etelcalcetide

Trade name: parsabiv

Peptideapproved

Approved

Feb 7, 2017

Etelcalcetide (formerly velcalcetide, trade name Parsabiv) is a calcimimetic drug for the treatment of secondary hyperparathyroidism in patients undergoing hemodialysis. Etelcalcetide was approved (trade name Parsabiv) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis in February, 2017. Etelcalcetide is a synthetic peptide calcium-sensing receptor agonist. It allosterically modulates the calcium-sensing receptor (CaSR). Etelcalcetide binds to the CaSR and enhances activation of the receptor by extracellular calcium. Activation of the CaSR on parathyroid chief cells decreases PTH secretion. — NCATS

Clinical trial activity

20 trials · 6 clinical orgs · 2 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jun 9, 2010 (NCT01134549)

Timeline

2010s

Jan 1, 2010
KAI Pharmaceuticals — Earliest Phase 1 Sponsor(trial)
Jan 1, 2011
KAI Pharmaceuticals — Earliest Phase 2 Sponsor(trial)
Jan 1, 2013
Amgen — Earliest Phase 3 Sponsor(trial)
Feb 7, 2017
Amgen — Earliest FDA Approval
Feb 7, 2017
KAI Pharmaceuticals — NDA Secondary Org
Feb 7, 2017
Amgen — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Calcium sensing receptorAGONIST
CASR agonist
Peptide
- Extracellular calcium-sensing receptor (CASR) ↗
Calcium sensing receptorINHIBITOR
CASR inhibitor
- Extracellular calcium-sensing receptor (CASR) ↗

Approval history

approvedFeb 7, 2017

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)N[C@H](CSSC[C@H](N)C(=O)O)C(=O)N[C@H](C)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](C)C(=O)N[C@H](CCCNC(=N)N)C(N)=O

Mol. weight: 1048.27 g/mol
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only
Multi-specific: No

Oral

Parenteral

Yes

Topical

Black box warning

Sources

Also known as

amg 416
amg 416
amg 416
amg 416
amg-416
amg-416
amg-416
etelcalcetide
etelcalcetide
etelcalcetide
etelcalcetide
etelcalcetide
etelcalcetide
etelcalcetide
etelcalcetide
etelcalcetide
etelcalcetide hcl
etelcalcetide hydrochloride
etelcalcetide hydrochloride
etelcalcitide
kai-4169
kai-4169
kai-4169
kai-4169
kai-4169
parsabiv
parsabiv
parsabiv
parsabiv
velcalcetide
velcalcetide
velcalcetide
velcalcetide
velcalcetide
velcalcetide hydrochloride

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06690242	Phase 2	Nov 18, 2024	Shaanxi Micot Technology Limited Company
NCT03969329	Phase 3	Nov 4, 2019	Amgen
NCT03795558	Phase 2	May 1, 2019	Amgen, KH Elisabethinen Linz
NCT03633708	Phase 3	Dec 29, 2018	Amgen
NCT03960437	Phase 2	Sep 6, 2018	Columbia University
NCT03299244	Phase 3	May 15, 2018	Amgen
NCT03283098	Phase 1	Mar 1, 2018	Amgen
NCT02833857	Phase 1	Mar 14, 2017	Amgen
NCT02102204	Phase 3	Mar 25, 2014	Amgen
NCT02054572	Phase 1	Feb 7, 2014	Amgen
NCT01932970	Phase 3	Aug 1, 2013	Amgen
NCT01896232	Phase 3	Aug 1, 2013	Amgen
NCT01785875	Phase 3	Jul 1, 2013	Amgen
NCT01788046	Phase 3	Mar 1, 2013	Amgen
NCT01785849	Phase 3	Mar 1, 2013	Amgen
NCT01576146	Phase 2	Mar 1, 2012	Amgen, KAI Pharmaceuticals
NCT01414114	Phase 2	Dec 5, 2011	KAI Pharmaceuticals
NCT01254565	Phase 2	Feb 20, 2011	Amgen, KAI Pharmaceuticals
NCT01134562	Phase 1	Aug 1, 2010	KAI Pharmaceuticals
NCT01134549	Phase 1	Jun 9, 2010	Amgen, KAI Pharmaceuticals, Nucleus Network Ltd

Showing 20 of 20 trials

Page 1 / 1

Organizations

Research & Development (6)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Amgen	For profit	16	12	3	2010
KAI Pharmaceuticals	For profit	5	5	2	2010
Columbia University	Academic/Hospital	1	1	1	2018
KH Elisabethinen Linz	Academic/Hospital	1	1	1	2019
Nucleus Network Ltd	For profit	1	0	1	2010
Shaanxi Micot Technology Limited Company	For profit	1	1	1	2024

6 organizations

Page 1 / 1

Marketing (2)

Organization	Org type	Relationship	Date
Amgen	For profit	NDA	Feb 7, 2017
KAI Pharmaceuticals	For profit	NDA2	Feb 7, 2017