Evocalcet Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

A completed Phase 1/Phase 2 clinical trial sponsored by Kyowa Kirin Co., Ltd. evaluated the therapeutic potential of evocalcet (KHK7580) in patients with secondary hyperparathyroidism receiving hemodialysis. This industry-funded study examined single and multiple dose escalations of the investigational agent. Overall, the clinical research on evocalcet reflects a targeted early-phase development effort focused on managing hyperparathyroidism.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01935856	Completed	Hyperparathyroidism	Kyowa Kirin Co. Ltd.	2013-08	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Evocalcet product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Evocalcet acts as an oral calcimimetic that allosterically activates the calcium-sensing receptor (CaSR), increasing receptor sensitivity to extracellular calcium and driving dose-dependent elevations in cytoplasmic calcium concentrations. This activation of CaSR signaling suppresses parathyroid hormone secretion, providing therapeutic benefit in the clinical management of hyperparathyroidism.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).