Atopaxar Clinical Trials

Size	Price	Qty
5mg	USD 397
25mg	USD 839

Clinical Trials

A clinical trial evaluating Atopaxar, sponsored by Eisai Inc., has been completed in healthy subjects. This Phase 1 investigation utilized a randomized, double-blind, placebo-controlled design to assess the safety and pharmacokinetic impact of multiple doses of the compound. Overall, the clinical evaluation of Atopaxar focuses on early-stage Phase 1 safety and pharmacokinetic profiling in healthy volunteer populations prior to broader patient cohort studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01241669	Completed	Healthy Subjects	Eisai Inc.	2010-10	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atopaxar selectively and reversibly binds to protease-activated receptor-1 (PAR-1), blocking thrombin-mediated intracellular signaling pathways and calcium mobilization. This inhibition prevents thrombin-induced platelet activation and aggregation, establishing the mechanistic rationale for evaluating its pharmacokinetic and pharmacodynamic profile in healthy subjects during Phase 1 clinical trials.

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>).