Dr. Goodenowe Dietary Therapeutics LLC Announces FDA-Governed Development Pathway For Nutrient-Based Compounds

(MENAFN- EIN Presswire) EINPresswire / -- Dr. Goodenowe Dietary Therapeutics LLC, a U.S.-based company formed to advance selected dietary nutrients and dietary supplement compounds through the FDA regulatory process, today announced plans to pursue FDA regulatory approval of an investigational drug candidate derived from plasmalogen precursor compounds, currently referred to as ProdromeNeuroTM, for the potential treatment of Alzheimer's disease and related dementias.

No drug product has been approved, and no therapeutic claims are being made.

Under current U.S. law, dietary supplements and drugs are regulated under distinct statutory frameworks. Dietary supplements may not be marketed for the diagnosis, treatment, cure, or prevention of disease without FDA approval.

Dr. Goodenowe Dietary Therapeutics said its mission is to advance qualified nutrient-based compounds through the FDA's drug development framework so they can be clinically evaluated under the regulatory framework applied to drug development.

If approved through the FDA process, such products would be regulated as drugs and labeled in accordance with applicable drug regulations.

Dr. Dayan Goodenowe, a neuroscientist and author of“Breaking Alzheimer's,” is leading the company's scientific strategy and said,“It is accepted knowledge that diet and lifestyle are key drivers of health and disease. Plasmalogen biochemistry has been the subject of extensive academic and translational research over the past three decades. The formation of Dr. Goodenowe Dietary Therapeutics allows us to advance this research within the FDA's regulated clinical development framework.”

“There are nutrients and dietary compounds that warrant further clinical evaluation under FDA standards,” Goodenowe said.“Our goal is to complete the necessary regulatory studies to determine safety and efficacy in accordance with FDA requirements.”

Dr. Goodenowe Dietary Therapeutics said it is building its program to follow the FDA's established drug development process for any investigational product, including clinical validation and regulated manufacturing standards appropriate for drug development.

The company said it will provide additional updates as regulatory submissions and clinical development plans are finalized.

About Dr. Goodenowe Dietary Therapeutics LLC

Dr. Goodenowe Dietary Therapeutics LLC is a U.S.-based company designed to advance select investigational compounds through an FDA-governed drug development pathway. The company's initial focus is Alzheimer's disease and related dementias, beginning with ProdromeNeuroTM as its first investigational program candidate.

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