New Phase 1 Data on DLX-001 for Patients With Major Depressive Disorder

Author(s):

Key Takeaways

DLX-001 showed a generally safe and well-tolerated profile in a phase 1 study with 106 healthy volunteers.
No psychotomimetic, hallucinatory, or dissociative effects were observed, differentiating DLX-001 from classic psychedelics.
Preliminary brain effects suggest potential for future studies in patients with major depressive disorder.

DLX-001 is a novel neuroplastogen under development for the treatment of major depressive disorder. Learn more about the latest phase 1 data here.

Aaron Koenig, MD, the chief medical officer of Delix Therapeutics, shares more on phase 1 results for DLX-001, a novel neuroplastogen under development for the treatment of major depressive disorder. These results were originally shared at the 2024 American College of Neuropsychopharmacology Annual Meeting in Phoenix, Arizona.

This phase 1, 3-part study enrolled 106 healthy volunteers with the primary objectives of assessing safety, pharmacokinetics, and pharmacodynamic markers.

DLX-001 was associated with a generally safe, well-tolerated profile in healthy volunteers who received at least 1 dose of the treatment. Additionally, there was no evidence of psychotomimetic, hallucinatory, or dissociative effects, which are often seen in classic psychedelic treatments, at any dose level. Lastly, there were some effects in the brain that may hold promise for future studies of patients with depression.

Dr Koenig currently serves as chief medical officer for Delix Therapeutics, is a diplomate of the American Board of Psychiatry and Neurology, and retains active board certification in adult and geriatric psychiatry.