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Psychedelics in 2024: From Hype to Hard Realities

In a video address to supporters reflecting on 2024, MAPS founder Rick Dobin proclaimed: “This year has tested us like never before.”

While Johns Hopkins researchers had us bracing for the bursting of the psychedelic hype bubble back in 2022, it seemed clear that different corners of society were at different phases of the ‘hype cycle’. Many ‘insiders’—academics, researchers, and practitioners familiar with psychedelics—were already over the peak of inflated expectations by 2023, and other groups, like Indigenous people, might not be represented on Gartner’s schematic at all. The public and political classes, meanwhile, still seemed on the way up the hype curve in 2022 and 2023, with positive media attention, depictions in TV series, and enthusiasm among lawmakers and their constituents.

In 2024, however, it seems that a critical mass has tipped over that peak and is well on the way toward the trough of disillusionment, with psychedelic hype thoroughly called into question, or at least tempered, by academics, practitioners, regulators, nonprofits, the media, and even the public.

Perhaps the most prominent case of this hype bubble being pierced was FDA’s rejection of Lykos Therapeutics’ MDMA-assisted therapy for PTSD new drug application (NDA), which had been deemed a shoo-in by many in the field, as well as popular media. (A poll on prediction market Metaculus had approval odds of 70%, and Vox reporter Sigal Samuel was 85% sure the FDA would give MDMA the nod.) The whole process associated with the review of that NDA, some of which took place publicly, generated reams of negative press not only for Lykos and MAPS, but also for psychedelic therapy and science more broadly. More on that later.

Beyond Lykos’ shortcomings, certain academics, researchers, and other commentators continued to challenge the validity of psychedelic science more broadly, with such critiques apparently emboldened by FDA’s skepticism.

 But it wasn’t all bad news. 2024 did see the arrival of government funds for psychedelic research, including from the VA and the NIH (NIDA alone will provide up to $14M to Gilgamesh and $15M to NYU researchers), as well as from the European Union and Poland’s Medical Research Agency. Some in the field are hopeful that such funds will only be more forthcoming in the US with the new Trump administration, though the likelihood of that is debated. Again, more on that later.

And, there were some wins on the research, drug development, and policy fronts, too—even if the most prominent stories were often sobering, or at least reminders of the work that lay ahead.

Here, I take a brief look at some of 2024’s most salient events and trends in the field. It is certainly not intended to be a comprehensive review of the year gone by, but rather a brief thematic look at just some of the topics that come to mind. I then take a look at the year ahead.

Lykos Therapeutics’ MDMA Rejection Dominates Headlines

In many ways, the FDA’s decision to reject Lykos Therapeutics’ MDMA for PTSD NDA set the tone for much of the year, with the heady optimism of its earlier months soon giving way to pessimism and skepticism come Spring, and defeat by August.

I won’t rehash what happened here, for we have covered that extensively (find links to some of our key coverage here).

Many had hoped that MAPS’ historic attempts to have Lykos ‘do things differently’—from its nonprofit drug development origins through to things like pairing a drug with psychotherapy—would be rewarded with an approval, but in reality it seems the sponsor was instead doing things on ‘hard mode’.

There also appear to be cases where Doblin and co. tried to do what they believed was the ‘right thing’, as opposed to taking the most FDA-friendly or expedient path, which a more conventional drug developer might take. Those include pairing the drug with a largely unproven suite of non-pharmacological interventions and Doblin’s inviting of ICER (a pharma foe!) to review its intervention.

In other cases, the MDMA drug developer seems to have been plain sloppy. Its NDA submission was missing basic safety data and the whole process was mired in discussion around both accepted and alleged incidents and misconduct in its studies.

And then there are contextual factors like changing staff at the FDA, which might have meant that the agency’s views, and the goalposts for approval, shifted as time went on. That might be especially relevant for MAPS/Lykos’ MDMA program, which took decades to reach a submission; much longer than your average program.

Another obvious shift during the development program was the move from Doblin-led MAPS ownership of the studies and protocol to a for-profit spin-out, which ultimately became Lykos Therapeutics. Lykos sought to recast the development program and protocol into a neater, more FDA-friendly package, moving from things like ‘MDMA-assisted therapy’ to ‘midomafetamine capsules’ for PTSD, hiring staff and leadership from more conventional pharma companies, and clumsily attempting to obtain a patent on something, anything, related to its investigational MDMA product. Doblin, meanwhile, thinks much of this was misguided, advocating instead for a more transparent, verbose approach to explaining its decisions around its decidedly different NDA.

Throughout the process, some corners of the field have relegated discussion of these shortcomings to ‘Monday morning quarterbacking’ (a phrase this Brit has since learned). But if we don’t assess our failures in an attempt to learn lessons, are we a maturing field at all? It certainly feels more constructive than screaming ‘FDA bad!’, crediting Psymposia as the single-handed destroyer of the nine-figure program, or hand-waving about a big pharma conspiracy, anyway.

Investors and Drug Developers Pursue Shorter-Acting, or Non-Hallucinogenic, Psychedelics—But the Subjective Experience Isn’t Entirely Off the Menu

As was to be expected, investors and drug developers continued a trend toward funding and prioritising shorter-acting, or non-hallucinogenic entirely, programs in 2024.

