Clinical Trials

Several clinical trials sponsored by Boryung Pharmaceutical Co. Ltd. have evaluated fimasartan across Phase I pharmacokinetic and safety assessments as well as observational studies. These completed trials focused on conditions such as hypertension, combined hypertension and hyperlipidemia, and hypertension associated with ischemic stroke or transient ischemic attack. Overall, these efforts reflect clinical evaluation targeting cardiovascular and cerebrovascular manifestations linked to elevated blood pressure.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02994745 Completed
Hypertension Hyperlipidemia
Boryung Pharmaceutical Co. Ltd
 2016-12-23 Phase 1
NCT02920047 Completed
Hypertension
Boryung Pharmaceutical Co. Ltd
 2016-10 Phase 1
NCT02995720 Completed
Hypertension Hyperlipidemia
Boryung Pharmaceutical Co. Ltd
 2016-08-26 Phase 1
NCT03231293 Completed
Hypertension|Ischemic Stroke|Transient Ischemic Attack
Boryung Pharmaceutical Co. Ltd
 2016-07-28 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fimasartan is a non-peptide angiotensin II receptor antagonist that displays noncompetitive, insurmountable binding to the AT1 receptor, thereby blocking downstream angiotensin II-induced signaling cascades and vasoconstriction. By suppressing vascular smooth muscle contraction and reducing systemic peripheral resistance, fimasartan lowers blood pressure, providing direct therapeutic efficacy in managing hypertension and associated cardiovascular or cerebrovascular risks.

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>).

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Note: Technical data last updated: Sep 1, 2026.