Losartan Carboxylic Acid (EXP-3174) Clinical Trials

Size	Price	Qty
5mg	USD 99

Clinical Trials

Multiple clinical trials sponsored by Hanmi Pharmaceutical Company Limited are currently on record investigating formulations associated with Losartan Carboxylic Acid. Conducted exclusively in healthy volunteers, these Phase 1 studies—which comprise both completed trials and those with an unknown recruitment status—evaluate safety, tolerability, pharmacokinetics, and drug interactions. Consequently, the clinical trial landscape for this compound remains concentrated on preliminary Phase 1 safety and pharmacokinetic evaluations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05407220	Unknown status	Healthy	Hanmi Pharmaceutical Company Limited	2022-06-08	Phase 1
NCT05191563	Completed	Healthy	Hanmi Pharmaceutical Company Limited	2021-07-31	Phase 1
NCT04322266	Completed	Healthy	Hanmi Pharmaceutical Company Limited	2018-12-21	Phase 1
NCT04081844	Completed	Healthy	Hanmi Pharmaceutical Company Limited	2018-05-03	Phase 1

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

Check the Losartan Carboxylic Acid (EXP-3174) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Losartan Carboxylic Acid acts as a potent non-peptide angiotensin II type 1 (AT1) receptor antagonist that selectively blocks angiotensin II binding to vascular smooth muscle cell receptors, thereby inhibiting downstream intracellular signaling cascades to induce vascular relaxation. This target-specific receptor blockade underpins its therapeutic mechanism, providing the physiological rationale for Phase 1 clinical studies evaluating its safety, tolerability, and pharmacokinetic properties in healthy subjects.

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>).