OUR SCIENCE
A multi-pathway approach to a multi-process disease.
Decades of single-target drug development in Alzheimer's have produced hard lessons. The field's understanding has shifted: Alzheimer's disease involves multiple interacting biological processes, and there is growing scientific consensus that combination approaches deserve serious study. Noah Pharmaceuticals was built on that premise.
Our lead investigational candidate
Our lead program is a once-daily oral fixed-dose combination of three medicines, each FDA-approved for other indications, in development for severe Alzheimer's disease:
A tetracycline-class agent
Studied for its anti-inflammatory and neuroprotective properties.
A statin
Studied for its effects on cholesterol and lipid pathways implicated in Alzheimer's biology.
An mTOR inhibitor
Studied for its role in autophagy — the cellular clearance machinery that declines with age.
The composition and its use in Alzheimer's disease are protected by a U.S. anchor patent issued in 2024, with counterpart grants across Europe (validated in 38 states), Japan, South Korea, Mexico, Indonesia, Malaysia, Singapore, and Nigeria — 55 issued patents from 65 filings across more than 25 jurisdictions in all.
Why combination, why now
The biology argues for it.
Neuroinflammation, disordered lipid metabolism, and failing cellular clearance are each independently implicated in Alzheimer's progression. A therapy that engages one pathway leaves the others untouched.
The tools finally exist.
In 2025, the FDA cleared the first blood test to aid the diagnosis of Alzheimer's disease. Confirming pathology now takes a blood draw rather than a PET scan or a lumbar puncture — changing what is possible in trial enrollment and, eventually, in clinical practice.
The pathway is established.
Because every component is a long-approved medicine, the program advances under the FDA's 505(b)(2) regulatory pathway, which allows a new product to build on existing evidence about its components.
OUR ORIGIN
Science that started at the bedside
Noah Pharmaceuticals began in clinical practice. Our founder, a physician with more than four decades in clinical medicine, developed the combination hypothesis while caring for patients with severe Alzheimer's disease — and then did what physicians-turned-founders must do: subjected it to formal science. He founded the company in 2018, filed the patents, opened an Investigational New Drug application with the FDA in 2020, took the combination through its first human pharmacokinetic study, and advanced the program into a randomized, double-blind, placebo-controlled Phase 2 — completed in 2025. Every step, founder-funded.
Our lead candidate combines three medicines, each individually FDA-approved for other indications. The combination is investigational: it has not been approved by the FDA or any other regulatory authority for the treatment of Alzheimer's disease, and its safety and efficacy for that use have not been established.