Clinical Trials

Several completed clinical trials have evaluated this compound across Phase 1 pharmacokinetic assessments as well as unassigned or non-applicable phase studies. Sponsored by Charite University Berlin Germany, VA Long Beach Healthcare System, and Hua Medicine Limited, these trials involved healthy subjects, patients with type 2 diabetes mellitus, and individuals with cardiovascular conditions such as arterial occlusion and coronary artery disease. Specific study endpoints focused on mass balance, drug disposition in renal or hepatic impairment, arterial hemostasis, and quality-of-life outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04950543 Completed
Quality of Life
Charite University Berlin Germany
 2021-07-05 --
NCT04046952 Completed
Arterial Occlusion|Cardiovascular Diseases|Atherosclerosis|Hematoma|Anticoagulant-induced Bleeding|Coronary Artery Disease
VA Long Beach Healthcare System
 2019-10-10 Not Applicable
NCT04324424 Completed
Type 2 Diabetes Mellitus
Hua Medicine Limited
 2019-04-23 Phase 1
NCT04426708 Completed
Type 2 Diabetes Mellitus
Hua Medicine Limited
 2019-02-18 Phase 1
NCT03158506 Completed
Healthy Subject
Hua Medicine Limited
 2017-03-29 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Homosalate acts as an organic ultraviolet radiation filter that modulates key intracellular signaling cascades, specifically regulating the PI3K/AKT and MAPK pathways to impact trophoblast cellular invasion. By altering these downstream biochemical pathways and cellular dynamics, the compound links photoprotective and cellular regulatory functions to broader metabolic and vascular research contexts, including type 2 diabetes mellitus and cardiovascular conditions investigated in clinical trials.

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>).

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Note: Technical data last updated: Sep 1, 2026.