BLOOMINGTON, Minn., Dec. 11, 2025 /PRNewswire/ -- Gerosynth Labs, Inc., a private biotechnology company pioneering novel oncology and cellular-health therapeutics, today announced that the U.S. Food and Drug Administration Center for Veterinary Medicine (CVM) has accepted multiple Investigational New Animal Drug (INAD) files for the company's lead oncology candidates across equine, feline, and canine categories. Each file was additionally granted a Minor Use and Minor Species (MUMS) Animal Health Act designation, the CVM equivalent of Orphan Drug Designation for human drugs, and a waiver. These acceptances represent a major regulatory milestone and accelerate Gerosynth's advancement toward formal clinical evaluation of its next-generation, nature-derived anticancer formulations.
"These INAD acceptances reflect the tremendous momentum behind our science and validate the dedication of our team," said Alisha O'Dell, CEO and Founder of Gerosynth Labs. "We are committed to rigorously progressing these discoveries through the regulatory pathway so we can deliver safe, transformative oncology solutions for the animals who urgently need them."
Built on years of translational research, Gerosynth's investigational candidates utilize proprietary bioactive compounds and novel reaction products designed to modulate cellular communication, target metabolic dysfunction, and selectively impair tumor viability. The formulations have demonstrated promising early outcomes across multiple species, including improvements in tumor resolution, immune function, and overall quality of life.
"Across my early clinical experiences with Gerosynth's investigational formulations, I've observed responses that give me hope we may have better solutions on the horizon," said Dr. Karen Exline, DVM. "The possibility of a low-toxicity, innovative approach that leverages bioactive compounds is incredibly compelling for both practitioners and the animals we serve."
With the INAD files now active, Gerosynth Labs will begin the next phase of regulatory-guided studies, including controlled safety evaluations, dose-response investigations, and multi-site clinical trials conducted in partnership with veterinary oncologists and academic institutions. With these INADs, Gerosynth Labs is also now approved for clinical investigation in client owned animals.
About Gerosynth Labs, Inc.
Gerosynth Labs, Inc. is a privately held biotechnology company dedicated to advancing innovative solutions in oncology and cellular health. Through its proprietary phytochemical research and development platform, the company designs pharmaceutical and nutraceutical formulations that support immune function, longevity, and metabolic resilience. Gerosynth Labs is the parent company of Mytosynth Nutraceuticals, LLC, a life science subsidiary focused on translating biotechnological discoveries into sustainable, science-based products for both human and animal health. The company is headquartered in Bloomington, Minnesota. For more information please visit https://gerosynth.com.
Disclaimer
This press release contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management's plans, objectives, and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, including scientific, business, economic and financial factors, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. Gerosynth Labs, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
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SOURCE Gerosynth Labs, Inc.
