Zotarolimus (ABT-578) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials, encompassing completed Phase 3 and Phase 4 studies alongside registry evaluations, have evaluated zotarolimus for cardiovascular conditions such as acute coronary syndrome, coronary artery disease, ischemic heart disease, and comorbid hypertension and diabetes. Conducted through collaborations between industry leaders like Medtronic Vascular and academic medical centers including Yonsei University and IRCCS San Raffaele, these studies investigated zotarolimus-eluting stent implantation, focusing on neointimal coverage, platelet activity, and long-term cardiovascular outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01239654	Completed	Acute Coronary Syndrome	IRCCS San Raffaele\|Mediolanum Cardio Research\|Cardiovascular Research Foundation New York	2010-09	Phase 3
NCT01003717	Completed	Coronary Artery Disease	Rebecca Torguson\|Medstar Health Research Institute	2009-10	--
NCT00846846	Completed	Coronary Artery Disease Autosomal Dominant 1	Medtronic Vascular	2009-01	Phase 4
NCT00815139	Completed	Coronary Artery Disease	Yonsei University	2008-02	--
NCT00599885	Completed	Hypertension\|Diabetes\|Coronary Artery Disease	Korea University Anam Hospital	2007-09	Phase 4
NCT00476957	Completed	Ischemic Heart Disease	Medtronic Vascular\|Medtronic Bakken Research Center	2007-06	Phase 4

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

Check the Zotarolimus (ABT-578) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zotarolimus binds to FK506-binding protein 12 (FKBP-12) with high affinity, forming a complex that inhibits mammalian target of rapamycin (mTOR) downstream signaling to suppress vascular smooth muscle cell proliferation and neointimal growth. This anti-proliferative action provides the mechanistic basis for deploying zotarolimus-eluting stents to reduce re-occlusion and improve outcomes in clinical trials for patients with coronary artery disease, acute coronary syndrome, and ischemic heart disease.

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>).