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Phase I First-in-Human Study of EB-003 as Lead Drug Candidate from EVM301 Series

Trial Profile

Phase I First-in-Human Study of EB-003 as Lead Drug Candidate from EVM301 Series

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 20 May 2025

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At a glance

  • Drugs EB 003 (Primary)
  • Indications Anxiety disorders; Major depressive disorder
  • Focus Adverse reactions; First in man

Most Recent Events

  • 14 May 2025 According to an Enveric Biosciences media release, the company focus development efforts on the completion of the data package to support filing an Investigational New Drug (IND) application for EB-003, which company aim to submit to the FDA by the end of the first quarter of 2026.
  • 31 Mar 2025 According to an Enveric Biosciences media release, After the completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA), and the filing of the IND, we will be poised to advance EB-003 into Phase 1 clinical trials and towards the goal of capitalizing on the estimated $35 billion future market opportunity for neuroplastogens
  • 14 Nov 2024 According to an Enveric Biosciences media release, EB-003 Investigational New Drug (IND) application, which company anticipates submitting to the U.S. Food and Drug Administration in the second half of 2025.

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