Isopropyl myristate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials evaluate formulations involving isopropyl myristate across Phase 1 and non-applicable phase designs, with recruitment statuses ranging from recruiting and completed to unknown. These studies investigate conditions including advanced hepatocellular carcinoma, advanced solid tumors, pancreatic cancer, and pediatric environmental exposure risk reduction. Sponsors comprise academic and public research institutions, medical centers, and commercial pharmaceutical developers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05981066	Recruiting	Advanced Hepatocellular Carcinoma	Peking Union Medical College Hospital	2023-07-10	Not Applicable
NCT03319927	Recruiting	Children Only\|Risk Reduction\|Environmental Exposure	University of California San Francisco\|National Institute of Environmental Health Sciences (NIEHS)\|University of California Berkeley\|Oregon State University	2017-10-09	Not Applicable
NCT02020226	Unknown status	Solid Tumors	Threshold Pharmaceuticals	2013-11	Phase 1
NCT01833546	Completed	Solid Tumor\|Pancreatic Cancer	Merck KGaA Darmstadt Germany\|Threshold Pharmaceuticals	2013-04-18	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isopropyl myristate acts as a lipophilic penetration enhancer that directly intercalates into stratum corneum lipid membranes, inducing lamellar lipid bilayer perturbation and structural disordering. By fluidizing epidermal lipid barriers and facilitating active compound solubilization, it increases cutaneous absorption and transdermal bioavailability, thereby supporting enhanced therapeutic agent delivery in trial conditions such as advanced solid tumors and environmental risk-reduction applications.

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>).