Words by GOLD newsdesk
A psychedelic-based treatment for people with treatment-resistant depression (TRD) has entered Phase 2 clinical trials, with the first patient now dosed, according to a press release.
Developed by Atai Life Sciences, the Elumina study is investigating a buccal film formulation of N,N-Dimethyltryptamine, more commonly known as DMT. The psychedelic compound is found in certain plants, but can also be produced synthetically in laboratories, opening up the possibility of using it therapeutically.
The drug VLS-01 is designed to fit into a two-hour interventional psychiatry model, making it a potentially faster-acting alternative to traditional antidepressants, which can take weeks to take effect.
Kevin Craig, Chief Medical Officer, Atai, called the Phase 2 trial a “significant milestone” in the company’s mission to transform the treatment landscape for mental health disorders. “With VLS-01, we see the potential to offer rapid, robust and durable antidepressant effects that could provide meaningful relief where existing treatments fall short,” he said. TRD is said to affect around 100 million people worldwide.
The trial will enrol 142 patients and results are expected in early 2026. If successful, VLS-01 could contribute to a growing field of psychedelic-based treatments for mental health conditions. Earlier this year, the FDA approved Johnson & Johnson’s esketamine nasal spray also for treatment of TDR.
