Protagenic gets FDA pre-IND feedback supporting planned Phase 1 trial for PT00114 in generalized anxiety disorder

Protagenic Therapeutics received FDA pre-IND feedback backing a new IND for PT00114 in generalized anxiety disorder.

The regulator flagged no clinical-hold issues, supporting the planned Phase 1 design, manufacturing plan, and nonclinical package.

Prior early-stage studies outside the US have already been presented as completed, reporting that PT00114 was well tolerated with no serious adverse events.

The IND filing is slated before end-2026, positioning first patient dosing in 1H 2027 pending FDA clearance.