The quest by psychedelic drugs for full legitimacy in the pharmaceutical world has seen marked progress as well as (fewer) setbacks of late, and developers are hopeful that an important corner has been turned.
Timothy Leary is dead, but he could be on the outside looking in with a smile on his face as U.S. President Donald Trump’s latest executive order (EO) fuels a surge in investment in companies researching and developing psychedelic drugs to treat mental health issues. The EO, Accelerating medical treatments for serious mental illness, is intended to address the increasing burden of suicide and serious mental illness, which impacts more than 14 million Americans.
BioWorld tracked 152 clinical trial readouts across phases I through III in February 2026, up from 144 in January but down from 215 in December. Of those, 20 phase III trials reported positive results, while one failed to meet key endpoints. By phase, February’s updates consisted of 50 from phase I, 46 from phase II and 57 from phase III.
Positive results from the second of two phase III trials set Compass Pathways plc’s synthetic psilocybin treatment, COMP-360, on track for a potential U.S. FDA approval within a year as the first classic psychedelic cleared for treatment-resistant depression.
Hitting the primary endpoint on Compass Pathways plc’s Comp005 study of synthetic psilocybin, which the company billed as the first classic psychedelic to report phase III efficacy data, produced only a shrug from investors.
The discussion that preceded the June 4 U.S. FDA advisory committee vote against the approval of Lykos Therapeutics Inc.’s midomafetamine as a treatment for post-traumatic stress disorder could shine some light on the way forward for other sponsors developing psychedelics for approved medical use.
In the face of the short supply of venture capital, the U.K. biotech sector weathered the storm in 2023, raising a total of £1.25 billion (US$1.6 billion) across 69 deals. That was 6% down on 2022, but has to be seen against the backdrop of U.K. VC investment across all sectors falling by a massive 43%. With follow-on financing by quoted companies, biotechs raised £1.8 billion overall.
The steadily percolating psychedelic drug space stands poised to generate a near-term stream of potentially encouraging developments in a range of mental health disorders, including depression, anxiety, post-traumatic stress disorder and more.
Compass Pathways plc is poised to start the first ever phase III trial of the psychedelic drug psilocybin, after getting U.S. FDA backing for a study in treatment-resistant depression.
In the steadily heating-up psychedelics space, Wall Street is closely watching a number of players, among them Compass Pathways plc, which has slated an R&D update for Oct. 12. The check-in could provide guidance for investors on how the FDA regards COMP-360, the firm’s oral psilocybin for treatment-resistant depression (TRD). It could also help observers guess about the fate of pipeline prospects in the hands of others, including GH Research plc, advancing a would-be TRD fix derived from dried venom secreted by the Bufo alvarius toad.
