Varespladib (LY315920) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 770

Clinical Trials

Varespladib has been evaluated in multiple Phase 1 to Phase 3 clinical trials sponsored by organizations such as Anthera Pharmaceuticals, Ophirex, Inc., and the University Health Network, Toronto. These studies examined diverse indications—including acute coronary syndrome, snakebite envenoming, sickle cell vaso-occlusive crisis, COVID-19, and renal impairment—alongside pharmacokinetic evaluations in healthy volunteers. While several early- and late-stage studies, such as a Phase 2 snake envenomation trial, reached completion, others including the Phase 3 VISTA-16 study were terminated prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05717062	COMPLETED	Snakebite; Envenoming, Snake	Ophirex, Inc.	2023-05-30	PHASE2
NCT04996264	COMPLETED	Snakebites; Envenoming; Envenoming, Snake; Envenomation, Snake	Ophirex, Inc.	2021-08-15	PHASE2
NCT04969991	TERMINATED	Coronavirus Disease 2019; Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2	Ophirex, Inc.	2021-06-30	PHASE2
NCT01359579	TERMINATED	Renal Impairment	Anthera Pharmaceuticals	2011-06	PHASE1
NCT01522196	TERMINATED	Sickle Cell Disease; Vaso-occlusive Crisis	Anthera Pharmaceuticals	2012-02	PHASE2
NCT01130246	TERMINATED	Acute Coronary Syndrome	Anthera Pharmaceuticals	2010-05	PHASE3
NCT01359605	COMPLETED	Healthy Volunteers	Anthera Pharmaceuticals	2011-06	PHASE1
NCT01359605	Completed	Healthy Volunteers	Anthera Pharmaceuticals	2011-06	Phase 1
NCT01359579	Terminated	Renal Impairment	Anthera Pharmaceuticals	2011-06	Phase 1
NCT00743925	COMPLETED	Acute Coronary Syndrome	Anthera Pharmaceuticals	2008-07	PHASE2
NCT00434473	COMPLETED	Sickle Cell Disease; Vaso-occlusive Crisis; Acute Chest Syndrome	Anthera Pharmaceuticals	2006-12	PHASE2
NCT00533039	COMPLETED	Coronary Artery Disease	University Health Network, Toronto	2007-10	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-06-27)

Check the Varespladib (LY315920) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Varespladib acts as a potent, selective inhibitor of human non-pancreatic secretory phospholipase A2 (sPLA2), binding to the enzyme to block the cleavage of membrane phospholipids and suppress downstream release of inflammatory lipid mediators such as thromboxane A2. By suppressing sPLA2-mediated lipid signaling and tissue injury, this mechanism mitigates vascular inflammation and venom toxicity, providing the biological rationale for its clinical evaluation in acute coronary syndromes, sickle cell crisis, and snakebite envenomation.

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>).