White House Order Boosts Psychedelic Drug Momentum
The biotechnology company Compass Pathways welcomed the Trump administration’s move, calling it an important step toward addressing the mental health crisis.
Compass CEO Kabir Nath said the executive order “recognizes the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA-approved psychedelics could have.”
Nath said the policy “aligns regulatory urgency with patient need” and supports “accelerating access, without compromising rigorous science.”
He added that the company’s synthetic psilocybin drug, COMP360, has shown “highly statistically significant and clinically meaningful data” in Phase 3 trials for treatment-resistant depression.
The company said trial results involving more than 1,000 patients showed symptom improvement within one day for some participants, with effects lasting up to six months after one or two doses in responders.
Most side effects were described as mild or moderate and resolved within 24 hours.
Compass said it is working with the FDA on a rolling submission for potential approval and is also advancing trials for post-traumatic stress disorder.
Trump Orders FDA To Speed Psychedelic Drug Reviews
President Donald Trump signed an executive order directing the FDA to fast-track reviews of psychedelic-based therapies, including ibogaine, as part of efforts to expand mental health treatment options.
The move aimed to accelerate research into drugs being studied for conditions like post-traumatic stress disorder and depression, with officials saying successful trials could lead to faster approvals and possible reclassification.
The administration also set aside $50 million for ibogaine research.
FDA Commissioner Marty Makary said regulatory decisions on psychedelic treatments could come as early as this summer, while Health and Human Services Secretary Robert F. Kennedy Jr. supported exploring their use for mental health care.
Trump said the policy reflected a shift away from long-standing stigma around psychedelic substances and growing acceptance of their medical potential.
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