Maximize your thought leadership

Oragenics Inc. Advances ONP-002 Toward Phase IIa Concussion Trial with Strategic Q2 2025 Milestones

By Burstable Editorial Team

TL;DR

Oragenics advances ONP-002, aiming to be the first FDA-approved concussion treatment, offering investors a unique opportunity in the growing nasal drug delivery market projected to exceed $40 billion by 2030.

Oragenics secured HREC approval in Australia, appointed Southern Star Research as CRO, and finalized a cGMP agreement with Sterling Pharma Solutions, setting the stage for Phase IIa trials in Q3 2025.

Oragenics' intranasal delivery technology promises a breakthrough in neurological care, potentially improving recovery for concussion patients and paving the way for treatments in neurodegenerative diseases.

Discover how Oragenics' innovative intranasal delivery platform could revolutionize treatment for concussions and beyond, targeting the brain directly to minimize side effects and enhance efficacy.

Found this article helpful?

Share it with your network and spread the knowledge!

Oragenics Inc. Advances ONP-002 Toward Phase IIa Concussion Trial with Strategic Q2 2025 Milestones

Oragenics Inc. (NYSE American: OGEN), a leader in the development of brain-targeted therapeutics through its proprietary intranasal delivery technology, has announced significant advancements in the second quarter of 2025. The company is on track to commence Phase IIa trials for its lead candidate, ONP-002, in the third quarter of 2025, marking a pivotal step toward offering the first FDA-approved pharmacological treatment for concussion.

The company has achieved several key milestones, including securing approval from the Human Research Ethics Committee in Australia, appointing Southern Star Research as its Contract Research Organization (CRO), and finalizing a cGMP manufacturing agreement with Sterling Pharma Solutions in the U.S. These developments underscore Oragenics' commitment to advancing ONP-002 through clinical trials and towards market approval.

Oragenics' innovative intranasal delivery platform represents a breakthrough in drug delivery, enabling rapid and targeted administration of therapeutics directly to the brain. This method bypasses systemic circulation, thereby minimizing side effects and enhancing efficacy. The technology not only holds promise for treating concussions but also has potential applications in addressing acute neurological emergencies and chronic neurodegenerative diseases.

The global nasal drug delivery market, valued for its non-invasive and efficient drug administration capabilities, is projected to surpass $40 billion by 2030. Oragenics' advancements position the company at the forefront of this growing market, with its proprietary technology offering new hope for patients suffering from neurological conditions.

For further details on Oragenics' progress and its pioneering work in neurological care, visit https://ibn.fm/vmS9r. Additional information about Oragenics Inc. and its innovative approaches to brain health can be found at https://ibn.fm/OGEN.

blockchain registration record for this content
Burstable Editorial Team

Burstable Editorial Team

@burstable

Burstable News™ is a hosted solution designed to help businesses build an audience and enhance their AIO and SEO press release strategies by automatically providing fresh, unique, and brand-aligned business news content. It eliminates the overhead of engineering, maintenance, and content creation, offering an easy, no-developer-needed implementation that works on any website. The service focuses on boosting site authority with vertically-aligned stories that are guaranteed unique and compliant with Google's E-E-A-T guidelines to keep your site dynamic and engaging.