Oragenics (OGEN) FDA Approvals

Oragenics' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Oragenics (OGEN). Over the past two years, Oragenics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ONP-002. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

ONP-002 FDA Regulatory Timeline and Events

ONP-002 is a drug developed by Oragenics for the following indication: To Treat Concussion. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - July 31,2025

Phase 2a

• Drug: ONP-002
• Announced Date: July 31, 2025
• Indication: To Treat Concussion

Oragenics, Inc announced the selection of Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa clinical trial of ONP-002, the company's lead drug candidate for concussion.

Oragenics, Inc. has chosen Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa trial of ONP-002, the company’s lead drug candidate for concussion. This study will test a self-administered, intranasal treatment in adults with mild traumatic brain injury (mTBI).

Southern Star Research is a full-service CRO known for early-phase trials across Australia and the Asia-Pacific region. Their team brings strong site management, regulatory know-how and hands-on operational support to run the randomized, double-blind, placebo-controlled trial. “Partnering with Southern Star ensures we leverage experienced clinical leadership to move ONP-002 forward efficiently,” said Dr. James Kelly, Oragenics’ Chief Medical Officer.

Dr. David Lloyd, Founder and Managing Director of Southern Star Research, added that this Phase IIa study marks a significant milestone. With ethics approval already in hand, both companies are finalizing site selection, investigator agreements and preparing for patient enrollment, which is expected to start soon.

Oragenics chose Australia for its streamlined regulatory process, experienced concussion sites and R&D tax incentives. ONP-002 is a novel intranasal neurosteroid designed to deliver the drug directly to the brain while limiting systemic exposure. The Phase IIa trial will assess safety, tolerability, pharmacokinetics and early pharmacodynamic effects in adults with mTBI.

Approved - May 13,2025

• Drug: ONP-002
• Announced Date: May 13, 2025
• Indication: To Treat Concussion

Oragenics, Inc announced that it has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate its Phase II clinical trial evaluating ONP-002, the Company's proprietary neuroprotective therapy, for the treatment of mild traumatic brain injury (mTBI), aka concussion.

Oragenics, Inc. announced that it has received approval from Australia’s Human Research Ethics Committee (HREC) to start its Phase II clinical trial for ONP-002. This proprietary neuroprotective therapy is aimed at treating mild traumatic brain injury (mTBI), commonly known as concussion. The approval marks a key milestone as the company expands its clinical trials internationally, with patient enrollment in Australia expected to begin as early as the second quarter of 2025.

The trial will be conducted in level 1 trauma emergency departments, where concussed patients, often injured in motor vehicle accidents, falls, or contact sports, receive treatment. The intranasal administration of ONP-002 offers a non-invasive, efficient way to deliver the therapy directly to the brain, potentially improving recovery outcomes for concussion patients. This development represents a significant step toward offering a much-needed therapeutic option for individuals affected by concussions.

Regulatory Update - March 6,2025

• Drug: ONP-002
• Announced Date: March 6, 2025
• Indication: To Treat Concussion

Oragenics, Inc. announced the submission of its Investigator's Brochure (IB) application in preparation for its Phase II clinical trial using ONP-002 in Australia

Oragenics, Inc. recently submitted its Investigator’s Brochure (IB) application as a key step toward launching a Phase II clinical trial in Australia. This submission is focused on using ONP-002, a new intranasal neurosteroid, to treat mild traumatic brain injury (mTBI), commonly known as a concussion. The IB provides detailed information on the drug’s safety, pharmacokinetics, and pharmacodynamics, which will help guide the clinical trial protocols. It outlines essential details such as dosing instructions, administration guidelines, blood biomarker analysis, and safety monitoring. By sharing this comprehensive data with investigators, Oragenics aims to ensure clear communication about the study’s objectives. The next phase will test the feasibility and potential benefits of acute intranasal administration in mTBI patients, moving a step closer to addressing the unmet need for effective concussion therapies.

Provided Update - October 9,2024

• Drug: ONP-002
• Announced Date: October 9, 2024
• Indication: To Treat Concussion

Oragenics, Inc. provided a corporate update reflecting on the company's progress throughout 2024, including key milestones in the development of ONP-002, its lead candidate for the treatment of concussions.

