Protagenic Therapeutics Receives FDA Pre-IND Feedback Supporting New IND for PT00114 in Generalized Anxiety Disorder

The FDA raised no objection to the company’s planned Phase 1 program design, including the dose-escalation approach and CMC/nonclinical packages. The company stated its IND submission remains on track for Q4 2026, reducing regulatory execution risk and supporting the program’s timeline.

Analysis

The FDA raised no objection to the company’s planned Phase 1 program design, including the dose-escalation approach and CMC/nonclinical packages. The company stated its IND submission remains on track for Q4 2026, reducing regulatory execution risk and supporting the program’s timeline.