D-Aspartic acid Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials evaluate interventions across diverse conditions, including Werner syndrome, bronchopulmonary dysplasia, neonatal respiratory distress syndrome, bone density loss, and heart failure with reduced ejection fraction accompanied by hypotension and left ventricular dysfunction. Spanning Phase 2, combined Phase 2/Phase 3, and non-standard phase designs, these actively recruiting and not-yet-recruiting studies are sponsored by commercial entities such as PRG Science & Technology Co. Ltd. alongside major academic institutions including Boston Children's Hospital, Ottawa Heart Institute Research Corporation, and Rigshospitalet Denmark.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05847179	Not yet recruiting	Werner Syndrome	PRG Science & Technology Co. Ltd.	2025-01-01	Phase 2
NCT05777512	Recruiting	Bronchopulmonary Dysplasia	Boston Children''s Hospital\|Beth Israel Deaconess Medical Center	2024-10	Not Applicable
NCT06405555	Not yet recruiting	Heart Failure With Reduced Ejection Fraction\|Hypotension\|LV Dysfunction	Ottawa Heart Institute Research Corporation	2024-08-01	Phase 2\|Phase 3
NCT05638568	Not yet recruiting	Surfactant Deficiency Syndrome Neonatal\|Respiratory Distress Syndrome Newborn\|Bronchopulmonary Dysplasia	Rigshospitalet Denmark\|Odense University Hospital\|Aalborg University Hospital\|Aarhus University Hospital\|Holbaek Sygehus	2024-07-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

D-Aspartic acid binds to and activates the N-methyl-D-aspartate receptor, triggering downstream signaling cascades that stimulate testicular steroidogenesis and regulate hormonal secretion. This activation modulates neuroendocrine cell function and systemic endocrine homeostasis, providing biological relevance to cellular signaling pathways implicated in complex organ dysfunctions and degenerative clinical conditions evaluated in clinical trials.

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>).