Oragenics Signs U.S. Manufacturing Deal With Sterling Pharma, Secures GMP Supply For ONP-002 Concussion Drug

Oragenics, Inc., a clinical-stage biotech focused on intranasal treatments for brain-related disorders, has signed a manufacturing agreement with Sterling Pharma Solutions. Under the deal, Sterling will provide cGMP-compliant manufacturing of Oragenics’ lead candidate, ONP-002, an intranasal therapy being developed for the treatment of concussion.

“We are pleased to be partnering with Oragenics for the GMP production of its lead molecule for clinical trials. Our scientific expertise in CNS therapies and our ability to meet critical timelines will support the continued path to market for this transformative drug candidate,” said Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions.

This collaboration ensures that Oragenics will have a reliable, U.S.-based drug supply ahead of its planned Phase IIb clinical trial, expected to begin next year. The trial will assess the early efficacy of ONP-002 in patients with mild traumatic brain injury (mTBI). The agreement is a key operational milestone for Oragenics, reflecting progress in both clinical development and regulatory readiness.

“We are excited to partner with Sterling’s facility in Cary, North Carolina, to support the production of ONP-002. This partnership is a critical milestone in our path forward for Phase IIb clinical trials.  This partnership reinforces our commitment to quality, efficiency, and U.S.-based innovation, and we believe this step will help streamline our clinical development strategy,” said Janet Huffman, Chief Executive Officer of Oragenics. 

ONP-002 aims to address a major gap in brain injury treatment, as there are currently no FDA-approved drug therapies for concussion. The Sterling partnership supports Oragenics’ broader strategy to deliver fast-acting, scalable solutions for neurological trauma, with domestic manufacturing positioning the company for long-term agility and compliance.