🫠 This Week in Psychedelics

Welcome to Tricycle Day. We’re the psychedelics newsletter that’s opening the velvet rope. Everyone else has to wait in line for this email. But you, dear Cyclist, are on the list. Right this way.

Here’s what we got this week.

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Rinse and repeat: A protocol of weekly repeated psilocybin doses may be effective for treating OCD.
Vine intervention: Ayahuasca therapy may reduce suicidal ideation in treatment-resistant depression.
Read the room: Psychedelics might work as treatments for autism, based on their impact on social-affective circuits.
You’re ok, boomer: Psilocybin reduced inflammatory markers in older adults, suggesting possible applications for aging-related disorders.
Spoiler alert: EEG brain wave patterns can predict psilocybin trip intensity.

Geaux off, kings: Louisiana’s Senate unanimously passed SB43 to fund ibogaine and psilocybin trials for opioid addiction and treatment-resistant mental illness.
Patch notes: Oregon’s governor signed HB4040 into law, updating the state’s existing psilocybin framework.
Any volunteers? Tennessee approved a bill to study psychedelic treatments for PTSD and addiction.
Floor it: A United States Senate Committee scheduled a hearing on legislation to fund psychedelics research and expand veteran treatment access.
Wait, what: Critics say Trump’s psychedelics push is less about mental health and more about Iran.

Ape in: Psychedelic biotech stocks surged after the Executive Order. Investors are betting regulatory tailwinds will translate into approvals.
Move fast, break trials: Now under accelerated timelines, the same psychedelic biotechs are feeling pressure to produce data that isn’t ready.
If you build it: Optimi Health is manufacturing ibogaine now, so they’re ready to supply U.S. demand if domestic programs take off.
Yeehaw: Beond is planting its U.S. headquarters in Austin as Texas and the nation double down on ibogaine.
Roll call: Helus Pharma is partnering with TARA Mind and VETS to boost veteran recruitment for its Phase 3 depression trial.

God mode: Astronomers created a complete synthetic universe indistinguishable from our own.
Closing ceremony: Lucid News went inside a psychedelic retreat focused on helping people die well.
Through the grapevine: Plants can hear rain and respond physiologically.
MAGA’s medicine: Rolling Stone traces how ibogaine went from countercultural curiosity to the darling molecule of the political right.
Meme of the week: When they ask if you have health insurance…

That’s our loose translation of the White House’s directive to the FDA re: psychedelic breakthrough therapies in last week’s Executive Order.

Well, seems like the message was received.

On Friday, the FDA gave out three Commissioner's National Priority Vouchers (CNPVs) to Compass Pathways, Otsuka, and Usona Institute. (CNPVs compress the FDA's final NDA review window from the usual 10-12 months down to one or two.)

Here’s what we know about the three picks.

FDA Commissioner Marty Makary said approvals could come as soon as this summer, but we kinda doubt it. No matter how fast the regulators can move, applications still need to be complete first. And last we checked, Compass is still planning for an end-of-year approval.

In related news, the DOJ finally rescheduled marijuana this week… sorta. Only FDA-approved products and state-licensed medical marijuana moved to Schedule III; recreational cannabis is still Schedule I. (The pros call this “bifurcated scheduling.”)

So, a word to the wise. If that precedent sticks, an FDA-approved psilocybin product might not change a thing for the millions of *ahem* self-medicating mushroom enjoyers in the U.S. 🫠

Metabolites get no respect, we tell ya. The FDA just accepted DemeRx’s investigational new drug application for DMX-1001, an oral noribogaine formulation targeting alcohol use disorder. This is the first time any ibogaine-related compound has been cleared for clinical trials in the U.S., and the head of the FDA got its name wrong on national television. (We’ll let it slide, Marty.)

So what's the difference? Noribogaine is ibogaine's principal metabolite, the thing your body converts ibogaine into. It lasts longer than ibogaine, feels less intense, and may have a more favorable safety profile, though that still needs to be proven out in larger trials. DemeRx, a wholly owned subsidiary of AtaiBeckley by the way, is aiming to kick off Phase 2 in 2027.

But worry not, purists (and Joe Rogan, if you’re reading this). They’re definitely not the only ones betting on iboga. Texas has committed $50M toward ibogaine clinical trials covering addiction, TBI, and PTSD. Mississippi and West Virginia have signed on to a growing multi-state consortium, and bills are moving in several other states. First they ignore you, then they mispronounce you, then you get approved.

Cardiology has the EKG. Radiology has the MRI. Psychiatry has, “So, how does that make you feel?”. ARPA-H thinks we can do better. The agency recently announced the first research teams for EVIDENT, a $139.4 million initiative to build more objective endpoints for rapid-acting behavioral health treatments. At least $50 million of those funds is earmarked for psychedelics specifically.

The lineup is stacked. On the industry side, Diamond Therapeutics is collecting Phase 2a psilocybin data for generalized anxiety disorder, and INVI MindHealth is identifying real-time biomarkers for psychedelic therapy. From academia, Johns Hopkins is contributing data from eight psilocybin trials, USC is comparing psilocybin alone vs. psilocybin plus mindfulness, and UW-Madison is figuring out which part of the psychedelic experience does the heavy therapeutic lifting.

Of course, the FDA just issued those priority vouchers for psilocybin and methylone. If it’s true that the tools to (objectively) measure whether these treatments work are still being built, then making approval decisions will be a little like grading the test before you’ve written the rubric. But hey, we’ll take progress over paralysis any day.

That’s all for today, Cyclists! Whenever you’re ready, here’s how we can help.

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DISCLAIMER: This newsletter is for educational and informational purposes only and is not intended as a substitute for professional medical advice. The use, possession, and distribution of psychedelic drugs are illegal in most countries and may result in criminal prosecution.