Company Reports Positive Topline Results from Pivotal US Trial of LSD-Based Drug for Anxiety

United States biopharmaceutical company Definium Therapeutics announced on 12 August that its Phase 3 “Voyage” trial of DT120 — an orally disintegrating tablet formulation of lysergide, better known as LSD — met its primary endpoint and key secondary endpoints in adults with generalised anxiety disorder (GAD). The announcement drew wide coverage in health and industry press, including STAT News and Fierce Biotech.

What the company reported

According to the company’s release, Voyage enrolled 214 adults with GAD across about 35 US sites, randomised to a single 100-microgram dose of DT120 or placebo, with a 12-week double-blind period followed by an open-label extension. The company reports the trial met its primary endpoint — change in anxiety symptoms at week 12 on a standard clinician-rated scale — and key secondary endpoints, with differences from placebo the company says were observable from the first days after dosing.

These are topline results announced by the company; the full dataset has not yet been published in a peer-reviewed journal, and the figures in the release are company statements about a product under development, not independently verified findings.

What happens next

Definium says DT120 holds the US Food and Drug Administration’s breakthrough therapy designation for GAD, and that results from a third Phase 3 trial, “Panorama”, are expected in September 2026. According to Fierce Biotech, Panorama includes a lower-dose control arm designed to test blinding integrity — a recurring methodological question in psychedelic trials, where participants often recognise whether they received an active drug. The company reported positive topline Phase 3 results for the same drug candidate in major depressive disorder in June 2026 and is also developing it for post-traumatic stress disorder.

The Australian picture

None of this changes anything about access in Australia. Australia’s 2023 rescheduling decision covers psilocybin and MDMA only — LSD was not included and remains a Schedule 9 prohibited substance nationally, with no authorised-prescriber pathway for any indication. GAD is likewise not an indication for which any psychedelic can be prescribed here. Any future Australian availability of an LSD-based medicine would require a sponsor to seek TGA registration — a separate process that has not been announced. Outside approved clinical trials, LSD remains illegal to possess or supply in every Australian state and territory.

This article reports company statements and regulatory developments; it is not evidence about any treatment’s effects, and it is not medical advice.

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