Clinical Trials

Multiple clinical trials, ranging from Early Phase 1 to Phase 4 interventions as well as nutritional studies, are evaluating β-nicotinamide mononucleotide across diverse health conditions. Key targets include metabolic and cardiovascular disorders—such as type 2 diabetes, diabetic kidney disease, and hypertension—alongside sickle cell disease, post-coronary bypass recovery, immune enhancement, tumor prevention, and safety, pharmacokinetics, and performance in healthy volunteers. Sponsored by academic medical centers, biopharmaceutical companies, and institutions such as Brigham and Women's Hospital and Metro International Biotech, these trials encompass completed, recruiting, and not yet recruiting statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07013591 RECRUITING
Coronary Artery Bypass Graft
Brigham and Women's Hospital
 2026-06-10 PHASE2
NCT05878119 COMPLETED
Healthy
Metro International Biotech, LLC
 2023-10-25 PHASE2
NCT05882214 COMPLETED
Binge Drinking; Liver Injury; Nutritional Supplementation; Hepatic Steatosis
Zhejiang Chinese Medical University
 2024-05-01 PHASE1; PHASE2
NCT05984550 UNKNOWN
Enhance Immune Function
Shanghai Cell Therapy Group Co.,Ltd
 2023-08 EARLY_PHASE1
NCT06036355 Not yet recruiting
Postoperative Prevention of Tumor
Shanghai Cell Therapy Group Co.Ltd
 2023-09-30 Early Phase 1
NCT05759468 Recruiting
Type2diabetes|Diabetic Kidney Disease
Brigham and Women''s Hospital|Boston Medical Center
 2023-04-13 Phase 2
NCT05789355 Recruiting
Sickle Cell Disease
LGD|CEN Biotech|Assistance Publique Hopitaux De Marseille|Etablissement Français du Sang
 2023-04-01 Not Applicable
NCT04903210 UNKNOWN
Hypertension
First Affiliated Hospital, Sun Yat-Sen University
 2021-06-01 PHASE4
NCT04910061 Completed
Healthy Volunteers
Seneque SA|Dicentra Inc.|LGD
 2021-08-05 Not Applicable

(data from https://clinicaltrials.gov, updated on 2026-06-26)

Check the β-nicotinamide mononucleotide (NMN) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a vital metabolic precursor, β-nicotinamide mononucleotide is converted by nicotinamide mononucleotide adenylyltransferase into nicotinamide adenine dinucleotide (NAD+), which activates NAD+-dependent enzymes such as sirtuins to restore mitochondrial function and support cellular energy homeostasis. This restoration of bioenergetic capacity and cellular defense mechanisms provides the biological rationale for its clinical investigation in conditions including diabetic kidney disease, cardiovascular dysfunction, and immune system modulation.

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>).

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