Isosorbide Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials evaluate isosorbide across diverse therapeutic applications, including heart failure, recurrent pregnancy loss, tourniquet-associated hypertension, Fontan physiology, isolated oligohydramnios, and prolonged pregnancy. Spanning Early Phase 1 through Phase 3 evaluations alongside unassigned classifications, these investigations are sponsored by academic institutions, university hospitals, and research consortia such as Al-Azhar University, Assistance Publique - Hôpitaux de Paris, Benha University, Children's Hospital Medical Center Cincinnati, and the National Heart, Lung, and Blood Institute. The trial portfolio includes completed studies, trials that are not yet recruiting, and entries with unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05954689	Not yet recruiting	Tourniquets\|Anesthesia Conduction\|Anesthetics Local\|Hypertension	Hospital da Luz Portugal	2023-07-10	Not Applicable
NCT05341856	Unknown status	Recurrent Pregnancy Loss	Al-Azhar University	2022-05-01	Early Phase 1
NCT04297241	Completed	Fontan	Children''s Hospital Medical Center Cincinnati	2019-12-12	Phase 2
NCT02053493	Completed	Heart Failure	Adrian Hernandez\|National Heart Lung and Blood Institute (NHLBI)\|Mayo Clinic\|University of Vermont\|Duke University	2014-04	Phase 2
NCT02712125	Completed	Isolated (Idiopathic) Oligohydramnios	Benha University	2013-08	Phase 2\|Phase 3
NCT00930618	Completed	Prolonged Pregnancy\|Nulliparity	Assistance Publique - Hôpitaux de Paris	2009-06	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an osmotic agent, isosorbide elevates the solute concentration and osmotic pressure within the lumen of renal tubules, thereby inhibiting the passive reabsorption of water and electrolytes across renal epithelial cells. The resulting osmotic diuresis decreases intravascular volume and reduces vascular preload, providing a clear biological mechanism supporting its clinical evaluation in cardiovascular conditions such as heart failure and hypertension.

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>).