Sal003 Clinical Trials

Size	Price	Qty
10mg	USD 247
25mg	USD 370

Clinical Trials

Multiple Phase 2 and Phase 3 multicenter clinical trials sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd. have evaluated this compound for metabolic lipid disorders, specifically targeting hyperlipidemias, hypercholesterolemia, and mixed dyslipidemia. These studies assessed both monotherapy and combination therapeutic approaches and have all completed recruitment. Together, they provide essential safety and efficacy data supporting the compound's clinical profile in cardiovascular and metabolic medicine.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07253584	COMPLETED	Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia	Shenzhen Salubris Pharmaceuticals Co., Ltd.	2023-12-19	PHASE3
NCT07295418	COMPLETED	Hyperlipidemias	Shenzhen Salubris Pharmaceuticals Co., Ltd.	2023-10-23	PHASE3
NCT07278830	COMPLETED	Hypercholesterolemia and Mixed Dyslipidemia	Shenzhen Salubris Pharmaceuticals Co., Ltd.	2023-06-02	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-11-28)

Check the Sal003 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sal003 acts as a potent, cell-permeable inhibitor of eukaryotic initiation factor 2α (eIF-2α) phosphatase, preventing the dephosphorylation of eIF-2α and suppressing downstream translational biochemistry. This targeted cellular inhibition modulates endoplasmic reticulum stress responses and metabolic signaling pathways, providing a biological mechanism relevant to its clinical evaluation in hyperlipidemias, hypercholesterolemia, and mixed dyslipidemia.

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>).