E7766 diammonium salt Clinical Trials

Size	Price	Qty
1mg	USD 1,590

Clinical Trials

Multiple Phase 1 clinical trials sponsored by Eisai Inc. and H3 Biomedicine Inc. have evaluated E7766 for oncological conditions, including advanced solid tumors, lymphomas, and urinary bladder neoplasms. Among these studies, an evaluation of intratumoral administration for patients with advanced solid tumors or lymphoma was terminated during recruitment. Additionally, a trial assessing intravesical delivery in subjects with non-muscle invasive bladder cancer unresponsive to BCG therapy was withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04144140	Terminated	Lymphoma\|Advanced Solid Tumors	Eisai Inc.\|H3 Biomedicine Inc.	2020-02-24	Phase 1
NCT04109092	Withdrawn	Urinary Bladder Neoplasms	Eisai Inc.\|H3 Biomedicine Inc.	2020-02-13	Phase 1

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

Check the E7766 diammonium salt product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

E7766 diammonium salt selectively binds to stimulator of interferon genes with high affinity at a Kd of 40 nM, activating downstream TBK1 phosphorylation and IRF3 nuclear translocation. This signaling cascade induces robust type I interferon and cytokine expression to stimulate antitumor immunity, mediating therapeutic relevance in advanced solid tumors, lymphomas, and urinary bladder neoplasms.

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>).