Global Peptide Index
Get weekly changes

calcimimetic peptide

Etelcalcetide updates

Answer

1 change for Etelcalcetide in the last 12 months. Latest: 2026-03-08.

DateTypeWhat changedSource
2026-03-08LabelFDA label revised: PARSABIV (NDA208325)Regulator FDA drug label register
2024-11-15TrialNew trial registered: MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney DiseaseTrial register ClinicalTrials.gov
2024-04-08TrialNew trial registered: Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian StudyTrial register ClinicalTrials.gov
2023-09-21ResultsResults posted: The Effect of Etelcalcetide on CKD-MBDTrial register ClinicalTrials.gov
2022-02-18Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2021-04-30ResultsResults posted: Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)Trial register ClinicalTrials.gov
2020-02-10ResultsResults posted: A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416Trial register ClinicalTrials.gov
2019-07-10ResultsResults posted: A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving HaemodialysisTrial register ClinicalTrials.gov
2019-05-31TrialNew trial registered: A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving HemodialysisTrial register ClinicalTrials.gov
2019-05-23TrialNew trial registered: The Effect of Etelcalcetide on CKD-MBDTrial register ClinicalTrials.gov
2019-01-07TrialNew trial registered: A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis PatientsTrial register ClinicalTrials.gov
2018-12-28Federal RegisterFederal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIVRegulator Federal Register
2018-08-16TrialNew trial registered: A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on HemodialysisTrial register ClinicalTrials.gov
2018-05-17TrialNew trial registered: Effect of Active Vitamin D and Etelcalcetide on Human Osteoclasts in Patients With Chronic Kidney DiseaseTrial register ClinicalTrials.gov
2018-01-02ResultsResults posted: Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary HyperparathyroidismTrial register ClinicalTrials.gov
2017-11-17ResultsResults posted: Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on HemodialysisTrial register ClinicalTrials.gov
2017-10-03TrialNew trial registered: Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)Trial register ClinicalTrials.gov
2017-09-14TrialNew trial registered: A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416Trial register ClinicalTrials.gov
2017-06-09TrialNew trial registered: Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis PatientsTrial register ClinicalTrials.gov
2017-04-14ResultsResults posted: Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving DialysisTrial register ClinicalTrials.gov
2017-04-14ResultsResults posted: Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male VolunteersTrial register ClinicalTrials.gov
2017-04-13ResultsResults posted: Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary HyperparathyroidismTrial register ClinicalTrials.gov
2017-04-13ResultsResults posted: Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary HyperparathyrTrial register ClinicalTrials.gov
2017-04-11ResultsResults posted: Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone DisorderTrial register ClinicalTrials.gov
2017-04-04ResultsResults posted: Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to EtelcalcetideTrial register ClinicalTrials.gov
2017-03-27ResultsResults posted: Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on HemodiaTrial register ClinicalTrials.gov
2017-03-27ResultsResults posted: Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on HTrial register ClinicalTrials.gov
2017-03-27ResultsResults posted: Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on HemodialysisTrial register ClinicalTrials.gov
2017-02-08ResultsResults posted: Head-to-Head Study of Etelcalcetide (AMG 416) and CinacalcetTrial register ClinicalTrials.gov
2016-07-14TrialNew trial registered: A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving HaemodialysisTrial register ClinicalTrials.gov
2014-04-02TrialNew trial registered: Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on HemodialysisTrial register ClinicalTrials.gov
2014-02-04TrialNew trial registered: Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving DialysisTrial register ClinicalTrials.gov
2013-08-30TrialNew trial registered: Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to EtelcalcTrial register ClinicalTrials.gov
2013-07-11TrialNew trial registered: Head-to-Head Study of Etelcalcetide (AMG 416) and CinacalcetTrial register ClinicalTrials.gov
2013-02-11TrialNew trial registered: Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKDTrial register ClinicalTrials.gov
2013-02-07TrialNew trial registered: Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on HTrial register ClinicalTrials.gov
2013-02-07TrialNew trial registered: Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on HemodialyTrial register ClinicalTrials.gov
2012-04-12TrialNew trial registered: Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary HyperpaTrial register ClinicalTrials.gov
2011-08-11TrialNew trial registered: Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone DisorderTrial register ClinicalTrials.gov
2010-12-06TrialNew trial registered: Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary HyperparathyroidismTrial register ClinicalTrials.gov
2010-06-02TrialNew trial registered: Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary HyperparathyroidismTrial register ClinicalTrials.gov
2010-06-02TrialNew trial registered: Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male VolunteersTrial register ClinicalTrials.gov

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

WEEKLY

Register Watch, weekly

New trials, approvals and enforcement actions. One email a week.