Niagen Bioscience, Inc. announced it has entered into a worldwide exclusive commercial license agreement with the Haukeland University Hospital, Bergen, Norway. The agreement secures exclusive rights to a body of proprietary intellectual property, know-how, and data. These data are expected to support future regulatory filings for Conditional Marketing Authorization (CMA), Accelerated Approval (AA), and Marketing Authorization (MA) in the EU under European Medicines Agency (EMA) guidelines for the potential treatment of Parkinson`s Disease (PD) using the Company?s patented nicotinamide riboside (Niagen®) molecule.
With this license, Niagen Bioscience is the only company with the right to seek regulatory approval for a pharmaceutical NR therapy for PD patients. The company retains the right to either commercialize the drug candidate as a potential therapeutic on its own and/or sublicense the program to a strategic pharmaceutical partner to support regulatory advancement and commercialization. Central to this agreement is access to a robust body of scientific data, including findings from the NOPARK trial, the largest and most comprehensive clinical investigation of NAD+ augmentation in persons with early PD to date.
The study was recently completed in June 2025 and is expected to be published by the end of 2025. NOPARK is a randomized, double-blind, placebo-controlled phase III clinical trial featuring 400 individuals with early-stage PD across 12 sites in Norway. Randomized to receive either 500 mg of nicotinamide riboside (Niagen) twice daily or placebo for 52 weeks, participants had follow-up assessments at five time points in a one-year period.
The primary endpoint is the MDS-UPDRS total score, a gold standard measure of PD progression. This agreement builds on a longstanding collaboration between Haukeland University Hospital?s Dr. Charalampos Tzoulis and Niagen Bioscience?s external research program, CERP. The first of several material transfer agreements (MTAs) dates to March 2018.
Since then, independent research supported by CERP has helped catalyze over 300 research collaborations and more than 35 peer-reviewed clinical studies, including four landmark trials assessing the therapeutic potential of Niagen NR for PD: the phase I/IIa NADPARK study, published in Cell Metabolism, the phase I NR-SAFE study published in Nature Communications, the phase IIa N-DOSE (not yet published), and the phase III NOPARK study (not yet published). In connection with this license agreement, the Company also established a wholly owned subsidiary, which represents a pivotal step in Niagen Bioscience?s evolution from supplement science to regulated drug development in pursuit of therapeutics for neurodegenerative diseases with high unmet needs.
