J147 Clinical Trials

Size	Price	Qty
10mg	USD 97

Clinical Trials

Multiple clinical trials sponsored by Abrexa Pharmaceuticals, Inc. are evaluating the therapeutic potential of J147 for neurodegenerative and cerebrovascular conditions. A completed Phase 1 study investigated the safety, tolerability, and pharmacokinetics of oral J147 in patients with Alzheimer's disease. Additionally, a Phase 2 trial is actively recruiting participants to assess the efficacy and safety of intravenous J147 combined with endovascular treatment for acute ischemic stroke.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07430917	RECRUITING	Acute Ischemic Stroke	Abrexa Pharmaceuticals, Inc.	2026-07-22	PHASE2
NCT03838185	COMPLETED	Alzheimer's Disease	Abrexa Pharmaceuticals, Inc.	2019-01-22	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the J147 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

J147 acts by binding to mitochondrial ATP synthase, modulating downstream intracellular signaling pathways to reduce oxidative stress and promote neurogenesis. This neuroprotective mechanism provides the biological rationale for evaluating J147 in clinical trials for Alzheimer's disease and acute ischemic stroke.

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>).