Diethyl phosphate Clinical Trials

Size	Price	Qty
25mg	USD 99

Clinical Trials

A Phase 3 clinical trial sponsored by EMS is evaluating the therapeutic efficacy and safety of Diethyl phosphate (DEP114) for the treatment of moderate to severe allergic rhinitis. Currently listed as not yet recruiting, this multicenter, double-blind, parallel-group study aims to assess patient outcomes and establish the compound's utility in managing respiratory allergic conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06272409	Not yet recruiting	Allergic Rhinitis	EMS	2025-02-15	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diethyl phosphate modulates the gut microbial environment by selectively enriching opportunistic pathogens, leading to downstream suppression of pro-inflammatory signaling pathways and a reduction in interleukin-6 levels. This alteration in systemic inflammatory and cytokine responses provides the biological rationale for its investigation in treating allergic rhinitis.

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>).