Clinical Trials

A completed Phase 2 clinical trial, sponsored by the AdventHealth Translational Research Institute, evaluated the therapeutic potential of Abscisic Acid for human metabolic health. The study investigated how supplementation with this natural hormone influences systemic glucose homeostasis and insulin sensitivity in individuals with prediabetes. Consequently, clinical research on Abscisic Acid remains focused on mid-stage evaluations for managing prediabetic and metabolic conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04722354 COMPLETED
Pre Diabetes
AdventHealth Translational Research Institute
2021-03-08 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-09)

Check the Abscisic Acid (Dormin) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Abscisic Acid acts as an endogenous signaling molecule that binds to target receptor complexes, thereby modulating downstream cellular metabolic pathways and ion homeostasis. By regulating intracellular signaling cascades that facilitate glucose uptake and cellular metabolic homeostasis, this hormone helps maintain systemic glycemic control, directly supporting its therapeutic evaluation in prediabetes.

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.