsia • Endocrine Disorders • Metabolic Disorders • Nephrology • Secondary Hyperparathyroidism • Vasculitis

Parathyroidectomy in ESRD: The Challenge of Determining the Right Patient (KIDNEY WEEK 2025) - "One can argue that we traded the cinacalcet for the dependence on liquid calcium supplementation. One could also consider whether she would have tolerated etelcalcetide but the medication is also associated with gastrointestinal side effects. After her parathyroidectomy, the parathyroid hormone level is lower, but the patient continues to suffer from chronic gastroparesis and now chronic hypocalcemia and hypoparathyroidism. It could be helpful to have a specialist in bone health and ESRD, which may not be available in every facility, in guiding treatment plans."

Clinical • Chronic Kidney Disease • Endocrine Disorders • Gastrointestinal Disorder • Hypoparathyroidism • Nephrology • Renal Disease

Efficacy and Safety of MT1013 vs. Etelcalcetide for Secondary Hyperparathyroidism in Patients on Hemodialysis (KIDNEY WEEK 2025) - P2 | "It was well tolerated in CKD-SHPT patients, with no severe TEAEs, drug-related SAEs, or new safety signals. Conclusion MT1013 outperforms etelcalcetide with higher on-target rates for iPTH, Ca, and P. Its dual-targeting mechanism provides holistic control of mineral metabolism and FGF-23, offering potential for improved patient prognosis."

Clinical • Late-breaking abstract • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Secondary Hyperparathyroidism • FGF23

Etelcalcetide Use Rates Decrease and Parathyroidectomy Rates Increase Following the Incorporation of Calcimimetics into the ESKD Bundle (KIDNEY WEEK 2025) - "Calcimimetics, such as cinacalcet and etelcalcetide (ETEL), are used to manage SHPT and reduce the risk of PTX. After TDAPA, PTX rates rose from 2.9 to 4.8 and 4.6 to 6.5 per 1,000 pt-years in S/MDOs and Black pts, respectively. Conclusion These findings highlight the impact of reimbursement policy on clinical practice and pt outcomes, underlining the unintended consequences of reducing access to effective therapies, increasing health disparities, and potentially suppressing future therapeutic innovation."

Endocrine Disorders • Nephrology • Secondary Hyperparathyroidism

Effects of Switching from Etelcalcetide to Upacicalcet in Patients on Hemodialysis with Secondary Hyperparathyroidism (KIDNEY WEEK 2025) - "Serum levels of corrected calcium (Ca), phosphorus (P), intact parathyroid hormone (iPTH), and the dose of maxacalcitol were assessed at three and six months after switching to upacicalcet. Multiple regression analysis revealed that the change in iPTH was related to the change in P levels. Conclusion These findings suggested that upacicalcet may be a useful option for managing serum P levels in hemodialysis patients with SHPT."

Clinical • Endocrine Disorders • Renal Disease • Secondary Hyperparathyroidism

Reductions in Etelcalcetide Use After Withdrawal of the Transitional Drug Add-On Payment Adjustment (KIDNEY WEEK 2025) - "Conclusion Following TDAPA, etelcalcetide prescriptions declined, particularly among clinically and socially vulnerable subgroups. Monitoring of payment reforms should ensure that unintended consequences do not jeopardize equitable access to medications."

Endocrine Disorders • Secondary Hyperparathyroidism

Etelcalcetide for Secondary Hyperparathyroidism in Cinacalcet-Resistant Patients on Hemodialysis: A Real-World Multicenter Study (KIDNEY WEEK 2025) - "Conclusion Our real-world multicenter study showed that Etelcalcetide was effective and well tolerated in HD patients with sHPT who are resistant or intolerant to cinacalcet. It enabled most patients to achieve guideline-recommended targets in a relatively short timeframe."

Clinical • Real-world • Real-world evidence • Chronic Kidney Disease • Endocrine Disorders • Nephrology • 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 2027 ➔ Jan 2029 | Trial primary completion date: Jan 2027 ➔ Jan 2029

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

The effects of switching from etelcalcetide to upacicalcet in hemodialysis patients with secondary hyperparathyroidism. (PubMed, Clin Nephrol) - "These findings suggested that upacicalcet may be a useful option for managing serum P levels in hemodialysis patients with SHPT."

Journal • Endocrine Disorders • Renal Disease • Secondary Hyperparathyroidism

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