Nicotinamide mononucleotide

JACKSONVILLE, Fla., Oct. 2, 2025 /PRNewswire/ -- Renue by Science™, Inc. is pleased to announce a significant victory for the health and wellness community. After nearly three years of advocacy and persistent efforts, the U.S. Food and Drug Administration (FDA) has officially reversed its position and confirmed that Beta (β) Nicotinamide Mononucleotide (NMN) is lawful for use in dietary supplements. This development follows extensive actions by industry advocates and organizations such as the Natural Products Association (NPA), which challenged the FDA's previous stance that NMN was initially investigated as a drug and therefore could not be marketed as a dietary supplement. Through a citizen petition, legal action, and mobilization of industry and consumer support, the NPA demonstrated that NMN has been marketed as a dietary supplement in the US since 2017 and is thus consistent with the definitions under DSHEA. A key factor in this landmark decision was the recognition that NMN is a naturally occurring molecule that the body produces on its own as part of the NAD+ biosynthesis pathway. This fundamental characteristic underscores NMN's appropriate classification as a dietary supplement rather than a pharmaceutical drug. The FDA's acknowledgment affirms that NMN products are compliant with dietary supplement regulations, marking a pivotal moment for supplement companies and consumers alike. Importantly, this decision protects consumers from the substantially increased costs that would have resulted from pharmaceutical monopolization of this natural compound, ensuring continued affordable access to this vital cellular health nutrient. Bryan Nettles, CEO of Renue by Science, shared his thoughts on the victory: "This is a historic day for both the supplement industry and the consumers we serve. The FDA's reversal confirms what we've known all along, that NMN is a safe, effective, and lawful supplement for promoting healthy aging and vitality. This decision protects consumers from inflated pharmaceutical pricing while safeguarding the pathways for future innovation in the supplement industry. We are grateful for the efforts of industry advocates and remain committed to providing innovative, science-backed products that support people's wellness journeys." This regulatory clarity not only ensures continued access to NMN but also sets an important precedent that will protect future innovations in the dietary supplement space. The decision demonstrates that naturally occurring compounds essential to human health belong in the supplement category, where they can be accessed affordably by all who seek to support their cellular health and longevity. As Renue by Science continues to lead with scientifically validated products, this victory reinforces our dedication to transparency, consumer choice, and the ongoing pursuit of health innovation. About Renue by Science Renue By Science is committed to advancing longevity science by making the latest breakthroughs globally accessible. We specialize in developing innovative supplement formulations that enhance rejuvenation and optimize energy production, empowering individuals to not only extend their lifespan but also improve their quality of life. Our mission is to harness research-backed ingredients and integrate them into bioavailable delivery systems that enhance both health span and lifespan. To learn more about Renue by Science products, visit SOURCE Renue By Science WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

WORCESTER, Mass.--(BUSINESS WIRE)--Metro International Biotech, LLC (MetroBiotech), an EdenRoc Sciences company that is developing more effective treatments of age-related diseases, today announced that the first patients in Cohort 1 of its Phase 1a clinical trial of MIB-725 have received their initial doses. MIB-725 is a new, proprietary investigational drug that has been demonstrated in preclinical studies to be a potent NAD precursor or booster. MIB-725 is a new, proprietary investigational drug that has been demonstrated in preclinical studies to be a potent NAD precursor or booster. In this Phase 1a single ascending dose study, the safety, pharmacokinetics, metabolism and effect of MIB-725 on circulating NAD levels will be determined. Later trials will investigate MIB-725’s efficacy in treating chronic kidney disease associated with aging. In the initial four of eight patients to be dosed in the first cohort, no dose-limiting toxicities were observed. Once the remaining patients are dosed in the cohort, subsequent doses will be gradually increased. If this single dose trial is concluded successfully, a follow-on trial with multiple dosing (Phase 1b) will be run at the same site by the investigators. "Commencement of Phase 1 testing of our novel NAD booster is a key step in our vision of developing the potential of a family of NAD precursor compounds optimized for particular therapeutic indications,” said David Livingston, Ph.D., president and chief scientific officer of MetroBiotech. “The current single ascending dose trial of MIB-725 will create our first safety, PK/PD and metabolic database for this unique molecule, and is an important milestone in our company’s clinical development program. We believe this trial will inform the compound expansion stage of our ongoing clinical trials and may allow us to obtain initial evidence of clinical activity as the program continues to advance." About MIB-725 MIB-725 is the second MetroBiotech therapeutic candidate that targets diseases of aging such as kidney disease, neurodegenerative disease, and muscle disorders. A robust Phase 2 clinical program is ongoing for MetroBiotech’s initial investigational drug MIB-626. Both MIB-626 and MIB-725 have shown pharmacological activity in a variety of preclinical models that demonstrated NAD boosting effects, as well as suppression of pancreatitis, acute kidney injury, and rare mitochondrial disease-associated cardiovascular function. These two compounds are differentially used in NAD-elevating pathways in mammals. About Metro International Biotech, LLC MetroBiotech, an EdenRoc Sciences company, is a clinical-stage metabolism company focused on treating diseases of aging such a muscle weakness, kidney diseases, neurodegenerative diseases, and cancer. MetroBiotech is committed to treating such diseases with NAD boosters of high safety that can effectively target different organs. Through intelligent medicinal chemistry design and process development, the company is producing pharmaceutical-grade NAD boosters at the scale required for early- and late-stage clinical testing. The ongoing independent Phase 1 clinical trials of MIB-725, as well as the Phase 2 clinical trials of MIB-626, are all being run under INDs cleared by FDA. MetroBiotech’s commitment to FDA standards for investigational drugs make the company unique in the NAD booster space. Learn more at metrobiotech.com. Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the timing, conduct and results of the Phase 1 clinical trial, statements about microRNAs and their involvement in cancer, and statements concerning the therapeutic potential of MetroBiotech's MIB-725. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risks associated with drug discovery and development; the risk that the results of clinical trials will not be consistent with MetroBiotech's pre-clinical studies or expectations or with results from previous clinical trials; risks associated with the conduct of clinical trials; risks associated with MetroBiotech's financial condition and its need to obtain additional funding to support its business activities, including MetroBiotech's ability to continue as a going concern; risks associated with the timing and outcome of MetroBiotech's planned regulatory submissions; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with MetroBiotech's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; risks of competition from other companies developing products for similar uses; risks associated with MetroBiotech's dependence on third parties; and risks associated with geopolitical events and pandemics, including the COVID-19 coronavirus and military actions. All information in this press release is as of the date of this release; MetroBiotech undertakes no duty to update this information unless required by law. For more information, please contact: Metro International Biotech’s President & CSO David J. Livingston, Ph.D., MBA at info@metrobiotech.com. More information is available at the company’s website: www.metrobiotech.com © METRO INTERNATIONAL BIOTECH, LLC. ALL RIGHTS RESERVED.