Safety Evaluation for Restorin® NMN, a NAD+ Precursor
Autor: | Emil Mihalcea, Aimin Tan, Albert Licollari, John Turner |
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Rok vydání: | 2021 |
Předmět: |
Pharmacology
medicine.medical_specialty NMN nicotinamide mononucleotide 90-days subchronic oral toxicity safety assessment RM1-950 Body weight Acute toxicity chemistry.chemical_compound Recovery period Restorin® NMN Endocrinology chemistry Internal medicine Nicotinamide riboside Toxicity medicine Dose group Pharmacology (medical) Therapeutics. Pharmacology NAD+ kinase no-observed-adverse-effect-level Nicotinamide mononucleotide Original Research |
Zdroj: | Frontiers in Pharmacology Frontiers in Pharmacology, Vol 12 (2021) |
ISSN: | 1663-9812 |
Popis: | NAD+ is an abundant molecule in the body and vital to all living cells. NAD+ levels decline with age, and this decline correlates with age-related diseases. Therefore, sustaining NAD+ levels offers potential benefits to healthspan and longevity. Here we conducted toxicity studies to evaluate the safety of Restorin® NMN, a high purity form of the direct NAD+ precursor, β-nicotinamide mononucleotide (NMN). Based on the preliminary toxicity study and a 14-days repeated dose toxicity study at a higher dose level exposure, Restorin® NMN was administered orally to Sprague-Dawley rats for 91 days followed by a 14-days recovery period. The oral doses of 500, 1,000, and 2000 mg/kg/day were compared. There were no test item-related findings that could be considered adverse events in animals dosed at 500 mg/kg/day. The findings in the Restorin® NMN high dose group (2000 mg/kg/day) were similar to the reference item (Nicotinamide Riboside Chloride) dosed at 1740 mg/kg/day: reduced body weight, reductions in body weight gains, and diminished food consumption. In conclusion, the No-Observed-Adverse-Effect-Level (NOAEL) for Restorin® NMN is 1,000 mg/kg/day in female rats and 500 mg/kg/day in male rats, and the Low-Observed-Adverse-Effect-Level (LOAEL) for Resotrin® NMN is 2000 mg/kg/day. |
Databáze: | OpenAIRE |
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