Clinical Trials

Multiple clinical trials evaluate therapeutic applications across diverse conditions, including uterine corpus carcinoma and Lynch syndrome, type 2 diabetes, vestibular disorders, and pediatric acute asthma exacerbations. Spanning early Phase 1/2 safety evaluations, Phase 2 efficacy studies, and non-applicable phase designations, these trials are supported by academic medical centers, government entities such as the National Cancer Institute and Gynecologic Oncology Group Foundation, and industry sponsors like Shanghai HEP Pharmaceutical Co. Ltd. Across these records, reported recruitment statuses consist of not yet recruiting and withdrawn.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NCT04662164 Withdrawn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 Liquiritigenin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Liquiritigenin selectively binds to estrogen receptor beta (ERβ) with an IC50 of 7.5 μM, triggering the activation of ERβ-responsive regulatory elements and native target gene transcription without engaging ERα pathways. This selective modulation alters target cell gene expression profiles and downstream signaling pathways, establishing a biological rationale for evaluating its effect in hormone-sensitive malignancies such as uterine corpus carcinoma as well as inflammatory and metabolic conditions studied 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>).

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