Clinical Trials

Several clinical trials are evaluating interventions for uterine corpus carcinoma associated with Lynch syndrome, type 2 diabetes, pediatric acute asthma exacerbations, and vestibular disorders. Spanning Phase 1/2, Phase 2, and unassigned phase classifications, these studies are sponsored by academic, federal, and commercial entities, including the National Cancer Institute, Vanderbilt University Medical Center, Shanghai HEP Pharmaceutical Co. Ltd., and University Hospital Ghent. Across these protocols, recruitment statuses are currently recorded as either not yet recruiting or withdrawn.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NCT04662164 Withdrawn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'-Hydroxychalcone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4'-Hydroxychalcone inhibits tumor necrosis factor-alpha (TNFα)-induced nuclear factor kappa B (NF-κB) pathway activation while concurrently stimulating bone morphogenetic protein (BMP) signaling. By blocking downstream transcription of pro-inflammatory gene networks and modulating cell differentiation cascade activity, the compound exerts anti-inflammatory and antiproliferative effects relevant to clinical research in acute asthma exacerbations and uterine malignancies.

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>).

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