Oragenics, Inc. provided an update on its progress during 2024, highlighting important milestones in the development of its lead drug candidate, ONP-002, for treating concussions. The company has advanced the drug through several key stages by strengthening its clinical team with new expert appointments, which now include a Chief Medical Officer and a Chief Clinical Officer. ONP-002 has successfully passed critical FDA-required tests, such as cardiotoxicity and genotoxicity studies, assuring its safety profile. The company also completed the spray-dry manufacturing process and developed an improved nanoparticle formulation that increases the total drug per dose, which is expected to enhance brain delivery when applied intranasally. Additionally, a strategic partnership with Avance Clinical supports the upcoming Phase II trials aimed at evaluating the efficacy of ONP-002 in reducing concussion symptoms and improving patient recovery. This progress paves the way for further clinical development of the treatment.

Provided Update - October 8,2024

• Drug: ONP-002
• Announced Date: October 8, 2024
• Indication: To Treat Concussion

Oragenics Inc announced that has completed a key study for their new concussion drug, ONP-002.

Oragenics Inc has completed an important study for its new concussion drug, ONP-002. The drug is delivered through the nose, which could allow it to quickly reach the brain after a head injury. In this study, scientists used a method called intranasal casting, where a metal model of the nose is used to see where the drug goes. The results showed that ONP-002 targets key areas in the nose that connect directly to the brain, increasing the likelihood that the medicine is effective in treating concussions. These promising findings have helped the company decide to move forward with Phase II human testing. If successful, the approach could help provide fast treatment for concussion patients, who receive their first dose of the drug within eight hours of injury.

Provided Update - August 21,2024

• Drug: ONP-002
• Announced Date: August 21, 2024
• Indication: To Treat Concussion

Oragenics, Inc. announced the completion of its spray-dried formulation and filling in the nasal device for its lead candidate, ONP-002, for concussion. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity.

Oragenics, Inc. has completed the development of a spray-dried formulation and has filled a novel intranasal device for its lead candidate, ONP-002, aimed at treating concussions. ONP-002 is a new chemical entity designed to work by delivering the drug directly into the brain through the nasal cavity. This powder formulation, loaded into a breath-propelled device, promises fast and efficient brain exposure potentially reducing the negative effects following a concussion. The product is now ready for use in a Phase IIa clinical trial in Australia, where both the active drug and a matching placebo have been prepared. In the trial, concussed patients are expected to receive treatment within 8 hours of the injury, with doses administered twice a day over five days. This innovative approach could become the first pharmaceutical treatment for concussions using a non-invasive, nasal delivery method.

Provided Update - August 16,2024

Phase 2

• Drug: ONP-002
• Announced Date: August 16, 2024
• Target Action Date: Q4 2024
• Estimated Target Date Range: October 1, 2024 - December 31, 2024
• Indication: To Treat Concussion

Oragenics, Inc announced that Phase 2 human trials are being planned with anticipation of starting in the fourth quarter of this year.

Oragenics, Inc. is moving forward with its development of an intranasal pharmaceutical candidate, ONP-002, designed to treat concussion. The company announced that Phase 2 human trials are being planned and are expected to start in the fourth quarter of this year. This new stage will further assess the safety and efficacy of ONP-002 in patients suffering from concussion.

The advancement to Phase 2 trials marks a key step in Oragenics’ mission to develop effective treatments for neurological injuries. With improved drug formulation that enhances delivery to the brain, the trial will help determine how well ONP-002 performs in real-world scenarios, potentially offering a much-needed treatment option for those affected by concussions.

Provided Update - August 16,2024

• Drug: ONP-002
• Announced Date: August 16, 2024
• Indication: To Treat Concussion

Oragenics, Inc announced recent and key 2024 business progress.

Oragenics, Inc. recently announced significant 2024 business progress centered on advancing its lead candidate, ONP-002, for the treatment of concussion. The company demonstrated that ONP-002 is stable across a wide temperature range, removing the need for cold storage and making it suitable for use in challenging environments such as military training and contact sports. In addition, the firm improved the intranasal drug formulation by increasing the dose fourfold, which enhances the amount of drug delivered to the brain with each treatment.

