Incannex Healthcare PSX-001 Program Aligns with White House Executive Order Accelerating Access to Psychedelic Treatments for Serious Mental Illness
MELBOURNE, Australia and NEW YORK, April 22, 2026 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, today supports the White House Executive Order signed by President Donald J. Trump on April 18, 2026, titled, "Accelerating Medical Treatments for Serious Mental Illness." The Company believes its PSX-001 development program aligns with the goals outlined in the Executive Order and believes the data demonstrated to date, along with a more amenable regulatory environment, may provide significant hope for those suffering from anxiety disorders.
"We agree with the Administration's recognition that the mental health crisis in America demands a new level of regulatory urgency and scientific ambition," commented Incannex CEO Joel Latham. "For years, patients suffering from debilitating anxiety disorders have had limited options, particularly for those who fail first-line treatments. PSX-001, our oral synthetic psilocybin therapeutic for Generalized Anxiety Disorder, 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."
PSX-001: Rigorous Science, Compelling Data, a Clear Path Forward
PSX-001 is an oral, fixed-dose synthetic psilocybin formulation in development for Generalized Anxiety Disorder (GAD), a condition affecting an estimated 280 million people globally and approximately 6.8 million in the United States. In Incannex's completed Phase 2 clinical trial, PSX-001 demonstrated statistically significant and clinically meaningful improvements across all primary and secondary endpoints:
- 12.8-point reduction in HAM-A anxiety scores versus 3.6 points for placebo (p<0.0001)
- 44% rate of clinically meaningful response (≥50% anxiety reduction) — four times the placebo rate
- 27% remission rate (HAM-A ≤7) — five times the placebo rate, sustained through 11 weeks
- No serious adverse events and a single discontinuation across 73 patients
The Executive Order's direction to the FDA to prioritize review of psychedelic compounds with Breakthrough Therapy designations create Right to Try pathways for investigational psychedelics, and initiate DEA rescheduling upon successful Phase 3 completion. The move also addresses systemic barriers that have historically constrained the development and commercialization of this entire therapeutic category. Incannex views these measures as meaningfully reducing regulatory and commercial risk for the psilocybin class broadly.
"This Executive Order underscores what the clinical evidence has been telling us for years, that psilocybin and related compounds represent a genuinely transformative opportunity in mental health," Mr. Latham continued. "We are well-funded with over $70 million in cash and no debt, our U.S. IND is active, and we believe our Phase 2 data is among the strongest in the oral psilocybin space. We are advancing PSX-001 with urgency and scientific rigor, and we welcome a regulatory environment that shares that sense of urgency."
About PSX-001
PSX-001 is an investigational oral synthetic psilocybin therapeutic in development for Generalized Anxiety Disorder. Incannex completed a 73-patient Phase 2 clinical trial in Australia in 2025, reporting statistically significant and durable improvements in anxiety, functioning, depression, and quality of life measures. PSX-001 is the first oral synthetic psilocybin therapeutic in development for GAD.
About Incannex Healthcare Inc.
Incannex is leading the way in developing combination medicines that target the underlying biological pathways associated with chronic conditions, including obstructive sleep apnea, rheumatoid arthritis and generalized anxiety disorder. The Company is advancing three clinical-stage product candidates based on evidence-based innovation and supported by streamlined operations. Incannex's lead clinical program, IHL-42X, is an oral fixed-dose combination of dronabinol and acetazolamide designed to target underlying mechanisms and act synergistically in the treatment of obstructive sleep apnea. In a Phase 2 development program, IHL-675A is an oral fixed-dose combination of cannabidiol and hydroxychloroquine sulfate designed to act synergistically to alleviate inflammatory conditions, such as rheumatoid arthritis. Approved for Phase 2 clinical development, PSX-001 is an oral synthetic psilocybin treatment for the treatment of generalized anxiety disorder. Incannex's programs target disorders that have limited, inadequate, or no approved pharmaceutical treatment options. For additional information on Incannex, please visit our website at www.incannex.com.
Forward-Looking Statements
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Investor & Media Contacts
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