Clinical Trials

A clinical trial sponsored by Yonsei University is evaluating diagnostic monitoring strategies in patients with hypertrophic cardiomyopathy requiring extended cardiac observation. Presently not yet recruiting, this Phase 3 academic study aims to assess the diagnostic efficacy and safety of a wearable continuous electrocardiogram patch device compared to standard monitoring. This late-stage study comprises the registered clinical trial landscape for this targeted indication.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06873828 NOT_YET_RECRUITING
Hypertrophic Cardiomyopathy
Yonsei University
 2025-03 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-03-13)

Check the C75 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

C75 functions as a synthetic inhibitor of fatty acid synthase and an activator of carnitine palmitoyltransferase 1A, directly altering intracellular lipid metabolism by blocking de novo fatty acid synthesis while promoting mitochondrial beta-oxidation. This dual enzymatic modulation alters cellular bioenergetics and lipid signaling pathways, leading to suppressed cell proliferation and metabolic adaptation relevant to oncologic pathways and cardiac pathologies such as hypertrophic cardiomyopathy.

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.