Protagenic says FDA pre-IND feedback supports PT00114 IND filing for anxiety disorder

• Protagenic received FDA pre-IND feedback backing a new US IND filing for PT00114 in generalized anxiety disorder.
• FDA flagged no clinical hold issues. No objections to the planned Phase 1 design or dose-escalation approach.
• IND submission targeted before end-2026. First patient dosing aimed for H1 2027, pending FDA clearance.

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