Oragenics Inc

Oragenics, Inc. is a development-stage company focused on the research and development of nasal delivery pharmaceutical therapies for neurological conditions and infectious diseases in the United States. Its lead product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid that is lipophilic and can cross the blood-brain barrier. It is intended to reduce swelling, oxidative stress, and inflammation while restoring proper blood flow through gene amplification for the treatment of mild traumatic brain injury. The company was formerly known as Oragen, Inc., was incorporated in 1996, and is headquartered in Lakewood Ranch, Florida.

Biotech & Genomic Medicine▲

Oragenics activates third site for Phase 2a concussion trial, data expected Q4 2026

Oragenics has activated a third site in Australia for its Phase 2a trial of ONP-002, an intranasal neurosteroid for treating mild traumatic brain injury. The Royal Adelaide Hospital received approval on June 29, 2026, joining Mackay Base Hospital and Alfred Health as the third and final site in the trial. The company also submitted a request for a Type B meeting with the U.S. FDA on June 26, 2026 to gain guidance on future clinical development. Data readouts are expected in the fourth quarter of 2026, with an IND submission planned simultaneously. If successful, ONP-002 could become the first FDA-approved therapy for mTBI.

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Biotech & Genomic Medicine

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