Squalene Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate squalene and squalene-containing formulations across indications including pediatric malnutrition, essential fatty acid deficiency, digestive health, COVID-19, influenza, and healthy volunteer cohorts. Spanning early-phase immunogenicity evaluations to late-phase therapeutic studies and non-phased designs, these protocols are sponsored by pharmaceutical corporations, biotechnology entities, research institutes, and academic centers such as Imperial College London and Tufts University. Protocol statuses across these studies remain heterogeneous, encompassing completed, terminated, and withdrawn trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05035680	WITHDRAWN	Influenza	Gates Medical Research Institute	2022-07-14	PHASE1
NCT05228314	COMPLETED	COVID-19	Clover Biopharmaceuticals AUS Pty	2022-05-30	PHASE1
NCT04753892	COMPLETED	Healthy	Imperial College London	2021-09-10
NCT04555044	Completed	Essential Fatty Acid Deficiency (EFAD)	Baxter Healthcare Corporation	2021-01-22	Phase 4
NCT03563222	Terminated	Malnutrition Child	Fresenius Kabi	2019-12-18	Phase 4
NCT02476994	Terminated	Essential Fatty Acid Deficiency (EFAD)	Baxter Healthcare Corporation	2015-05	Phase 4
NCT01397604	COMPLETED	Healthy Volunteers	Rockefeller University	2011-07	PHASE1
NCT01902394	Completed	Digestive Health and Immune Function	Tufts University\|General Mills\|Tufts Medical Center	2012-06	Not Applicable

(data from https://clinicaltrials.gov, updated on 2022-11-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a naturally occurring lipophilic triterpene and essential intermediate in sterol biosynthesis, squalene functions in emulsion adjuvants to promote antigen retention and enhance localized cellular uptake by antigen-presenting cells. This cellular activation triggers downstream recruitment of immune pathways and potentiation of neutralizing antibody responses, providing key immunological support in clinical trials investigating vaccines for viral infections like COVID-19 and influenza.

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>).