Incannex Healthcare has said its PSX-001 oral synthetic psilocybin programme for generalised anxiety disorder could benefit from a new White House executive order aimed at accelerating access to psychedelic treatments for serious mental illness.

The executive order, signed by President Donald Trump on 18 April, directs FDA to prioritise reviews of psychedelic compounds with Breakthrough Therapy designation, create Right to Try pathways for investigational psychedelic medicines and begin Drug Enforcement Administration rescheduling after successful Phase 3 completion.

Incannex said the policy could improve regulatory pathways for PSX-001, its investigational synthetic psilocybin treatment for generalised anxiety disorder (GAD), as psychedelic drug developers seek clearer routes to commercialisation.

The company’s programme is based on Phase 2 clinical trial data from Australia, where PSX-001 was tested in 73 patients with GAD. According to Incannex, the study showed a 12.8-point reduction in Hamilton Anxiety Rating Scale (HAM-A) scores compared with a 3.6-point reduction in the placebo group.

The company also reported that 44% of patients receiving PSX-001 achieved a clinically meaningful response, defined as at least a 50% reduction in anxiety symptoms, compared with 11% in the placebo arm. A remission rate of 27%, defined as a HAM-A score of seven or below, was sustained through 11 weeks.

Incannex said no serious adverse events were reported during the trial, with one patient discontinuing treatment.

Joel Latham, chief executive officer of Incannex, said: “We agree with the Administration’s recognition that the mental health crisis in America demands a new level of regulatory urgency and scientific ambition.

“For years, patients suffering from debilitating anxiety disorders have had limited options, particularly for those who fail first-line treatments.”

He added that PSX-001 “is designed for exactly these patients and this Executive Order represents a meaningful step toward ensuring that novel, evidence-based therapies like ours can reach them without unnecessary delay.”

Generalised anxiety disorder affects an estimated 280 million people worldwide, including around 6.8 million in the USA, according to figures cited by the company.

Incannex said its US investigational new drug application for PSX-001 is active and that it plans to continue advancing the programme toward later-stage clinical development.

The company is also developing therapies for obstructive sleep apnoea and rheumatoid arthritis, although PSX-001 marks its entry into the growing psychedelic medicines sector, where several developers are seeking regulatory approval for treatments targeting mental health disorders including depression, post-traumatic stress disorder and anxiety.

The White House order could signal a shift in how federal agencies approach psychedelic therapies, potentially easing long-standing regulatory barriers that have slowed clinical progress across the sector.