D-Alanine Clinical Trials

Size	Price	Qty
500mg	USD 97

Clinical Trials

Multiple Phase 2 and combined Phase 2/Phase 3 clinical trials are currently evaluating therapeutic interventions for Amyotrophic Lateral Sclerosis, Werner Syndrome, Scabies, and Heart Failure with Reduced Ejection Fraction accompanied by hypotension and left ventricular dysfunction. Sponsored by academic medical consortiums, research foundations, and biotechnology companies, these protocols cover neurological, genetic, parasitic, and cardiovascular indications. All of these trials are presently in a not yet recruiting status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05105958	Not yet recruiting	Amyotrophic Lateral Sclerosis	University Hospital Geneva\|University of Lausanne Hospitals\|University of Zurich\|University of Bern\|Cantonal Hospital of St. Gallen	2025-12-01	Phase 2
NCT05847179	Not yet recruiting	Werner Syndrome	PRG Science & Technology Co. Ltd.	2025-01-01	Phase 2
NCT06404333	Not yet recruiting	Scabies	University of Oxford\|Fundação de Medicina Tropical Dr. Heitor Vieira Dourado\|Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)\|University of Basel\|ClinSearch	2024-10-01	Phase 2
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

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

D-Alanine acts as an endogenous co-agonist by binding to the glycine site of the N-methyl-D-aspartate (NMDA) receptor, thereby facilitating receptor activation, promoting intracellular calcium influx, and modulating downstream glutamatergic neurotransmission. This regulation of NMDA receptor signaling maintains neuronal excitability and synaptic function, offering clinical relevance to neurodegenerative conditions such as Amyotrophic Lateral Sclerosis and other systemic disorders 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>).