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Last Updated: March 27, 2026

Claims for Patent: 11,959,486

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Summary for Patent: 11,959,486

Title:	Stable liquid formulation of AMG 416 (etelcalcetide)
Abstract:	A liquid formulation comprising a peptide agonist of the calcium sensing receptor and method of preparing and using the formulation are provided.
Inventor(s):	Derek MacLean, Qun Yin
Assignee:	Amgen Inc
Application Number:	US17/400,044
Patent Claims:	1. A composition, comprising: etelcalcetide in a liquid formulation comprising water, wherein the formulation has a pH of 2.0 to 5.0 and wherein etelcalcetide is present at a concentration of between about 0.5 mg/mL to about 15 mg/mL. 2. The composition of claim 1, wherein etelcalcetide is present at a concentration of between about 0.5 mg/mL to about 10 mg/mL. 3. The composition of claim 2, wherein the formulation has a pH of 2.5 to 4.50. 4. The composition of claim 1, wherein the pH is maintained by a pharmaceutically acceptable buffer. 5. The composition of claim 4, wherein the buffer is succinate. 6. The composition of claim 1, wherein the etelcalcetide is present as etelcalcetide hydrochloride. 7. The composition of claim 1, further comprising a pharmaceutically acceptable tonicity modifier. 8. The composition of claim 7, wherein the tonicity modifier is NaCl. 9. A liquid composition, comprising: between about 0.5 mg/mL to 15 mg/mL of etelcalcetide hydrochloride in aqueous solution, a succinate buffer that maintains at a pH of between about 2.5 to 4.5, and sodium chloride. 10. A method for treating secondary hyperparathyroidism (SHPT), comprising: parenterally administering the composition according to claim 1 to a subject in need thereof. 11. The method of claim 10, wherein parenterally administering is via intravenous injection. 12. The method of claim 10, wherein the composition comprises etelcalcetide hydrochloride. 13. The method of claim 10, wherein the pH is maintained by a pharmaceutically acceptable succinate buffer.

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