Clinical Trials

Multiple clinical trials evaluate nicotinamide riboside chloride across diverse conditions, including aging, lipemia, smooth muscle dysfunction syndrome, ulcerative colitis, acute severe malnutrition, and inadequate milk production in preterm birth. Spanning Phase 1 through Phase 4 as well as non-phased interventional designs, these studies are sponsored by academic, non-profit, and industry entities such as AbbVie and the University of Pittsburgh. Recruitment statuses across this portfolio vary, encompassing completed, actively recruiting, terminated, and planned trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05561738 TERMINATED
Ulcerative Colitis
University of Pittsburgh
2024-02-28
NCT06919328 RECRUITING
Healthy Aging
Nutraceuticals Research Institute
2024-10-31
NCT04614714 Not yet recruiting
Preterm Birth|Inadequate Milk Production
University of California Davis
2024-12 Phase 2|Phase 3
NCT06333860 Not yet recruiting
Moderate Plaque Psoriasis
AbbVie
2024-05-07 Phase 4
NCT05436106 Not yet recruiting
Psychological Distress|Stigma Social
Emory University|National Institute of Nursing Research (NINR)
2024-04 Not Applicable
NCT06380504 Not yet recruiting
Acute Malnutrition Severe|Malnutrition Child|Wasting
International Food Policy Research Institute|Ethiopian Public Health Association|UNICEF
2024-04-29 Not Applicable
NCT06382688 UNKNOWN
Healthy Aging
Nutraceuticals Research Institute
2023-11-13
NCT06280482 Recruiting
Smooth Muscle Dysfunction Syndrome (SMDS)
The University of Texas Health Science Center Houston
2024-03-06 Phase 1
NCT03501433 COMPLETED
Aging; Lipemia
Iowa State University
2018-02-01

(data from https://clinicaltrials.gov, updated on 2026-08-10)

Check the Nicotinamide Riboside Chloride (NR-Cl) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nicotinamide riboside chloride functions as a metabolic precursor to elevate intracellular nicotinamide adenine dinucleotide (NAD+) levels, which directly activates the NAD+-dependent deacetylases SIRT1 and SIRT3. This enzymatic pathway enhances mitochondrial oxidative metabolism and cellular bioenergetics, mitigating metabolic abnormalities and cellular stress relevant to clinical conditions such as vascular aging, smooth muscle dysfunction, and inflammatory disorders.

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>).

Note: Technical data last updated: Sep 1, 2026.