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A Phase 2b study to evaluate the effects of ONP-002 on clinical outcome measures following concussion in U.S

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Trial Profile

A Phase 2b study to evaluate the effects of ONP-002 on clinical outcome measures following concussion in U.S

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 31 Mar 2025

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At a glance

  • Drugs PRV-002 (Primary)
  • Indications Concussion
  • Focus Adverse reactions

    • Most Recent Events

    • 27 Mar 2025 According to an Oragenics Inc media release, initiation of Phase IIb (Part B) is expected in Q1 2026 and topline data expected in Q2 2026. The company anticipates FDA End-of-Phase 2 Meeting in Q3 2026 and FDA Accelerated Approval Filing (if eligible) in Q3 2026.
    • 21 Aug 2024 New trial record
    • 16 Aug 2024 According to an Oragenics Inc media release, the study is with anticipated to start in the fourth quarter of this year.

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