Oragenics Doses First Patient ONP-002

Oragenics, a clinical-stage biotechnology company, announced the dosing of the first patient in its Phase IIa clinical trial for ONP-002, a lead candidate for treating concussion and mild traumatic brain injury (mTBI). The trial commenced at Mackay Base Hospital in Australia on March 31, 2026, with rapid patient enrollment highlighting the urgent unmet medical need for an FDA-approved pharmacological treatment for mTBI. ONP-002 is an intranasal neurosteroid designed to address the underlying biology of brain injury, aiming to reduce neuroinflammation, oxidative stress, and cerebral edema. Oragenics plans to enroll 40 patients in this randomized, placebo-controlled study and expects to submit an investigational new drug application to the United States — Food and Drug Administration in Q4 2026 for subsequent U.S. trials. Additional Australian sites, The Alfred Hospital and Royal Adelaide Hospital, are also progressing towards activation.