Clinical Trials

Multiple clinical trials evaluate contexts relevant to this compound profile across diverse conditions, including Lynch syndrome, uterine corpus carcinoma (stages I through IV), type 2 diabetes, vestibular disorders, and pediatric acute asthma exacerbations. Encompassing Phase 1/2, Phase 2, unassigned, and non-applicable study designs, these trials are sponsored by academic, government, and industry entities. Across the portfolio, recruitment statuses remain either not yet recruiting or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01199250 Not yet recruiting
Lynch Syndrome|Recurrent Uterine Corpus Carcinoma|Stage I Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation
 2100-01 --
NCT04662164 Withdrawn
Type 2 Diabetes Patients
Shanghai HEP Pharmaceutical Co. Ltd.
 2025-12 Phase 1|Phase 2
NCT06177132 Not yet recruiting
Vestibular Disorder
University Hospital Ghent|University Ghent
 2025-11 Not Applicable
NCT03277170 Not yet recruiting
Asthma; Status|Asthma in Children|Asthma Acute|Asthma Attack|Acute Asthma Exacerbation
Vanderbilt University Medical Center
 2025-09-01 Phase 2

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

Check the 4',7-Dimethoxyisoflavone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4',7-Dimethoxyisoflavone binds key enzymes and structural components in target cells, blocking downstream biosynthetic and signaling pathways to disrupt cellular integrity and inhibit proliferation. This biochemical inhibition underlies its documented antifungal activity and provides a potential mechanistic basis for clinical studies exploring inflammatory conditions and tumor growth in uterine corpus carcinoma.

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>).

Jump to

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