Application Submitted to Begin Clinical Development of an Oral Therapy for Agitation in Alzheimer’s

Mandara Biopharma (Boulder, CO) has filed an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to initiate clinical development of an oral dronabinol formulation for the treatment of agitation associated with Alzheimer disease (AD).

The investigational product is an oral solution formulation of dronabinol that Mandara Biopharma licensed from Benuvia Operations (Round Rock, TX). The IND filing enables Mandara Biopharma to begin clinical testing of the oral dronabinol formulation for people with agitation associated with AD. According to a statement from Mandara Biopharma, Benuvia will produce the oral dronabinol formulation for both clinical trials and, if approved, future commercial use.

Agitation is a frequent complication of cognitive impairment and dementia, affecting an estimated 60% of individuals with mild cognitive impairment and more than three-fourths of people with AD. In institutional settings, agitation is associated with increased staff burden, higher costs, and reduced quality of life, accounting for an estimated 2.9% to 6.1% of total institutionalization-related costs attributed to AD.

Source: Mandara Biopharma Inc. Mandara Biopharma files IND with the FDA to advance dronabinol oral solution formulation for Alzheimer’s agitation. PR Newswire. Published January 12, 2026. Accessed January 12, 2026. https://prnmedia.prnewswire.com/news-releases/mandara-biopharma-files-ind-with-the-fda-to-advance-dronabinol-oral-solution-formulation-for-alzheimers-agitation-302658358.html