NADH Disodium Salt Hydrate Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Several clinical trials are evaluating the utility and metabolic influence of NADH-related interventions across conditions such as chronic obstructive pulmonary disease compared to healthy controls, peripheral blood immune cell function, and liver transplant failure prevention. Spanning Early Phase 1 to observational designs, these protocols are supported by academic medical centers, regional health authorities, biotechnology entities, and international research foundations, with recruitment statuses currently ranging from recruiting to not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06068322	Recruiting	COPD\|Healthy Controls	Umeå University\|Hasselt University\|Swedish Heart Lung Foundation\|European Research Council\|The Swedish Research Council\|Strategic Research Area Health Care Science (SFO-V)\|Ziekenhuis Oost-Limburg	2023-11-09	Not Applicable
NCT05984550	Not yet recruiting	Enhance Immune Function	Shanghai Cell Therapy Group Co.Ltd\|Shanghai Mengchao Cancer Hospital	2023-08	Early Phase 1
NCT05361044	Recruiting	Liver Transplant Failure	Hospices Civils de Lyon	2022-08-22	Not Applicable

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

Check the NADH Disodium Salt Hydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

NADH functions as an essential coenzyme and regenerating electron donor in central catabolic pathways, driving mitochondrial oxidative phosphorylation through glycolysis, fatty acid oxidation, and the citric acid cycle to sustain intracellular energy balance. By maintaining redox homeostasis and bioenergetic output, NADH restoration supports cellular survival and functional integrity, which is directly relevant to mitigating metabolic exhaustion in chronic obstructive pulmonary disease, enhancing immune cell rejuvenation, and preserving tissue viability during liver transplantation.

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>).