About
Oragenics, Inc. is a development-stage company dedicated to developing drugs and therapies focused on nasal delivery of pharmaceutical medications in neurology by leveraging cutting-edge intranasal technology and powdered drug formulations to address critical unmet medical needs, with a primary focus on concussions.
Our lead candidate, ONP-002, is a first-in-class neurosteroid delivered via a proprietary intranasal system designed for rapid brain absorption. ONP-002 has demonstrated broad brain biodistribution, reducing inflammation and oxidative stress—key factors in concussion recovery. With the global concussion treatment market projected to reach $8.9 billion by 2027, ONP-002 represents a groundbreaking approach to an urgent unmet medical need.
An estimated 69 million concussions occur worldwide each year, many of which go undiagnosed or untreated. Beyond concussions, emerging research links traumatic brain injuries to long-term neurological conditions, including Alzheimer’s disease, Parkinson’s disease, and Chronic Traumatic Encephalopathy (CTE). Oragenics is committed to advancing innovative therapies that address these growing healthcare challenges.
Mission
Our mission is focused on pioneering neurological health solutions that go beyond symptom management, offering hope and tangible improvements for millions of patients
History
In January 2024, Oragenics successfully acquired Odyssey Health, Inc.’s neurological assets, including a proprietary intranasal drug delivery system and drug candidates for treating mild traumatic brain injury aka concussions.
This was transformative for Oragenics, as it expanded our pipeline into neurology and advanced drug delivery, our current primary focus. The assets included drug candidates for treating mild traumatic brain injury, also known as concussion, and for treating rare Leukodystrophies.
Oragenics originally made scientific breakthroughs in antibiotic research, discovering that the Streptococcus mutans bacterial strain produces MU1140, a lantibiotic belonging to a novel class of peptide-based antibiotics. Lantibiotics, recognized for their potent antimicrobial properties, remain an area of significant scientific interest.
In May 2020, we acquired Noachis Terra, Inc., positioning Oragenics at the forefront of vaccine development. Our research aimed to develop a long-lasting vaccine for SARS-CoV-2 (COVID-19) through a worldwide, non-exclusive intellectual property agreement with the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH).
Subsequently, in March 2021, we entered a material transfer agreement with Biodextris Inc. to incorporate intranasal mucosal adjuvants into our Terra CoV-2 vaccine, enhancing its immunogenicity.
Further advancing our vaccine capabilities, in July 2021, we signed a licensing agreement with the National Research Council of Canada (NRC). This partnership provided Oragenics with a next-generation vaccine platform capable of rapidly generating cell lines for spike protein antigen production, significantly reducing development timelines for emerging SARS-CoV-2 variants.
Today, Oragenics is solely focused on intranasal drug delivery for neurological conditions, with ONP-002 leading the way in concussion treatment. Our strategic acquisitions and scientific innovations continue to drive our mission to address unmet medical needs through cutting-edge drug delivery technologies.
The acquisition in January 2024 provided a proprietary intranasal drug delivery system, enabling the targeted, non-invasive delivery of therapeutics directly to the brain. This platform not only enhances the efficacy and safety of treatments for concussions but also holds potential for broader applications in neurodegenerative diseases, CNS disorders, and other neurological conditions. By leveraging its expertise in advanced drug delivery, Oragenics is positioning itself at the forefront of neurological innovation, addressing critical unmet medical needs through cutting-edge technology.
Building on our momentum, in February 2025, Oragenics announced a strategic partnership with BRAINBox Solutions, a leader in multi-modality diagnostics for traumatic brain injury (TBI). This collaboration seeks to develop the first-ever intranasal therapy for concussions, combining BRAINBox’s AI-driven biomarker diagnostics with Oragenics’ therapeutic candidate, ONP-002. By integrating advanced diagnostic and treatment technologies, the partnership aims to revolutionize concussion care, creating a trigger-to-treat ecosystem that enables early diagnosis, predictive prognosis, and targeted therapy.