Clinical Trials

Several clinical trials evaluate therapeutic applications across diverse conditions, including epidermal nevi and nevus sebaceus, acute exacerbations of chronic obstructive pulmonary disease, post-surgical rehabilitation, and SARS-CoV-2-associated interstitial lung disease. These studies encompass Phase 2, Phase Not Applicable, and unassigned trial designations, with recruitment statuses spanning from not yet recruiting and actively recruiting to completed. The investigations are sponsored by academic institutions, government health agencies, and commercial entities, including Stanford University, Imperial College London, Assistance Publique - Hôpitaux de Paris, and NFlection Therapeutics Inc.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05195762 Not yet recruiting
Epidermal Nevi|Nevus Sebaceus
Albert Chiou|NFlection Therapeutics Inc.|Stanford University
 2023-06 Phase 2
NCT05546606 Recruiting
COPD Acute Exacerbation
Assistance Publique - Hôpitaux de Paris|Ministry of Health France|Xenios AG
 2023-04-18 Not Applicable
NCT06072261 Completed
Rehabilitation
Suleyman Demirel University
 2023-04-15 Not Applicable
NCT05514522 Recruiting
Interstitial Lung Disease|SARS-CoV-2 Infection
Imperial College London|Medical Research Council|University of Nottingham|University of Southampton|University of Leicester|University of Manchester|University of Liverpool|University of Sheffield|University of Oxford|University College London|University of Newcastle Upon-Tyne|University of Edinburgh
 2021-08-18 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isoliquiritin apioside suppresses phorbol 12-myristate 13-acetate-induced activation of mitogen-activated protein kinase and nuclear factor kappa B signaling pathways. This pathway blockade significantly decreases matrix metalloproteinase enzymatic activity, thereby suppressing cellular invasion and angiogenesis without inducing non-specific cytotoxicity. By targeting these key inflammatory and extracellular matrix-remodeling cascades, the compound demonstrates therapeutic relevance for neoplastic conditions and inflammatory respiratory disorders studied in clinical contexts, such as interstitial lung disease and chronic obstructive pulmonary disease.

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.