Fosphenytoin (disodium) Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

A Phase IV clinical trial sponsored by Dhaka Medical College is evaluating the comparative efficacy and safety of fosphenytoin versus levetiracetam for the acute management of convulsive status epilepticus. Currently enrolling by invitation, this study highlights the ongoing evaluation of fosphenytoin as a vital therapeutic intervention for emergency seizure control.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06403150	Enrolling by invitation	Status Epilepticus	Dhaka Medical College	2023-05-15	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fosphenytoin (disodium) is a water-soluble prodrug that undergoes rapid systemic hydrolysis by endogenous phosphatases to generate active phenytoin, which selectively stabilizes the inactivated state of neuronal voltage-gated sodium channels. This prolonged channel inactivation prevents high-frequency repetitive action potential firing, directly suppressing central nervous system hyperexcitability to control acute seizures in patients suffering from status epilepticus.

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>).