Mandara Biopharma

What Mandara Biopharma does

Mandara Biopharma Inc. is a privately held, clinical-stage U.S. biopharmaceutical company headquartered at 2101 Pearl Street, Boulder, Colorado, focused on developing novel therapies for central nervous system (CNS) disorders. The company's lead asset is a dronabinol oral solution formulation — a synthetic THC product — being developed for the treatment of agitation associated with Alzheimer's disease. Mandara holds an exclusive license from Benuvia Operations, LLC, a U.S.-based contract development and manufacturing organization (CDMO) and active pharmaceutical ingredient supplier, to develop, study, market, and commercialize the formulation; Benuvia also serves as Mandara's manufacturing partner for clinical and potential commercial supply, leveraging its cGMP expertise in controlled-substance products.

The business model is an asset-development and licensing approach rather than an in-house discovery platform. Mandara is pre-revenue: no pricing has been disclosed, products are not yet approved or commercialized, and the company has not disclosed any funding rounds in the available data. The pipeline extends the dronabinol modality to Traumatic Brain Injury (scheduled launch 2029) and PTSD (scheduled launch 2030). Upon regulatory approval, distribution is expected to follow traditional pharmaceutical channels serving long-term care facilities, caregivers, and healthcare systems.

The company recently filed an Investigational New Drug (IND) application with the FDA on January 12, 2026, and received FDA approval to initiate clinical trials on February 17, 2026 — positioning the lead program toward a targeted 2027 launch and a potential first-in-class designation as the first FDA-approved synthetic THC prescription therapy specifically indicated for Alzheimer's agitation. Mandara is led by CEO David Hurley, supported by a full C-suite (CCO Biopharmaceuticals, CRO, CPO, CMO, CFO) and an advisory board spanning pharmaceutical, clinical research, assisted living, wellness, and investment expertise. Market sizes cited by the company include $25 billion for Alzheimer's by 2027, $7.3 billion for PTSD, and $2.7 billion for Traumatic Brain Injury.

Name

Mandara Biopharma

Legal name

Mandara Biopharma Inc.

Website

https://mandarabiopharma.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

Mandara Biopharma is a privately held, clinical-stage biopharmaceutical company developing a dronabinol oral solution for Alzheimer's agitation, with an extended CNS pipeline covering traumatic brain injury and PTSD, operating under an exclusive license from Benuvia Operations.

Ownership category

akta.pro rank

Product category

Alzheimer's Disease CNS Therapeutics

NAICS

Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industries

Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

• CNS therapeutics
• Alzheimer's agitation drug
• Dronabinol oral solution
• Clinical-stage biopharmaceuticals
• CNS disorder treatments

Headquarters

HQ city

Boulder

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Marketing channels3 records

Core offering

Mandara Biopharma is developing a dronabinol (synthetic THC) oral solution formulation, in-licensed from Benuvia Operations, for the treatment of agitation associated with Alzheimer's disease (lead program, with FDA clinical trial approval received in February 2026). The company also has pipeline programs targeting Traumatic Brain Injury (planned 2029) and Post-Traumatic Stress Disorder (planned 2030), positioning it as a CNS-focused clinical-stage biopharmaceutical company.

Product overview

Mandara Biopharma is a privately held biopharmaceutical company developing novel therapies for central nervous system (CNS) disorders. The company's lead product is a dronabinol oral solution formulation for Alzheimer's agitation, currently in clinical development following FDA IND filing and clinical trial approval. The broader pipeline includes therapies targeting Traumatic Brain Injury (scheduled 2029) and PTSD (scheduled 2030). The company operates with a licensing and CDMO partnership model, with Benuvia Operations serving as manufacturing partner.

Differentiator

Problem solved

Functional benefit

Products and services

• Dronabinol Oral Solution An oral solution formulation of dronabinol (synthetic THC) being developed for the treatment of agitation associated with Alzheimer's disease (lead indication, with FDA clinical trial approval received February 17, 2026), and planned for pipeline indications in Traumatic Brain Injury and Post-Traumatic Stress Disorder. Mandara holds exclusive license rights to develop, study, market, and commercialize the formulation, with manufacturing support from Benuvia Operations, LLC.

Quantifiable outcome

• 60% of individuals with mild cognitive impairment experience agitation; 76% of patients with Alzheimer's dementia experience agitation symptoms
• +1 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

One partnership is on record.

• Benuvia Operations, LLCcoreOEM/ Whitelabel/ Licensing Partner · 12 January 2026Benuvia Operations, LLC is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) and Active Pharmaceutical Ingredient (API) supplier. Under an exclusive license agreement, Benuvia granted Mandara rights to develop, study, market, and commercialize the dronabinol oral solution formulation for Alzheimer's agitation. Benuvia serves as Mandara's manufacturing partner for clinical and potential commercial supply of the product, leveraging deep expertise in cGMP manufacturing of regulated and controlled-substance products.

Scale indicators5 records

Recent moves4 records

Expansion highlights4 records

Broad incumbents

• Otsuka Pharmaceutical (Lundbeck/Otsuka partnership): Large established pharmaceutical company that co-developed brexpiprazole (Rexulti), which is FDA-approved for agitation associated with Alzheimer's dementia — a direct competitive incumbent to Mandara's dronabinol oral solution.

Direct peers

• Acadia Pharmaceuticals: CNS specialty pharma with FDA-approved pimavanserin (Nuplazid) for Parkinson's disease psychosis and an active program in Alzheimer's agitation, overlapping directly with Mandara's lead indication and long-term care customer base.
• Jazz Pharmaceuticals: Specialty CNS pharmaceutical company with a portfolio including Xywav and other neurology/cannabinoid-related products, making it directly comparable on business model, controlled-substance expertise, and CNS commercial channels.
• Sage Therapeutics: CNS-focused biopharmaceutical company developing novel therapies for CNS disorders including depression and neurology indications, operating a similar clinical-stage specialty pharma business model targeting CNS prescribers.
• Axsome Therapeutics: Clinical-stage CNS specialty pharmaceutical company developing AXS-05 (dextromethorphan-bupropion) and other therapies for Alzheimer's agitation and CNS indications, directly competing with Mandara in the same patient population and prescriber channel.

Emerging players

• Annovis Bio: Clinical-stage biopharmaceutical company developing therapies for neurodegenerative diseases including Alzheimer's and Parkinson's, targeting a similar CNS specialty prescriber channel as Mandara.
• Cassava Sciences: Clinical-stage biopharmaceutical company focused on Alzheimer's disease therapeutics, targeting overlapping patient populations and CNS specialty pharma channels as Mandara's lead Alzheimer's agitation program.
• Neumora Therapeutics: Clinical-stage CNS-focused biopharmaceutical company developing precision neuroscience therapies, comparable on specialty CNS pharma positioning and clinical-stage development profile to Mandara.
• BioXcel Therapeutics: Clinical-stage CNS specialty pharma developing therapies in neuroscience and immuno-oncology, with overlapping CNS clinical development focus and comparable business model targeting CNS specialty prescribers.

Others

• Benuvia Operations, LLC: Mandara's exclusive licensor and CDMO partner for dronabinol oral solution manufacturing, with deep expertise in cGMP controlled-substance products. Directly relevant as the supplier/manufacturer enabling Mandara's entire pipeline.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat2 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/mandarabiopharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Mandara Biopharma