Enalaprilat Dihydrate Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials across Phase 2 through Phase 4 evaluate enalaprilat dihydrate for cardiovascular and metabolic conditions, including heart failure, hypertension, dilated cardiomyopathy, congenital heart disease, type 2 diabetes, and orthostatic hypotension. Sponsored by academic and institutional entities such as the University of Michigan, Vanderbilt University, Ethicare GmbH, and the VA Office of Research and Development, these studies encompass completed, active non-recruiting, withdrawn, and unknown recruitment statuses. Overall, these investigations underscore the drug's therapeutic relevance in managing cardiovascular dysfunction and related metabolic disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05259137	WITHDRAWN	Hypertrophic Scar	Nova Scotia Health Authority	2024-08	PHASE2; PHASE3
NCT04640571	COMPLETED	Bile Salt Export Pump (BSEP) Transporter; Polysorbate 80	University of Maryland, Baltimore	2021-04-01	PHASE4
NCT02639637	COMPLETED	Type 2 Diabetes Mellitus	Vanderbilt University	2015-12	PHASE4
NCT03051282	Active not recruiting	Healthy Volunteers	University of Michigan	2017-04-01	Phase 4
NCT02654678	Unknown status	Heart Failure\|Dilated Cardiomyopathy\|Congenital Heart Disease	Ethicare GmbH	2016-03	Phase 2\|Phase 3
NCT02652728	Unknown status	Heart Failure\|Dilated Cardiomyopathy	Ethicare GmbH	2016-01	Phase 2\|Phase 3
NCT02652741	Unknown status	Heart Failure\|Congenital Heart Disease	Ethicare GmbH	2016-01	Phase 2\|Phase 3
NCT01413542	COMPLETED	Hypertension; Diabetes Type 2	Vanderbilt University	2011-11
NCT00741156	COMPLETED	Hypertension; Congestive Cardiomyopathy	The Hospital for Sick Children	2008-07	PHASE3
NCT00248807	COMPLETED	Orthostatic Hypotension; Spinal Cord Injuries	VA Office of Research and Development	2005-10
NCT00226096	COMPLETED	CVA (Cerebrovascular Accident); Cerebral Hemorrhage; Intracranial Hemorrhages	The George Institute	2005-11

(data from https://clinicaltrials.gov, updated on 2025-02-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enalaprilat dihydrate functions as a potent dicarboxylate-containing inhibitor of angiotensin-converting enzyme (ACE), binding to the active site to block the conversion of angiotensin I to the potent vasoconstrictor angiotensin II while preventing bradykinin degradation. This biochemical inhibition decreases systemic vascular resistance and reduces aldosterone secretion, mitigating vasoconstriction and fluid retention to provide clinical efficacy in managing hypertension, heart failure, and dilated cardiomyopathy.

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>).