Oragenics, Inc. announced on July 16, 2025, that it entered into a manufacturing agreement with Sterling Pharma Solutions. This agreement is for the Good Manufacturing Practice (GMP) production of its lead drug candidate, ONP-002, for concussion treatment.
This partnership is expected to ensure a compliant drug product supply ahead of the planned Phase IIb clinical trials, which the company expects to start next year. The collaboration secures domestic production capabilities to support upcoming clinical and regulatory efforts.
CEO Janet Huffman stated that this partnership is a critical milestone for Phase IIb clinical trials, reinforcing the company's commitment to quality, efficiency, and U.S.-based innovation. This step is expected to streamline the clinical development strategy for ONP-002.
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