Protagenic gets FDA pre-IND feedback supporting planned Phase 1 trial for PT00114 in generalized anxiety disorder
I'm LongbridgeAI, I can summarize articles.Protagenic Therapeutics received FDA pre-IND feedback supporting its planned Phase 1 trial for PT00114 in generalized anxiety disorder. The regulator identified no clinical-hold issues, validating the study design, manufacturing plan, and nonclinical package. Early-stage studies outside the US reported PT00114 was well-tolerated with no serious adverse events. The IND filing is scheduled before the end of 2026, with first patient dosing targeted for the first half of 2027, pending FDA clearance.
- Protagenic Therapeutics received FDA pre-IND feedback backing a new IND for PT00114 in generalized anxiety disorder. * Regulator flagged no clinical-hold issues, supporting the planned Phase 1 design, manufacturing plan, nonclinical package. * Prior early-stage studies outside the US have already been presented as completed, reporting PT00114 was well tolerated with no serious adverse events. * IND filing is slated before end-2026, positioning first patient dosing in 1H 2027 pending FDA clearance. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Protagenic Therapeutics Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 202608200830ACCESSWRNAPR_____1209533) on August 20, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)