Mandara Biopharma Files IND with the FDA to Advance Dronabinol Oral Solution Formulation for Alzheimer's Agitation

BOULDER, Colo., Jan. 12, 2026 /PRNewswire/ -- Mandara Biopharma Inc., a privately held U.S.-based biopharmaceutical company focused on novel therapies for central nervous system (CNS) disorders, today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate clinical development of its dronabinol oral solution formulation for the treatment of agitation associated with Alzheimer's disease.

Mandara's dronabinol oral solution formulation was licensed from Benuvia Operations, LLC ("Benuvia"), a U.S.-based global Contract Development and Manufacturing Organization (CDMO) and Active Pharmaceutical Ingredient (API) supplier servicing pharmaceutical and biotech companies. Under the agreement, Benuvia will serve as Mandara's manufacturing partner for the clinical and potential commercial supply of the product.

Agitation is one of the most challenging and burdensome symptoms associated with Alzheimer's disease, placing significant emotional, physical, and financial strain on caregivers, long-term care facilities, and healthcare systems. Agitation is common in Alzheimer's disease, with approximately 60% of individuals with mild cognitive impairment and 76% of patients with Alzheimer's dementia experiencing symptoms.¹ In institutional settings, agitation is a major driver of increased costs, staff workload, and diminished quality of life, accounting for an estimated 2.9% to 6.1% of total institutionalization costs related to Alzheimer's disease, which were estimated at $84.1 billion in 2018.²

"Filing this IND is an important milestone for Mandara as we advance a potential new therapeutic option for one of the most difficult aspects of caring for patients with Alzheimer's disease," said David Hurley, CEO of Mandara Biopharma. "Our goal is to bring forward a rigorously studied, FDA-approved treatment that can meaningfully improve outcomes for patients, caregivers, and care facilities. If successful, this program has the potential to become the first FDA-approved synthetic THC prescription therapy specifically indicated for agitation associated with Alzheimer's disease."

Under the exclusive license agreement, Mandara Biopharma holds the rights to develop, study, market, and commercialize its dronabinol oral solution formulation for Alzheimer's agitation, subject to FDA approval.

"We are pleased to support Mandara Biopharma's clinical development program by manufacturing and supplying this dronabinol oral solution formulation," said Terry Novak, CEO of Benuvia. "Benuvia has deep expertise in the development and cGMP manufacturing of regulated and controlled-substance products, and we look forward to continuing our collaboration as this program advances."

About Mandara Biopharma Inc.
Mandara Biopharma Inc. is a privately held U.S.-based biopharmaceutical company focused on novel therapies to treat CNS diseases. Their product pipeline includes new therapies for Alzheimer's Agitation (2027 scheduled launch), Traumatic Brain Injury (2029) and PTSD (2030). Learn more at www.mandarabiopharma.com.

Forward-Looking Statements
This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions may identify forward-looking statements. Actual results may differ materially due to risks and uncertainties beyond the companies' control. These statements are based on information currently available, and the companies assume no obligation to update such statements except as required by applicable law.

Contact:
David Hurley
CEO, Mandara Biopharma
[email protected]
808-497-7771

¹ Lim MM, Gerstner JR, Holtzman DM. The sleep-wake cycle and Alzheimer's disease: What do we know? Neurodegenerative Disease Management 2014; 4(5): 351-362
² Cloutier, M, et al. Institutionalization risk and costs associated with agitation in Alzheimer's disease, Alzheimer's and Dementia: Translational Research and Clinical Interventions 5 (2019, 851-861)

SOURCE Mandara Biopharma Inc.