Elraglusib Clinical Trials

Size	Price	Qty
5mg	USD 177
25mg	USD 537

Clinical Trials

Several clinical trials evaluate the therapeutic potential of the small-molecule GSK-3 inhibitor elraglusib across Phase 1 and Phase 2 settings for advanced solid tumors, pancreatic adenocarcinoma, and metastatic pancreatic adenocarcinoma. Sponsored by industry partner Actuate Therapeutics Inc. alongside clinical investigators such as Anwaar Saeed and Colin D. Weekes, these studies display varied recruitment statuses, including recruiting, active, not recruiting, and not yet recruiting. Together, these early-phase investigations assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of elraglusib-containing regimens.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07714395	NOT_YET_RECRUITING	Advanced Malignant Solid Tumor	Actuate Therapeutics Inc.	2026-10	PHASE1; PHASE2
NCT06896188	RECRUITING	Pancreatic Adenocarcinoma	Anwaar Saeed	2025-09-22	PHASE1
NCT05077800	ACTIVE_NOT_RECRUITING	Pancreatic Adenocarcinoma; Pancreatic Adenocarcinoma Metastatic	Colin D. Weekes, M.D., PhD	2022-03-21	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Elraglusib functions as a potent inhibitor of glycogen synthase kinase-3 (GSK-3), specifically targeting centrosome- and microtubule-bound GSK-3β to disrupt downstream biochemical signaling cascades. This targeted inhibition triggers cell cycle arrest at prophase and induces programmed cell death in malignant cells, providing a mechanistically driven therapeutic approach for treating advanced malignant solid tumors and pancreatic adenocarcinoma.

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>).