Sasapyrine Clinical Trials

Size	Price	Qty
50mg	USD 79

Clinical Trials

Several clinical trials have evaluated sasapyrine (salsalate) to explore its modulation of inflammatory and metabolic pathways in conditions such as preeclampsia, Alzheimer disease, obesity-related prediabetes, polycystic ovary syndrome, and insulin resistance in schizophrenia. Primarily sponsored by academic and government research institutions, these studies encompass Early Phase 1, Phase 1, Phase 2, and Not Applicable classifications. Recruitment statuses across these trials include completed, terminated, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03482440	Unknown status	Preeclampsia	University of Iowa\|Penn State University	2018-08-26	Early Phase 1
NCT03277573	Unknown status	Alzheimer Disease	Adam Boxer\|University of California San Francisco	2017-07-21	Phase 1
NCT01977417	Terminated	Prediabetes\|Obese	Gary L. Pierce\|University of Iowa	2012-11	Phase 2
NCT01489319	Terminated	Polycystic Ovary Syndrome	Indiana University	2012-02	Phase 1
NCT01182727	Completed	Schizophrenia\|Insulin Resistance	University of Maryland Baltimore\|US Department of Veterans Affairs	2010-08	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sasapyrine (salsalate) functions as a nonsteroidal anti-inflammatory agent that hydrolyzes into salicylic acid to inhibit IκB kinase beta (IKKβ) and cyclooxygenase enzymes, thereby suppressing downstream nuclear factor-kappa B (NF-κB) activation and inflammatory mediator release. This cellular dampening of pro-inflammatory cascades reduces vascular and metabolic stress, mitigating pathological inflammatory responses in clinical conditions such as prediabetes, Alzheimer disease, preeclampsia, and polycystic ovary syndrome.

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>).