Protagenic Therapeutics, Inc. operates as a pharmaceutical company specializing in the development of medicines manufactured from cannabinoid and cannabinoid-like molecules. Protagenic Therapeutics, Inc. was founded in 2004 and is based in Santa Barbara, California.
Protagenic Therapeutics Receives FDA Pre-IND Feedback Supporting New IND for PT00114 in Generalized Anxiety Disorder
Protagenic received written feedback from the FDA regarding its pre-IND meeting request for PT00114, with the agency raising no objections to the planned Phase 1 program design or CMC strategy.
Management confirmed that the IND submission remains on track for the fourth quarter of 2026, with first patient dosing targeted for the first half of 2027.
The favorable response allows the company to carry forward prior ex-U.S. clinical data into its U.S. development program for generalized anxiety disorder.