The beginning
Noah Pharmaceuticals, Inc. is founded and its first patent applications are filed. The combination hypothesis has taken shape in our founder's medical practice, in the care of patients with severe Alzheimer's disease.
PIPELINE & PROGRESS
How far we've come.
Eight years, founder-funded, from a bedside hypothesis to the doorstep of a confirmatory Phase 3.
First patents issue; the program goes formal
The first U.S. patents on the therapeutic approach are granted. In June 2020 the estate goes global through international filings, and in July 2020 Noah's Investigational New Drug application is opened with the U.S. Food and Drug Administration.
First human study of the tablet
The program's first clinical study is completed: a pharmacokinetic (bioavailability) study in healthy adults comparing the fixed-dose combination tablet with its three component medicines taken separately.
The anchor patent issues
A U.S. patent covering the fixed-dose composition and its method of use in Alzheimer's disease is granted, anchoring an estate that now spans 55 issued patents from 65 filings across more than 25 jurisdictions, with protection extending into the late 2030s in the U.S. and to ~2040 in Europe and major Asian markets.
Phase 2 study completed
A randomized, double-blind, placebo-controlled Phase 2 study of the lead candidate in Alzheimer's disease is completed at clinical sites across the United States.
FDA guidance shapes Phase 3
Written feedback from FDA informs the design of a confirmatory Phase 3 study in severe Alzheimer's disease: a randomized, double-blind, placebo-controlled trial of approximately 350 participants, enrolling only severe-stage patients — confirmed at screening by an FDA-cleared blood-based biomarker — and measured with instruments validated for severe disease.
Phase 3 protocol submitted to FDA
The confirmatory Phase 3 protocol is submitted to FDA under the program's open IND — its design shaped by the Agency's written guidance, and its enrollment limited to the severe-stage patients the program was built for.
Confirmatory Phase 3 startup
Startup activities are underway, with clinical trial material manufactured and released. Following completion of the study, the company's regulatory strategy anticipates a New Drug Application under the FDA's 505(b)(2) pathway, which allows a new product to build on the established evidence behind its long-approved components.
PreclinicalPhase 1Phase 2Phase 3
Lead fixed-dose combination
Severe Alzheimer's disease
Phase 3 · in preparation
Lifecycle programs
Additional Alzheimer's stages; other patent-covered neurodegenerative indications
Research
Phase status reflects the company's development plan and is subject to change. The lead candidate is an investigational combination of three medicines, each FDA-approved for other indications; the combination has not been approved for the treatment of Alzheimer's disease, and its safety and efficacy for that use have not been established.