Protagenic says FDA pre-IND feedback supports PT00114 IND filing for anxiety disorder
PTIX•FDA feedback supports planned PT00114 IND filing
Protagenic said it received FDA pre-IND feedback backing a new U.S. IND filing for PT00114 in generalized anxiety disorder.
- The FDA flagged no clinical hold issues.
- The agency raised no objections to the planned Phase 1 design or dose-escalation approach.
- IND submission is targeted before the end of 2026, with first patient dosing aimed for the first half of 2027, pending FDA clearance.