Oragenics is preparing for Phase 2 human trials, with a planned start in the fourth quarter, and has partnered with Avance Clinical in Australia to conduct the study. The company also finalized a prototype for an automated intranasal device to aid in administering the treatment during the acute phase of injury. Additionally, a public offering raised approximately $1.1 million and top medical experts have been appointed to lead upcoming clinical efforts.

Provided Update - August 14,2024

• Drug: ONP-002
• Announced Date: August 14, 2024
• Indication: To Treat Concussion

Oragenics, Inc. announced its lead candidate for treating concussion, ONP-002, is stable across a wide temperature range, eliminating the need for cumbersome cold storage for the drug device combination.

Oragenics, Inc. announced that its lead candidate for treating concussion, ONP-002, is stable across a wide range of temperatures. The stability of ONP-002, which remains over 99% pure for up to 3 months at temperatures from -20°C to 104°C, means it does not need cold storage. This breakthrough is important because cold chain storage can be difficult and impractical, especially during transport and in field conditions such as sports events and military operations. The drug is designed as a spray-dried powder delivered intranasally through a breath-propelled system, which helps it quickly reach the brain. This feature is crucial for treating concussions immediately and reducing long-term complications. The innovation could provide a much-needed treatment option for concussions, a condition affecting millions of people globally each year.

Provided Update - August 12,2024

• Drug: ONP-002
• Announced Date: August 12, 2024
• Indication: To Treat Concussion

Oragenics, Inc. announced its lead candidate for treating concussion, ONP-002, successfully completed a study that indicates it does not cause DNA damage and genotoxicity in an animal model.

Oragenics, Inc. announced that its lead concussion treatment candidate, ONP-002, has successfully completed an animal study showing it does not cause DNA damage or genotoxicity. The study was conducted under Good Laboratory Practice conditions, where multiple doses of ONP-002 were administered and the animal bone marrow was analyzed for genetic mutations and signs of disrupted cell division. The results indicated no cancer-causing DNA damage, suggesting that the drug does not interfere with the cell cycle. This finding is important because the FDA requires thorough preclinical testing to ensure that a pharmaceutical does not induce harmful genetic changes before it can proceed to clinical trials. Encouraged by these safety results, Oragenics plans to move forward with a Phase II clinical trial to further assess ONP-002 as a potential safe treatment for concussion patients.

Provided Update - August 8,2024

• Drug: ONP-002
• Announced Date: August 8, 2024
• Indication: To Treat Concussion

Oragenics, Inc. announced its lead candidate for treating concussion successfully completed a study that indicates ONP-002 does not cause cardiotoxicity.

Oragenics, Inc. announced that its lead candidate for treating concussions, ONP-002, successfully completed a study demonstrating it does not cause cardiotoxicity. The study was conducted under Good Laboratory Practices with Charles River Laboratories and focused on evaluating the drug’s effects on hERG ion channels. Researchers found that the inhibitory concentrations were greater than 10 micromolar, suggesting a wide cardiac safety margin.

This positive safety data, based on Phase I clinical trial dosing and blood plasma concentrations, indicates that ONP-002 is unlikely to trigger cardiac arrhythmia. With these promising results, Oragenics is now planning Phase II trials to further assess the drug’s effectiveness in treating concussions, a condition with significant healthcare impacts worldwide.

Provided Update - July 10,2024

• Drug: ONP-002
• Announced Date: July 10, 2024
• Indication: To Treat Concussion

Oragenics, Inc announced it has developed a new formulation for its novel neurosteroid. Oragenics' lead drug candidate for concussion, ONP-002, is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain.

Oragenics, Inc. announced they have developed a new formulation for their novel neurosteroid, which is a key step in improving concussion treatment. Their lead drug candidate, ONP-002, is a new chemical entity designed to be delivered through the nasal cavity to reach the brain quickly. The company believes that this method allows the drug to enter the brain in minutes, potentially reducing the short-term symptoms of a concussion and preventing long-lasting issues.

This improved formulation offers higher final dose levels and better intranasal drug adhesion, which helps the drug absorb for a longer time. By increasing bioavailability, ONP-002 may offer enhanced protection for the brain during the critical period following a concussion. Oragenics is planning a Phase II study to assess the safety and effectiveness of this novel intranasal approach in concussed patients.