🫠 This Week in Psychedelics

PRESENTED BY SCHOOL OF PSYCHEDELICS 🤝

Welcome to Tricycle Day. We’re the psychedelics newsletter that breaks through all kinds of things. Stigma, limiting beliefs, even spam filters (on a good day). If you spot a broken link, though, that’s on us. Reply and we’ll get it fixed pronto. 👨‍🔧

Here’s what we got this week.

• The 6th psychedelic breakthrough therapy 💥

• AbbVie closes Gilgamesh bretisilocin deal 🤝

• Oregon facilitators reopen OHA discrimination case ♿️

• A new biography of Terence McKenna 📙

FROM OUR SPONSORS

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MICRODOSES

🔬 Research

The fourth dimension: Psychedelics distort our perception of time in substance-specific ways.
Heavy drinkers: Regular ritual use of ayahuasca is associated with increased psychological resilience.
Blood, sweat, and biomarkers: A review of nine studies identified several biomarkers that may predict who responds to psychedelic treatments.
Less is more: In a large international survey, psilocybin microdosing was linked to higher ratings of wellbeing, productivity, creativity, connectedness, contemplation, and focus.
No place like home: Kingston Health Sciences Centre is running the first Health Canada-approved clinical trial of at-home psilocybin microdoses for generalized anxiety disorder.

🏛️ Policy

Same same but different: Colorado voters decriminalized ibogaine along with psilocybin in 2022, but most agree ibogaine needs different rules.
Rise and shine: Rachel Yehuda, a clinical researcher for the VA, spoke on CBS Mornings about the therapeutic potential of psychedelics for veterans.
Lights, camera, legislation: Policymakers attended private ibogaine documentary screenings in both North Carolina and Texas to drum up support for expanded access.
Oh, Canada: A Nova Scotia man who was charged with drug offenses after leading ayahuasca ceremonies in his home walked with probation.

📈 Business

Recipe for growth: The psychedelic active pharmaceutical ingredient (API) market is predicted to reach $16.93 billion by 2034.
Branching out: Delix Therapeutics has unveiled a new neuroplastogen that promotes dendritic spine growth and functional plasticity like classic psychedelics and ketamine.
New name, who dis? DMT drug developer Algernon Pharmaceuticals rebranded to Algernon Health, reflecting its expansion into Alzheimer’s diagnostics.
IP-yote: Enveric Biosciences secured a new patent on mescaline derivatives.
Tech bro takeover: The watchdog org Psymposia released a 200-page report claiming Silicon Valley elites are trying to capture the psychedelic therapy industry.

🫠 Just for fun

How to change your mind: Learn 7 ways to increase your neuroplasticity that don’t (have to) involve psychedelics.
Erowid turns 30: BBC looks back on the drug website that transformed psychedelic research.
You’ve heard of Cali sober: Now get ready for Colorado sober.
MycoToilet: A microbiologist and architect teamed up to build a mushroom-powered outhouse that composts waste with no smell.
Meme of the week: Why seniors are flocking to psilocybin centers…

THE PEAK EXPERIENCE

The first rule of breakthrough therapy club

… is you absolutely talk about breakthrough therapy club. Especially when a new member joins.

This week, atai Life Sciences announced that its 5-MeO-DMT nasal spray (BPL-003) earned the FDA’s coveted breakthrough designation for treatment-resistant depression.

That makes six (6) psychedelic drug candidates on the list, but who’s counting? (Us. We’re counting.)

In the wake of the news, atai also closed a cool $150 million public offering to bankroll their ambitions. Not a bad week for ol’ atai.

So who else is in the club, and where are they now? Time for a roll call.

• 💗 MDMA for PTSD (Lykos Therapeutics, 2017): The breakthrough that, well, broke. Despite earning the designation first, Lykos got a Complete Response Letter in August 2024 saying the FDA wants another Phase 3 trial. Ouch.

• 🍄 COMP360 psilocybin for TRD (Compass Pathways, 2018): Just hit their primary endpoint in Phase 3 in June. They're chatting with the FDA about accelerated approval pathways and expect full 26-week data in late 2026.

