Clinical Trials

Multiple clinical trials are currently recruiting participants to evaluate interventions for conditions associated with this profile, specifically pediatric functional abdominal pain syndrome and functional rehabilitation following acute stroke. Encompassing Phase 4 and phase-not-applicable studies, these trials are sponsored by academic and hospital organizations, including Prince of Songkla University, Sunnyview Rehabilitation Hospital, and Gaylord Hospital.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06310733 Recruiting
Functional Abdominal Pain Syndrome
Prince of Songkla University
 2024-03-21 Phase 4
NCT05401799 Recruiting
Stroke|Stroke Acute|Cerebral Vascular Accident|Cerebral Vascular Accident (CVA)/Stroke
Sunnyview Rehabilitation Hospital|Gaylord Hospital
 2022-09-01 Not Applicable

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

Check the Genipin 1-O-beta-D-gentiobioside product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Genipin 1-O-beta-D-gentiobioside functions as a bioactive iridoid glycoside that suppresses pro-inflammatory signaling pathways and reactive oxygen species production, thereby reducing cellular oxidative damage and inflammatory mediator release. This inhibition of systemic inflammation and oxidative stress provides a mechanistic basis for ameliorating tissue injury in acute stroke and alleviating symptoms in functional abdominal pain syndrome.

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.