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 · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-renal secondary hyperparathyroidism 3 milestones | |||||
| Rejected (CRL) | US (FDA) | Parsabiv | non-renal secondary hyperparathyroidism | 2016-08-24 | “FDA has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv ™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT)” amgen.com ↗ |
| Filed | EU (EMA) | — | non-renal secondary hyperparathyroidism | 2015-09-02 | “submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for etelcalcetide” amgen.com ↗ |
| Filed | US (FDA) | — | non-renal secondary hyperparathyroidism | 2015-08-25 | “submission of a New Drug Application (NDA) with the United States Food and Drug Administration ( FDA ) for etelcalcetide” amgen.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | PARSABIV | — | 2017-02-07 | fda.gov ↗ |
| Approved | EU (EMA) | Parsabiv | — | 2016-11-11 | europa.eu ↗ |
Trials 19
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 39 trials · 2 met primary | ||||||
| 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 | NCT01785849 | Mar 2013 → May 2014 | secondary hyperparathyroidism | Amgen | Completed | Met primary |
| Phase 3 | NCT01788046 | Mar 2013 → Apr 2014 | secondary hyperparathyroidism of renal origin | Amgen | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT06690242 Comparator | Nov 2024 → Oct 2025 | secondary hyperparathyroidism of renal origin | Shaanxi Micot Pharmaceutical Technology Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2017-02-07 | Amgen | Regulatory FDA Approves Amgen's Parsabiv™ (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. |
| 2017-01-10 | Amgen | Results 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 ↗
The studies evaluated Parsabiv in more than 1,700 adults with secondary hyperparathyroidism (sHPT) on hemodialysis and showed that the drug produced statistically significant and clinically meaningful reductions in serum parathyroid hormone (PTH) levels, a key marker of sHPT. |
| 2016-11-11 | Amgen | Regulatory European Commission Approves Parsabiv™ (etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adults On Hemodialysis amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted marketing authorization for Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. |
| 2016-09-16 | Amgen | Regulatory 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 ↗
Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of Parsabiv™ (etelcalcetide), recommending approval for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. |
| 2016-08-24 | Amgen | Regulatory Amgen Provides Update On Status Of Parsabiv™ (Etelcalcetide) New Drug Application (NDA) Submitted To The U.S. Food And Drug Administration (FDA) amgen.com ↗
Amgen (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv ™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. |
| 2015-11-07 | Amgen | Results Amgen Presents Detailed Data Comparing Etelcalcetide With Cinacalcet In Patients With Secondary Hyperparathyroidism Receiving Hemodialysis amgen.com ↗
There was no difference between the treatment arms in the mean number of days of vomiting or nausea per week |
| 2015-11-06 | Amgen | Regulatory FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has accepted for review Amgen's New Drug Application (NDA) for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. |
| 2015-09-02 | Amgen | Regulatory Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency amgen.com ↗
The MAA submission for etelcalcetide includes data from three Phase 3 studies, all of which met their primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study evaluating etelcalcetide compared with cinacalcet. |
| 2015-08-25 | Amgen | Regulatory Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) amgen.com ↗
Amgen (NASDAQ: AMGN) today announced the submission of a New Drug Application (NDA) with the United States Food and Drug Administration ( FDA ) for etelcalcetide (formerly AMG 416) |
All press releases naming this drug 11 releases
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 ↗ |