New York, New York, USA, August 20, 2026

Protagenic Therapeutics, a clinical-stage biopharmaceutical company developing peptide-based treatments for stress-related neuropsychiatric disorders, has received written feedback from the U.S. Food and Drug Administration (FDA) following a Type B pre-Investigational New Drug (pre-IND) meeting request for its lead investigational candidate PT00114. The FDA raised no objection to the overall design of the planned Phase 1 program, including the proposed dose-escalation approach and safety-review governance. The agency also did not identify deficiencies that would prevent the company from submitting an IND. Protagenic plans to submit the PT00114 IND before the end of 2026 and is targeting first patient dosing in the first half of 2027, subject to FDA review and clearance.

FDA Supports Planned Phase 1 Development Program

The FDA’s written responses provide Protagenic with regulatory feedback supporting the planned U.S. clinical development pathway for PT00114 in generalized anxiety disorder (GAD). According to the company, the agency identified no clinical hold issues and raised no objections to the three-part Phase 1 program. The feedback also covered the proposed dose-escalation strategy and safety-review governance. In addition, the FDA indicated that Protagenic’s proposed potency and comparability strategy, together with its chemistry, manufacturing, and controls (CMC) and nonclinical packages, appeared reasonable to support an IND submission. These elements are important in establishing the quality, manufacturing, and preclinical foundation required before a new investigational medicine can enter a U.S. clinical program.PT00114 has already undergone Phase 1 single ascending dose and multiple ascending dose studies outside the United States. The company reported that the candidate was well tolerated across the dose levels studied and that no serious adverse events were reported. However, these earlier studies involved a limited number of healthy volunteers and were not conducted under a U.S. IND. Protagenic plans to incorporate this previous clinical experience into its proposed U.S. development program while using refined CMC specifications and expanded dose cohorts.

PT00114 Targets Generalized Anxiety Disorder

PT00114 is described as a first-in-class investigational neuropeptide targeting the tene­urin C-terminal associated peptide (TCAP) pathway for stress-related neuropsychiatric disorders. Protagenic’s preclinical research has shown activity in animal models of anxiety, depression, substance use, and post-traumatic stress. The company believes the candidate could offer a different therapeutic approach by acting on the brain’s stress-response system, although this proposed mechanism and therapeutic potential still require confirmation through clinical studies. The development program is focused on generalized anxiety disorder, a common and often chronic condition characterized by persistent and excessive worry that can interfere with daily functioning. According to the information provided by Protagenic, approximately 6.8 million adults in the United States experience GAD in a given year. Existing treatments include SSRIs, SNRIs, and benzodiazepines, but treatment limitations such as delayed onset, incomplete response, and tolerability or dependence concerns continue to create a need for alternative therapeutic approaches.

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IND Submission Planned for Late 2026

Following the FDA feedback, Protagenic intends to submit the PT00114 IND before the end of 2026, with first patient dosing targeted for the first half of 2027, pending FDA review and clearance. The planned development represents the next stage in advancing PT00114 from early clinical experience toward a U.S. clinical program in GAD. Importantly, PT00114 remains an investigational product that has not been approved by the FDA or any other regulatory authority, and its safety and efficacy have not been established. The FDA’s pre-IND feedback therefore represents a significant regulatory milestone for Protagenic, while the planned IND submission and Phase 1 program will determine whether PT00114 can progress further in clinical development. The company has emphasized that the FDA’s advice is non-binding, and additional questions, requests for data, clinical holds, or delays remain possible during the regulatory process.

Source: Protagenic Therapeutics press relese