CAMBRIDGE, Mass. — Enveric Biosciences has begun investigational new drug-enabling genotoxicity studies for EB-003, its lead neuroplastogen candidate for psychiatric and neurological disorders.
The Cambridge-based biotechnology company said the Good Laboratory Practice studies are designed to evaluate whether EB-003 has the potential to interact with DNA or cause genetic mutations, a key safety assessment required for an IND submission.
Enveric said the studies will include a standard battery of tests aligned with International Council for Harmonisation S2(R1) guidelines, including the Bacterial Reverse Mutation Assay, also known as the Ames Test, and the Micronucleus Assay.
“Initiating these genotoxicity studies marks a significant milestone in the development of EB-003,” said Joseph Tucker, Ph.D., CEO of Enveric Biosciences. “With the recent Executive Order signed by the President on April 18, 2026, the landscape has shifted, potentially expediting research for compounds in the psychedelic and neuroplastogen field. Our preclinical studies are pivotal to ensuring we continue to meet the highest standards of safety as we progress towards first-in-human Phase 1 clinical trials.”
Enveric is developing small-molecule neuroplastogenic therapeutics intended to address psychiatric and neurological conditions. The company said the genotoxicity work is part of the preclinical package needed to support advancement of EB-003 toward first-in-human clinical testing.
