Divalproex Sodium Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Several early-phase clinical trials have evaluated divalproex sodium in healthy volunteers and patients with neurological or psychiatric conditions, including schizophrenia, bipolar disorder, psychotic disorders, and epilepsy. Sponsored by pharmaceutical companies such as Johnson & Johnson Pharmaceutical Research & Development L.L.C. and Dr. Reddy's Laboratories Limited, these completed Phase I studies specifically investigated drug-drug interactions and bioequivalence formulations to optimize therapeutic delivery.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01094249	Completed	Schizophrenia\|Bipolar Disorder\|Psychotic Disorders	Johnson & Johnson Pharmaceutical Research & Development L.L.C.	2009-02	Phase 1
NCT01060228	Completed	Schizophrenia\|Epilepsy	Johnson & Johnson Pharmaceutical Research & Development L.L.C.	2009-01	Phase 1
NCT01055938	Completed	Healthy	Dr. Reddy''s Laboratories Limited	2006-12	Phase 1
NCT01056627	Completed	Healthy	Dr. Reddy''s Laboratories Limited	2006-12	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Divalproex sodium inhibits histone deacetylases and increases brain levels of gamma-aminobutyric acid, thereby dampening excessive neuronal depolarization and stabilizing synaptic transmission. This suppression of hyper-excitable central nervous signaling reduces abnormal brain activity, underlying its clinical application in treating epilepsy, bipolar disorder, and related psychotic conditions.

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>).