• 🍄 Psilocybin for MDD (Usona Institute, 2019): The nonprofit launched its Phase 3 uAspire trial in March 2024 and is chugging along with ~240 participants across multiple sites.

• 🧪 MM120 (LSD) for GAD (MindMed, 2024): Currently dosing patients in not one, not two, but three Phase 3 trials—two for anxiety (Voyage and Panorama) and one for depression (Emerge). Results expected in late 2026.

• 🧬 CYB003 for MDD (Cybin, 2024): Their deuterated psilocybin analog is in Phase 3 (APPROACH), with a second pivotal trial (EMBRACE) launching Q4 2025.

A breakthrough therapy designation is more than a regulatory pat on the back. It comes with intensive FDA guidance, priority review, and a faster path to approval. But as Lykos learned the hard way, it certainly doesn't guarantee success.

For atai, the timing is ideal. They're in the process of merging with Beckley Psytech (the company behind BPL-003) and planning to kick off Phase 3 trials in Q2 2026. Now they’ve got the capital and tailwinds to bring it home.

The breakthrough psychedelics club is elite, no question. But you know what would be even cooler? Starting the FDA-approved club. 🫠

AFTERGLOW

Done deal

AbbVie officially closed its acquisition of Gilgamesh Pharmaceuticals' bretisilocin this week, marking maybe the biggest bet a major pharma company has ever made on psychedelics. ($1.2 billion, to be precise.) What’s interesting is AbbVie didn't buy all of Gilgamesh. They cherry-picked bretisilocin, while Gilgamesh spins off into a new entity that keeps the team, other pipeline assets, and an existing collab with AbbVie.

To understand what AbbVie sees in bretisilocin, look no further than the Phase 1 data just published. For one thing, the compound's 45-minute half-life creates a 90-minute psychedelic experience. Timing wise, that’s the sweet spot between psilocybin's 6-hour marathon and DMT's 15-minute sprint. It fits neatly into the two-hour, in-clinic model J&J established with Spravato, addressing one of the field’s biggest scalability problems.

Patent skirmishes aside, it’s a pretty clean deal. Gilgamesh gets to keep tinkering on other projects, like its NMDA antagonist and cardio-safe ibogaine analog. And AbbVie has the option to license future assets from the spinoff, too. In other words, this might not be the last Gilgamesh psychedelic that ends up in AbbVie's hands.

Willing and disabled

Cue the Law and Order theme song. A federal suit challenging Oregon's exclusion of homebound and disabled patients from psilocybin services is back in play. Last week, a group of Oregon facilitators filed a brief opposing the state's second attempt to get the case tossed. Meaning, the plaintiffs are still convinced Oregon Health Authority is discriminating against people with disabilities.

The state’s argument is handwavey procedural at best. They say these facilitators aren't the right parties to bring the case; it should be the clients themselves. The thing is, OHA already tried this move last year with a motion to dismiss on similar grounds, and it didn't work. Now they're repackaging the same argument. Meanwhile, the very Oregonians the Psilocybin Services Act was explicitly designed to serve are, yep, still locked out of access.

If the court agrees with the plaintiffs, Oregon will have to grapple with the real question: whether the current rules a) unlawfully exclude disabled clients or b) address legitimate safety concerns that outweigh access. Whatever happens, we’ll let you know. And we promise you won’t have to leave home to read our newsletter.

CYCLISTS’ PICKS

• 📕 New book: Strange Attractor is the first biography of one of the most celebrated and mysterious psychonauts of the modern era, Terence McKenna.

• ⛰️ Summit: The Psychedelic Lived Experiences Summit brings 50+ patients, trial participants, therapists, and researchers together to ask, what could the field learn from listening to the people it’s meant to serve? Registration is free.

• 🥫 Alcohol alternative: BREZ combines microdosed cannabis, functional mushrooms, and nootropics into fizzy beverages that kick in within five minutes and never leave us feeling anxious.

• 🚀 Online event: The Psychedelic Coach Accelerator is a 3-day online event for coaches and consultants who want to integrate psychedelics into their practice profitably, taught by a team that’s done it. Take 33% off tickets with code TRICYCLEDAY.

UNTIL NEXT TIME

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

ONE CYCLIST’S REVIEW

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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.