i-Inositol Clinical Trials

Size	Price	Qty
100mg	USD 147
500mg	USD 347

Clinical Trials

Multiple clinical trials are evaluating i-inositol for various neuropsychiatric, metabolic, and endocrine conditions, including major depression, anxiety, pediatric bipolar disorder, age-related cognitive decline, spinal cord injury-associated neuropathic pain, and fertility disorders in Hodgkin lymphoma survivors. Spanning early-phase interventional and observational designs, these studies are supported by academic, philanthropic, and commercial sponsors such as the University of Pittsburgh and Jarrow Formulas Inc. Recorded recruitment statuses across these investigations encompass active, recruiting, completed, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02811133	Withdrawn	Bipolar Disorder\|Anxiety Disorders\|Anxiety	Ronald M. Glick MD\|The Fine Foundation\|Jarrow Formulas Inc\|University of Pittsburgh	2023-08	Phase 1\|Phase 2
NCT05777863	Active not recruiting	Life Style\|Risk Reduction\|Cognitive Decline\|Aging	Donders Centre for Cognitive Neuroimaging\|Wageningen University and Research	2022-05-10	Not Applicable
NCT05497414	Recruiting	Major Depression	Boston University Charles River Campus\|One Mind\|Brain & Behavior Research Foundation\|1907 Foundation	2022-01-31	Not Applicable
NCT05098587	Completed	Spinal Cord Injuries\|Neuropathic Pain	Swiss Paraplegic Research Nottwil\|Haute Ecole de Santé Vaud	2021-08-30	--
NCT05410314	Completed	Lymphoma Hodgkin\|Menstrual Irregularity\|Fertility Disorders	University of Bari Aldo Moro	2020-02-07	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

i-Inositol serves as a primary precursor for phosphatidylinositol synthesis and second messenger inositol trisphosphate generation, facilitating intracellular calcium mobilization and downstream insulin and neurotransmitter signal transduction pathway activation. By restoring intracellular second messenger signaling dynamics and cellular metabolic homeostasis, this compound modulates central neurochemical transmission and endocrine regulation, directly underlying its clinical evaluation in major depression, anxiety, cognitive decline, and reproductive disorders.

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>).