Ketanserin Clinical Trials

Size	Price	Qty
100mg	USD 197

Clinical Trials

Multiple clinical trials spanning Phase 1 to Phase 4 have evaluated ketanserin across completed, actively recruiting, and terminated recruitment statuses. Primarily sponsored by academic institutions and medical centers such as University Hospital Basel and Rigshospitalet, these studies target diverse indications including severe sepsis, septic shock, acute renal failure, diabetic foot ulcers, microcirculation during critical illness, and receptor dynamics in healthy volunteers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03289949	RECRUITING	Basic Science	Gitte Moos Knudsen	2017-03-03	PHASE1
NCT06796361	RECRUITING	Healthy	University Hospital, Basel, Switzerland	2025-04-21	PHASE1
NCT05964647	COMPLETED	Healthy	University Hospital, Basel, Switzerland	2024-02-01	PHASE1
NCT04849013	COMPLETED	Healthy	University Hospital, Basel, Switzerland	2021-08-11	PHASE1
NCT04558294	COMPLETED	Healthy	University Hospital, Basel, Switzerland	2020-10-16	PHASE1
NCT03646318	UNKNOWN	Critical Illness	Onze Lieve Vrouwe Gasthuis	2018-09-01	PHASE4
NCT03289949	Recruiting	Basic Science	Gitte Moos Knudsen\|Rigshospitalet Denmark	2017-03-03	Phase 1
NCT02451072	COMPLETED	Healthy	Psychiatric University Hospital, Zurich	2015-03
NCT02632877	COMPLETED	Diabetic Foot Ulcer	University of Guadalajara	2014-01	PHASE1; PHASE2
NCT00557219	TERMINATED	Acute Renal Failure	Medical University of Gdansk	2008-04	PHASE3
NCT01329887	COMPLETED	Severe Sepsis; Septic Shock	Frisius Medisch Centrum	2011-03	PHASE3
NCT01329887	Completed	Severe Sepsis\|Septic Shock	Medical Centre Leeuwarden	2011-03	Phase 3

(data from https://clinicaltrials.gov, updated on 2024-12-16)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ketanserin selectively binds to and antagonizes 5-HT2A serotonin receptors, thereby inhibiting downstream G-protein-coupled signaling cascades and serotonin-mediated platelet aggregation. By suppressing serotonin-induced arterial vasoconstriction, this cellular inhibition improves microvascular perfusion, providing therapeutic relevance in conditions such as severe sepsis, septic shock, and acute renal failure.

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>).