FX1 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 470

Clinical Trials

Sponsored by Bristol-Myers Squibb, a clinical trial evaluated the safety, pharmacokinetics, and tolerability of this compound in participants with end-stage renal disease undergoing chronic stable hemodialysis. This completed Phase 1 study focused on conditions associated with thrombosis, Factor XI, and renal impairment to provide initial human drug disposition data. Overall, clinical evaluation of this therapeutic remains centered on completed Phase 1 evidence in patient populations with severe renal dysfunction and thrombotic risk.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02902679	Completed	Thrombosis\|Factor XI\|Renal Impairment\|ESRD (End-Stage Renal Disease)	Bristol-Myers Squibb	2016-11	Phase 1

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

Check the FX1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

FX1 selectively binds to the BTB domain of BCL6, blocking downstream transcriptional repressor activity and inducing cell apoptosis. This inhibition of target repressor function provides therapeutic relevance for mitigating pathological cellular responses in clinical conditions such as thrombosis, Factor XI dysregulation, and renal impairment.

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>).