Benuvia Operations Supports FDA IND Filing by Mandara Biopharma for Dronabinol Oral Solution in Alzheimer’s Agitation
ROUND ROCK, Texas and BOULDER, Colorado., January 12, 2026 – Benuvia Operations, LLC (Benuvia), a U.S.-based pharmaceutical development and manufacturing company specializing in regulated and controlled-substance drug products and active pharmaceutical ingredients (APIs), today announced its role as manufacturing partner supporting Mandara Biopharma Inc.’s (Mandara) filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate clinical development of a dronabinol oral solution formulation for the treatment of agitation associated with Alzheimer’s disease.
The dronabinol oral solution formulation was developed by Benuvia and licensed to Mandara under an exclusive agreement. Under the collaboration, 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. Approximately 60% of individuals with mild cognitive impairment and 76% of patients with Alzheimer’s dementia experience agitation symptoms. In institutional settings, agitation is a significant driver of increased costs and staff workload, 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.
“This IND filing underscores Benuvia’s ability to support complex, highly regulated drug programs from formulation development through clinical and commercial manufacturing,” said Terry Novak, CEO of Benuvia Operations. “We have deep expertise in the GMP manufacturing of controlled-substance therapies, including cannabinoid-based products, and we are pleased to support Mandara as this program advances into clinical development.”
Under the exclusive license agreement, Mandara holds the rights to develop, study, market, and commercialize the dronabinol oral solution formulation for agitation associated with Alzheimer’s disease, subject to FDA approval. If successful, the program has the potential to become the first FDA-approved synthetic THC prescription therapy specifically indicated for this condition.
“Benuvia’s experience with controlled-substance formulation and manufacturing has been instrumental in enabling this IND submission,” said David Hurley, CEO of Mandara Biopharma. “We value Benuvia as a long-term manufacturing partner as we advance this program toward clinical evaluation for patients with Alzheimer’s disease and their caregivers.”
About Benuvia Operations, LLC
Benuvia Operations, LLC is a U.S.-based pharmaceutical development and manufacturing company specializing in regulated and controlled-substance drug products and APIs. Headquartered in Round Rock, Texas, the company provides end-to-end capabilities spanning formulation and process development, analytical services, regulatory support, and GMP manufacturing. Benuvia supports pharmaceutical and biotechnology partners developing complex small-molecule therapeutics, with particular expertise in cannabinoids, CNS compounds, and other highly regulated molecules. Learn more at www.benuvia.com.
About Mandara Biopharma Inc.
Mandara Biopharma Inc. is a privately held U.S.-based biopharmaceutical company headquartered in Boulder, Colorado, focused on the development of novel therapies for central nervous system (CNS) diseases. Its pipeline includes programs targeting Alzheimer’s agitation, traumatic brain injury, and post-traumatic stress disorder.
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 terms and phrases may be used to identify forward-looking statements. Actual results may differ materially due to risks and uncertainties beyond the companies’ control. These forward-looking statements are based on information currently available, and the companies assume no obligation to update such statements except as required by applicable law.
Contacts
For Benuvia Operations, LLC:
Arijan Limani, Business Development
alimani@benuvia.com
(319) 444-0090
For Mandara Biopharma Inc.:
David Hurley, CEO
dhurley@mandara.co
(808) 497-7771