This year is set to be the year of psychedelics – Trump’s trip, you could call it. Since the President signed an executive order supporting the use of psychedelic medicines in April, no fewer than six federal agencies have announced initiatives to help usher the industry along. The agencies, mainly connected to the Department of Health and Human Services, have approved multiple million-dollar initiatives to research, approve and roll out psychedelics. A whole fleet of startups are now circling the Food and Drug Administration.

Three of these have Commissioner’s National Priority Vouchers from the FDA, which means that when they submit their new drug applications, the agency will make a decision within two months of filing. The startups are Compass Pathways, which is trialing a synthetic psilocybin (the active ingredient in magic mushrooms) for treatment-resistant depression; Usona, a nonprofit trialing psilocybin for major depressive disorder; and Transcend Therapeutics, which was recently bought by Otsuka for $1.2 billion. It is trialing a substance similar to MDMA to treat PTSD.

“Regulatory risk is now zero,” says Josh Hardman, founder of the newsletter Psychedelic Alpha. “The leading psychedelic start-ups have good enough data to be approved by any FDA, but with this FDA, with all the political pressure swirling around, I don’t see them not getting approved.”

The market expects either Compass or Usona to be the first classic psychedelic to be FDA-approved, later this year or early next year, but several other companies are snapping at their heels. There’s Definium, trialing LSD for generalized anxiety disorder; Resilient, seeking to resubmit its application of MDMA for PTSD; Reunion, trialing 4-HO-DiPT for post-partum depression; Gilgamesh, trialing non-hallucinogenic “neuroplastogens”; and DemeRx, trialing an analog of ibogaine for alcohol disorder.

A psychiatrist’s clinic could soon resemble the backpack of a high-end dealer at Burning Man

A psychiatrist’s clinic could soon resemble the backpack of a high-end dealer at Burning Man

AtaiBeckley has developed a synthetic, nasal-spray version of 5-MeO-DMT for treatment-resistant depression. The substance 5-MeO-DMT is derived from the secretions of the Colorado River toad and often called the “god molecule,” because users describe a state of feeling........

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