First human clinical trial on anti-aging compound Mitopure

Results of first human clinical trial on the anti-aging cellular nutrient Mitopure; a proprietary highly pure form of compound Urolithin A.

Mitopure (Urolithin A) softgel pill

First human clinical trial results on the anti-aging compound, Mitopure (a proprietary, highly pure Urolithin A), published by Amazentis and researchers from the EPFL and SIB. Breakthrough translational science of dietary supplementation with Urolithin A, a pomegranate metabolite, on mitochondrial and cellular health in humans published in the journal Nature Metabolism

Amazentis, an innovative life sciences company pioneering scientific breakthroughs in nutrition to manage health conditions linked to aging, announced today a collaborative publication in Nature Metabolism with scientists at the École Polytechnique Fédérale de Lausanne (EPFL) and the Swiss Institute of Bioinformatics (SIB) demonstrating the Company’s lead product, Mitopure, is safe, bioavailable and improves mitochondrial and cellular health in humans.

Mitopure was orally administered in both single and multiple (4 weeks) daily dosing to 60 healthy elderly subjects in a double-blind, randomized, placebo-controlled study. The trial showed that regular Mitopure dosing during 4 weeks is safe, bioavailable, and effective in improving mitochondrial health through upregulation of mitochondrial gene expression localized to the skeletal muscle and by improving systemic plasma acylcarnitines associated with cellular and mitochondrial function.

Roger Fielding, Ph.D., Professor of Medicine and Nutrition and Associate Director of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, commented, “There are currently no effective solutions to treat age-related decline in muscle function other than months of exercise. This is an important first clinical validation that shows Urolithin A could be a promising solution for the management of healthy muscle function during aging.”

“Mitochondrial and cellular health declines with age, making these results a pivotal milestone as we explore the full breadth of benefits Urolithin A offers for managing human health throughout the aging process,” stated Patrick Aebischer, MD, a co-author on the article, EPFL President Emeritus, and Chairman and Co-founder of Amazentis.

“This positive clinical translation of Urolithin A shows its potential to play an important role in advanced nutritional approaches to improve mitochondrial health through mitophagy and biogenesis, and, as a result, cellular health in humans,” added Johan Auwerx, MD, Ph.D., co-author and Professor at the EPFL.

Nestlé Health Science recently announced a global partnership with Amazentis to develop products containing Mitopure to pursue opportunities in consumer healthcare and medical nutrition.

Chris Rinsch, Ph.D., lead author, Co-founder, and CEO of Amazentis, said, “The rigorous clinical science being published in Nature Metabolism is a critical step towards translating our breakthrough scientific discoveries in nutrition into clinically validated consumer health products that address today’s unmet needs for healthy aging.”

The results are being reported in the current issue of Nature Metabolism in an article titled, “The mitophagy activator Urolithin A is safe and induces a molecular signature of improved mitochondrial and cellular health in humans” (DOI: 10.1038/s42255-019-0073-4).

Background on Mitopure

Amazentis’ proprietary lead product candidate is an oral formulation of Mitopure (a proprietary and highly pure Urolithin A). Urolithin A is a microflora-derived metabolite of ellagitannins, a class of compounds found in the pomegranate and other fruits and nuts. Administration of Mitopure leads to improved mitochondrial function by stimulating mitophagy, a process by which aging and damaged mitochondria are cleared from the cell, leading to the growth of healthy mitochondria. Mitophagy declines in cells as we age and the reduction in mitochondrial function in the muscles of the elderly is thought to be one of the main causes of age-related muscle impairment. Previously, Amazentis and the EPFL reported preclinical results in Nature Medicine in an article titled, “Urolithin A induces mitophagy and prolongs lifespan in C. elegans and increases muscle function in rodents” (doi:10.1038/nm.4132).

About Amazentis

Amazentis is an innovative life science company that employs today’s leading research and clinical science to develop the next generation of products targeting mitochondrial health for advanced nutrition. The Company’s proprietary technology, Mitopure, is currently being evaluated in two Phase 2 clinical trials. Amazentis has established an extensive intellectual property portfolio and know-how around Mitopure, enabling the manufacture and development of advanced nutrition products for human applications. For more information on Amazentis, please visit

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These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. References: *Nutrition studies: 500mg Mitopure® have been shown to (1) induce gene expression related to mitochondria function and metabolism and (2) increase the strength of the hamstring leg muscle in measures of knee extension and flexion in overweight 40-65 year olds. Data from two randomized double-blind placebo-controlled human clinical trials. **Nutrition NOURISH Study: 500mg Mitopure® have been shown to deliver at least 6 times higher Urolithin A plasma levels over 24 hours (area under the curve) than 8 ounces (240ml) of pomegranate juice in a randomized human clinical trial.

© 2024
© 2024