About Dr. Goodenowe Dietary Therapeutics

On February 1, 2026, all rights to ProdromeNeuro™ were licensed to Dr. Goodenowe Dietary Therapeutics LLC (DGDT). Under this agreement, DGDT is advancing ProdromeNeuro™ through the FDA approval process for the investigation of Alzheimer’s disease and other neurodegenerative conditions. ProdromeNeuro™ is not currently available as a commercial therapeutic.

DGDT was established to address a significant gap in therapeutic development: rigorously validated, dietary-derived therapeutics for neurodegenerative diseases.

The Dietary Therapeutic Approach

Epidemiological, observational, and interventional research consistently identifies diet and lifestyle as major contributors to chronic disease. Deficiencies in essential nutrients, whether due to environmental availability or genetic variation in metabolic pathways, contribute to dysfunction in cellular systems, which can manifest as disease.

While dietary supplements have been used to address these deficiencies, their development has largely been limited to structure-function claims. Disease-specific efficacy data require clinical trial infrastructure and regulatory pathways typically reserved for pharmaceuticals.

The Regulatory and Economic Reality
 
The Dietary Supplement Health and Education Act of 1994 (DSHEA) established a regulatory framework under which supplements are regulated as foods rather than drugs. Under DSHEA, manufacturers may make structure and function claims, but are prohibited from making disease treatment or prevention claims without FDA approval as a drug.
 
Few supplement manufacturers pursue formal drug approval due to:
 
  • Clinical trial costs typically range from tens to hundreds of millions of dollars
  • FDA application review fees of $4,682,003 (2026)

  • Annual prescription drug fees of $442,213

  • Unlike man-made drug molecules, naturally occurring dietary supplements are not eligible for patent protection. As a result, a supplement manufacturer completing the FDA approval process would face ongoing regulatory costs exceeding $400,000 annually without market exclusivity, while similar products remain available as unregulated supplements.
This economic structure has created a significant evidence gap: consumers lack access to rigorously controlled clinical data on dietary supplements for the treatment or prevention of disease.

Dr. Goodenowe Dietary Therapeutics Solution

DGDT was formed to generate drug-level evidence for plasmalogen-based therapeutics. Using ProdromeNeuro™ as the lead candidate, our company is conducting rigorous clinical studies designed to meet FDA standards for safety and efficacy in Alzheimer’s disease and related conditions.

This approach combines:

  • A well-defined biological target: investigating the restoration of plasmalogen levels in the brain
  • Compounds that the body can absorb and convert into plasmalogens
  • Clinical trial facilities designed to generate FDA-quality evidence

ProdromeNeuro™ Transition
Dr. Dayan Goodenowe, Ph.D., is the founder of DGDT and the inventor of ProdromeNeuro™. Dr. Goodenowe is also the founder of Prodrome Science, a separate entity that markets plasmalogen-based dietary supplements.
On February 1, 2026, all rights to ProdromeNeuro™ were licensed to DGDT for development exclusively through FDA drug approval pathways. During the transition period, ProdromeNeuro™ remains available as a dietary supplement in limited quantities through Prodrome Science. The dietary supplement version of ProdromeNeuro™ is regulated under the Dietary Supplement Health and Education Act (DSHEA) and is not the same as the investigational drug candidate described on this website.