Safety Evaluation for Restorin® NMN, a NAD+ Precursor

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 saf...

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Autores principales:	John Turner, Albert Licollari, Emil Mihalcea, Aimin Tan
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	Restorin® NMN nicotinamide mononucleotide NMN 90-days subchronic oral toxicity safety assessment no-observed-adverse-effect-level Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/b096abebc2134e069f7c873af5f1f204
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spelling	oai:doaj.org-article:b096abebc2134e069f7c873af5f1f2042021-11-11T15:24:37ZSafety Evaluation for Restorin® NMN, a NAD+ Precursor1663-981210.3389/fphar.2021.749727https://doaj.org/article/b096abebc2134e069f7c873af5f1f2042021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fphar.2021.749727/fullhttps://doaj.org/toc/1663-9812NAD+ 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.John TurnerAlbert LicollariEmil MihalceaAimin TanFrontiers Media S.A.articleRestorin® NMNnicotinamide mononucleotideNMN90-days subchronic oral toxicitysafety assessmentno-observed-adverse-effect-levelTherapeutics. PharmacologyRM1-950ENFrontiers in Pharmacology, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Restorin® NMN nicotinamide mononucleotide NMN 90-days subchronic oral toxicity safety assessment no-observed-adverse-effect-level Therapeutics. Pharmacology RM1-950
spellingShingle	Restorin® NMN nicotinamide mononucleotide NMN 90-days subchronic oral toxicity safety assessment no-observed-adverse-effect-level Therapeutics. Pharmacology RM1-950 John Turner Albert Licollari Emil Mihalcea Aimin Tan Safety Evaluation for Restorin® NMN, a NAD+ Precursor
description	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.
format	article
author	John Turner Albert Licollari Emil Mihalcea Aimin Tan
author_facet	John Turner Albert Licollari Emil Mihalcea Aimin Tan
author_sort	John Turner
title	Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title_short	Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title_full	Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title_fullStr	Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title_full_unstemmed	Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title_sort	safety evaluation for restorin® nmn, a nad+ precursor
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/b096abebc2134e069f7c873af5f1f204
work_keys_str_mv	AT johnturner safetyevaluationforrestorinnmnanadprecursor AT albertlicollari safetyevaluationforrestorinnmnanadprecursor AT emilmihalcea safetyevaluationforrestorinnmnanadprecursor AT aimintan safetyevaluationforrestorinnmnanadprecursor
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Safety Evaluation for Restorin® NMN, a NAD+ Precursor

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