Protagenic Receives FDA Pre-IND Feedback for Neuropeptide in GAD - BioTuesdays

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

FDA raises no objection to the Company's planned Phase 1 program design, dose-escalation approach, or CMC and nonclinical packages; IND submission remains on track for the fourth quarter of 2026

Protagenic receives FDA pre-IND feedback for neuropeptide in GAD - BioTuesdays

Protagenic Therapeutics (OTCQB: PTIX) has announced that it has received written responses from the FDA to its Type B pre-Investigational New Drug (pre-IND) meeting request for PT00114, the company’s leading investigational neuropeptide product candidate, for the treatment of generalized anxiety disorder (GAD). According to Protagenic, the new IND builds directly on PT00114’s completed Phase 1 single ascending dose and multiple ascending dose st…