Myristic Acid Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials sponsored by academic institutions, including Charles University and Osaka University, have evaluated the diagnostic and therapeutic utility of myristic acid for sepsis syndrome, systemic inflammatory response syndrome, and idiopathic triglyceride deposit cardiomyovasculopathy. These studies encompass early-phase interventional research as well as diagnostic evaluations assessing serum myristic acid as an early sepsis biomarker in comparison to procalcitonin and presepsin. All listed trials have achieved completed recruitment status across early-phase and unassigned trial designations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03314831	Completed	Sepsis Syndrome\|Systemic Inflammatory Response Syndrome	Charles University Czech Republic	2017-10-24	--
NCT02502578	Completed	Idiopathic Triglyceride Deposit Cardiomyovasculopathy	Osaka University	2015-09	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Myristic acid acts as a natural fatty acid inhibitor that targets Src kinase with an inhibition constant (Ki) of 35 μM, thereby blocking Src-mediated substrate phosphorylation of poly E4Y and interrupting downstream intracellular signaling. This suppression of Src activity modulates cellular inflammatory and metabolic pathways, underpinning its therapeutic and diagnostic relevance in clinical conditions such as sepsis syndrome and idiopathic triglyceride deposit cardiomyovasculopathy.

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>).