Developer · PTIX · United States

Protagenic Therapeutics, Inc.

Clinical-stage biopharmaceutical company headquartered in New York, NY, developing peptide-based therapeutics for stress-related neuropsychiatric disorders, built on teneurin C-terminal associated peptide (TCAP) science licensed exclusively from the University of Toronto (laboratory of scientific founder Dr. David Lovejoy). Lead asset PT00114 (synthetic TCAP-1) has completed ex-US Phase 1 SAD/MAD studies and is headed for a US IND in generalized anxiety disorder; earlier-stage pipeline includes follow-on TCAP-family neuropeptides plus the PHYX-001 (potassium-channel modulator) and PHYX-002 (cannabinoid) preclinical programs. Quoted on OTCQB as PTIX (formerly Nasdaq; a delisting appeal was disclosed in December 2025). The FY2026 10-K discloses going-concern doubt and a 2026 restructuring to a virtual operating model with two full-time employees; William (Bill) Nichols Jr was appointed President on 2026-02-03. Dr. Garo Armen is Executive Chairman; Dr. Maurizio Fava (MGH) designed and leads the Phase I/IIa clinical study as principal investigator.

protagenic.com ↗

1compound
1program
1indication
Phase 1lead asset

Phase distribution

  • Phase 11

Modality

  • Peptide 1

Pipeline (1)

Catalysts · 1 upcoming · 2 reported

  • fourth quarter 2026Anticipated

    PT00114forGeneralized anxiety disorderRegulatory

    US IND submission for PT00114 in generalized anxiety disorder targeted before end of 2026, following FDA Type B pre-IND written responses that identified no clinical-hold issues; first patient dosing targeted 1H 2027.

    source ↗

Recently reported

  • 2025-12-09met

    PT00114forGeneralized anxiety disorderTopline data

    Phase 1 multiple-dose topline: PT00114 well tolerated across all dose ranges; no serious adverse events; all participants completed dosing; adverse events consistent with an injectable peptide (injection-site reactions).

    source ↗

  • 2024-05-22met

    PT00114forGeneralized anxiety disorderTopline data

    Phase 1 single-ascending-dose complete results: zero clinically-relevant adverse events in 30 subjects across five cohorts at subcutaneous doses up to 1,000 micrograms.

    source ↗

Recent activity

  • Aug 20, 2026Phase changePT00114·Generalized anxiety disorderPhase 1FDA Type B pre-IND written responses received for PT00114 in generalized anxiety disorder: no clinical-hold issues identified; no objection to the planned three-part Phase 1 program, dose-escalation approach or safety review governance; potency/comparability strategy and CMC + nonclinical packages deemed reasonable to support an IND. The new IND builds on the completed ex-US SAD/MAD studies (conducted outside the US, not under an IND). IND submission guided Q4 2026; first patient dosing targeted 1H 2027. Note: this is pre-IND feedback only — no IND has been filed or cleared.source ↗
  • Dec 9, 2025ReadoutPT00114·Generalized anxiety disordermetPhase 1 multiple-dose topline: PT00114 well tolerated across all dose ranges; no serious adverse events; all participants completed dosing; adverse events consistent with an injectable peptide (injection-site reactions).source ↗
  • May 22, 2024ReadoutPT00114·Generalized anxiety disordermetPhase 1 single-ascending-dose complete results: zero clinically-relevant adverse events in 30 subjects across five cohorts at subcutaneous doses up to 1,000 micrograms.source ↗
  • Sep 26, 2023Phase changePT00114·Generalized anxiety disorderPhase 1First-in-human Phase I/IIa study of PT00114 commenced (ex-US, no public registry record): planned 56 subjects randomized to subcutaneous PT00114 or placebo — healthy volunteers first, with patient cohorts planned in treatment-resistant depression, PTSD and generalized anxiety disorder; cortisol biomarkers tracked. Designed and led by principal investigator Dr. Maurizio Fava (Massachusetts General Hospital); clinical program managed by CRO Axiom Real-Time Metrics.source ↗

Competitive landscape

Other companies developing against Protagenic Therapeutics, Inc.'s targets or indications.