Fulacimstat Clinical Trials

Size	Price	Qty
5mg	USD 677
25mg	USD 1,970

Clinical Trials

The clinical trial landscape for Fulacimstat (BAY 1142524) includes a clinical trial sponsored by Bayer. This completed Phase 1 study evaluated the safety, tolerability, and pharmacokinetic properties of an oral tablet formulation in male and female subjects, with a specific focus on individuals exhibiting renal impairment. Consequently, research for this compound remains centered on early-stage safety and pharmacological profiles in key patient cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03402438	Completed	Clinical Trial Phase I	Bayer	2018-02-12	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fulacimstat is a potent, orally active chymase inhibitor that selectively targets human and hamster chymase enzymes, blocking chymase-mediated enzymatic cleavage and downstream inflammatory peptide cascades. By reducing local angiotensin II generation and suppressing cellular matrix degradation, this inhibition limits cardiovascular and renal tissue damage, supporting its Phase 1 clinical evaluation for safety and pharmacokinetics in subjects with 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>).