Treats secondary hyperparathyroidism (HPT). Sold as Parsabiv. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Etelcalcetide (sold as Parsabiv), first approved Feb 7, 2017, with 0 new uses approved and 0 published complete response letters.
| Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian StudyHemodialysis · Istituto di Fisiologia Clinica CNR | — | Not yet recruiting | Apr 8, 2024 |
| A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving HemodialysisSecondary Hyperparathyroidism · Amgen | Phase 3 | Recruiting | May 31, 2019 |
| A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on HemodialysisSecondary Hyperparathyroidism, Chronic Kidney Disease · Amgen | Phase 3 | Recruiting | Aug 16, 2018 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Feb 7, 2017 | ParsabivNDA 208325 · New molecular entity | Kai Pharms Inc | 3 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
