E7046 (ER-886406) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials sponsored by industry entities, including Eisai Inc. and Adlai Nortye Biopharma Co., Ltd., have evaluated E7046 for the treatment of advanced solid tumors and rectal cancer. Eisai Inc. conducted a Phase I study in patients with selected advanced malignancies, which was ultimately terminated. Conversely, Adlai Nortye Biopharma completed a Phase Ib trial evaluating E7046 combined with radiotherapy or chemoradiotherapy as preoperative neoadjuvant treatment for rectal cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03152370	COMPLETED	Neoadjuvant Therapy in Rectal Cancer	Adlai Nortye Biopharma Co., Ltd.	2017-05-17	PHASE1
NCT02540291	TERMINATED	Tumors	Eisai Inc.	2015-07-30	PHASE1
NCT02540291	Terminated	Tumors	Eisai Inc.	2015-07-30	Phase 1

(data from https://clinicaltrials.gov, updated on 2021-10-04)

Check the E7046 (ER-886406) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

E7046 functions as a selective small-molecule inhibitor that binds to the prostaglandin E2 receptor EP4, blocking downstream cyclic adenosine monophosphate signaling and PGE2-mediated immunosuppressive pathways in the tumor microenvironment. By reversing EP4-mediated immune suppression, E7046 enhances anti-tumor immune cell activity, demonstrating therapeutic potential against advanced malignancies and supporting its investigation in rectal cancer regimens.

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>).