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Microbiota transplant therapy - Gut-Brain Axis Therapeutics

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Drug Profile

Microbiota transplant therapy - Gut-Brain Axis Therapeutics

Latest Information Update: 11 Jan 2026

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At a glance

  • Originator Gut-Brain-Axis Therapeutics
  • Class Behavioural disorder therapies; Probiotics
  • Mechanism of Action Bacteria replacements; Gastrointestinal microbiome modulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Pitt-Hopkins syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Autism spectrum disorder; Gastrointestinal disorders; Pitt-Hopkins syndrome

Most Recent Events

  • 13 Oct 2025 Gut Brain Axis Therapeutics pipeline announces intention to submit BLA to US FDA for Pitt Hopkins syndrome in Q3 of 2026 (Gut Brain Axis Therapeutics pipeline, October 2025)
  • 13 Oct 2025 Gut Brain Axis Therapeutics announces intention to submit NDA to US FDA for Autism Spectrum Disorder (Gut Brain Axis Therapeutics pipeline, October 2025)
  • 13 Oct 2025 Gut Brain Axis Therapeutics announces intention to submit NDA to US FDA for Pitt-Hopkins Syndrome in Q2 of 2026 (Gut Brain Axis Therapeutics pipeline, October 2025)

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