Drugs / Etelcalcetide
Etelcalcetide
also known as
AMG 416 · Etelcalcetida · ETELCALCETIDE HYDROCHLORIDE · KAI-4169 · KAI-4169 HCl · KAI-4169 HYDROCHLORIDE · ONO-5163 · Parsabiv · +4 more
Other / unclassified targets CASR via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PARSABIV | — | 2017-02-07 | fda.gov ↗ |
| Approved | EU (EMA) | Parsabiv | — | 2016-11-11 | europa.eu ↗ |
Trials 19 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT03283098 | Mar 2018 → Feb 2019 | secondary hyperparathyroidism of renal origin | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02833857 | Mar 2017 → Oct 2018 | secondary hyperparathyroidism of renal origin | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02054572 | Feb → Apr 2014 | secondary hyperparathyroidism of renal origin | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01134562 | Sep 2010 → Apr 2011 | secondary hyperparathyroidism of renal origin | KAI Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01134549 | Jun → Jul 2010 | secondary hyperparathyroidism | KAI Pharmaceuticals | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT03795558 | May 2019 → Dec 2021 | end stage renal failure | Prim. Priv. Doz. Dr. Daniel Cejka | Completed | No outcome recorded |
| Phase 2 | NCT03960437 | Sep 2018 → Nov 2020 | calcinosis, renal osteodystrophy | Thomas Nickolas, MD MS | Completed | No outcome recorded |
| Phase 2 | NCT01576146 | Mar 2012 → May 2014 | secondary hyperparathyroidism of renal origin | KAI Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01414114 | Dec 2011 → May 2012 | secondary hyperparathyroidism of renal origin | KAI Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01254565 | Feb → Jul 2011 | secondary hyperparathyroidism of renal origin | KAI Pharmaceuticals | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT03969329 | Dec 2019 → Jun 2027 expected | secondary hyperparathyroidism | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT03633708 | Apr 2019 → Jan 2029 expected | chronic kidney disease, secondary hyperparathyroidism of renal origin | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT03299244 | May 2018 → Apr 2020 | chronic kidney disease, secondary hyperparathyroidism | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02102204 | Mar 2014 → Nov 2016 | secondary hyperparathyroidism of renal origin | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01896232 | Aug 2013 → Nov 2014 | chronic kidney disease, secondary hyperparathyroidism of renal origin | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01932970 | Aug 2013 → Jan 2014 | secondary hyperparathyroidism | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01785875 | Jul 2013 → Jul 2015 | secondary hyperparathyroidism of renal origin | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01788046 | Mar 2013 → Apr 2014 | secondary hyperparathyroidism of renal origin | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01785849 | Mar 2013 → May 2014 | secondary hyperparathyroidism | Amgen | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06690242 Comparator | Nov 2024 → Oct 2025 | secondary hyperparathyroidism of renal origin | Shaanxi Micot Pharmaceutical Technology Co., Ltd. | Completed | No outcome recorded |
Press releases naming this drug 11 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-02-07 | Amgen | FDA Approves Amgen's Parsabiv™ (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis amgen.com ↗ |
| 2017-01-10 | Amgen | Study Results Published in the Journal of the American Medical Association Show Amgen's Parsabiv™ (Etelcalcetide) Significantly Reduced Serum Parathyroid Hormone in Adults With Secondary Hyperparathyroidism on Hemodialysis amgen.com ↗ |
| 2016-11-11 | Amgen | European Commission Approves Parsabiv™ (etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adults On Hemodialysis amgen.com ↗ |
| 2016-09-16 | Amgen | Amgen Receives Positive CHMP Opinion For Parsabiv™ (Etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Hemodialysis amgen.com ↗ |
| 2016-08-24 | Amgen | Amgen Provides Update On Status Of Parsabiv™ (Etelcalcetide) New Drug Application (NDA) Submitted To The U.S. Food And Drug Administration (FDA) amgen.com ↗ |
| 2015-11-07 | Amgen | Amgen Presents Detailed Data Comparing Etelcalcetide With Cinacalcet In Patients With Secondary Hyperparathyroidism Receiving Hemodialysis amgen.com ↗ |
| 2015-11-06 | Amgen | FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide amgen.com ↗ |
| 2015-09-02 | Amgen | Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency amgen.com ↗ |
| 2015-08-25 | Amgen | Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) amgen.com ↗ |
| 2015-05-29 | Amgen | Amgen Presents Pooled Phase 3 AMG 416 Data For The Treatment Of Secondary Hyperparathyroidism In Patients With Chronic Kidney Disease amgen.com ↗ |
| 2015-02-25 | Amgen | Amgen Announces Positive Results From Head-To-Head Study Comparing The Efficacy And Safety Of AMG 416 With Cinacalcet In Patients With Secondary Hyperparathyroidism Receiving Hemodialysis amgen.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Etelcalcetide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01785849 ↗ |
| Known as | AMG 416 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | Etelcalcetida | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | ETELCALCETIDE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | KAI-4169 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | KAI-4169 HCl | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | KAI-4169 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | ONO-5163 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | Parsabiv | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | Telcalcetide | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | Telcalcetide hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | Velcalcetide | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Known as | Velcalcetide hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545184 ↗ |
| Action | Activate | “increases sensitivity of the calcium-sensing receptor to calcium” PMID 30859218 ↗ Oct 20201“Calcium sensing receptor agonist” CHEMBL3545184 ↗ |
| Modality | Other / unclassified | “Etelcalcetide is an intravenous calcimimetic that increases sensitivity of the calcium-sensing receptor to calcium and decreases PTH secretion.” PMID 30859218 ↗ Oct 2020 |
| Route | Intravenous | “Administered as a single intravenous (IV) injection” NCT01134549 ↗ |
| Target | CASR | “Calcium sensing receptor agonist” CHEMBL3545184 ↗ |