That trend was exemplified in the messaging of companies like Beckley Psytech and atai Life Sciences, with the latter ploughing $50M into the former in January 2024. The pair have been keen to emphasise that their candidates, like Beckley’s IV psilocin and 5-MeO-DMT programs, might fit neatly into the type of care delivery structure carved out by Janssen’s esketamine nasal spray, Spravato, with a two-hour-ish treatment window.

Taken to the extreme, this trend—which is focused on the palatability, scalability, and affordability of psychedelics-based medicines—led to continued efforts to engineer out the trip entirely, with so-called psychoplastogens (or neuroplastogens) another key area of focus in 2024. That trend is perhaps best embodied in pharmaceutical giant AbbVie’s first foray into the field via its collaboration with Gilgamesh Pharmaceuticals, announced in May. Through that deal, it looked like AbbVie was dipping its toes into psychedelic drug development, but the company quickly told Psychedelic Alpha that it was exclusively interested in and collaborating on psychoplastogens, not psychedelics.

But it’s not all short-acting or non-hallucinogenic. By the end of 2024, several Phase 3 programs were underway for psychedelics across three decidedly hallucinogenic candidates: Compass Pathways’ and Usona Institutes’ studies of psilocybin for treatment-resistant depression (TRD) and major depressive disorder (MDD), respectively; Cybin’s studies of its deuterated psilocybin candidate for MDD; and, MindMed’s studies of its LSD candidate for generalised anxiety disorder (GAD).

What’s more, ibogaine startup Soneira Bio raised $25M from investors including Google co-founder Sergey Brin, and (as aforementioned) NIDA funded Gilgamesh’s development of an ibogaine candidate
 ibogaine being perhaps the most potent, long-acting, and commercially-infeasible psychedelic-type drug out there. The types of investors who backed Soneira are generally distinct from the larger, more traditional biotech investors that are pursuing shorter-acting or nonhallucinogenic versions, like those invested in Delix Therapeutics, for example.

We take a closer look at these themes in our forthcoming 2024 Year in Review segment on psychedelic fundraising and our latest edition of the Psychedelic Drug Development Bullseye Chart, to be released shortly.

Psychedelic Policy Reform Plateaus

2024 was relatively muted on the policy reform front, with limited progress at the state and local level and a notable failure in the November elections when Bay Staters declined to endorse Question 4, which would have established a regulated psychedelics program in Massachusetts.

That limited progress on the state front included the launch of a pilot program in Utah (though its impact remains unclear) and the fruits of working groups and task forces in states like Nevada and Vermont, with varying degrees of success for psychedelics advocates (Nevada’s task force called for a state-regulated psychedelics program, while Vermont did not go so far).

Oregon’s state-regulated psilocybin program had its first full calendar year in operation. Data is a little sparse, though soon to be more forthcoming, but estimates suggest around 8,000 clients have participated in the program to date. Recognising a lack of demand to support a robust array of license-holders, the Psychedelic Science Funders Collaborative is seeking to shore up the program with initiatives like digital advertising and psilocybin medical science liaisons, as we recently covered. Some service centres, like Ashland Healing Center (“the first and only black-owned” service centre when it opened in Spring) and The Journey, have closed.

What’s more, a further fifteen cities and one county voted to opt-out of psilocybin services in the November elections, and taxpayers are expected to continue to bail out the program’s financial shortcomings for some time yet.

Another year saw another set of psychedelics-related bills fail in the U.S.’ most populous state, too, as both SB 803 (“Heal Our Heroes Act”) and SB 1012 (“The Regulated Psychedelic Facilitators Act and the Regulated Psychedelic-Assisted Therapy Act”) failed in California, despite the Governor having asked for new psychedelics-related bills to be put across his desk back in 2023. But the state did manage to iron out an impasse caused by its obscure advisory committee, which we first reported on last January.

We also saw the Drug Enforcement Administration (DEA) resurrect its 2022 attempt to place two psychedelics—DOI and DOC—in Schedule I. DOI, in particular, is an important tool in psychedelics research, which is one reason why a group of scientists as well as lawyers and drug policy reform advocates coalesced in an effort to challenge the DEA’s move, which culminated in a hearing at the DEA headquarters in November. We now await the agency’s decision.

Beyond the U.S., Australia’s limited rescheduling of MDMA and psilocybin appears to remain a very small project, largely owing to the high costs of treatments.

The Year Ahead

Looking ahead, then, there are some key themes and topics to watch in 2025, which is sure to be a busy year.

Perhaps the most prominent story to follow is the potential impact of an incoming Trump administration, which some in the field expect to shake up psychedelic research (via, for example, a reorientation of NIH priorities and funding), drug development (changes at the FDA), and potentially even policy reform.

Whether that promise comes true will be a key theme to watch. One thing seems clear, psychedelic companies and nonprofits are going to do their best to capitalise on the change in administration, with both formal and informal lobbying and schmoozing efforts expected to intensify.

But as psychedelics enthusiasts and operators alike try to bend the ear of the Trump admin., one must wonder what our psychedelics predecessors might think of this cosying up to a decidedly right-wing government.

More generally, we have seen some pro-psychedelics politicians become thoroughly disgraced, with Matt Gaetz the latest such case. One has to wonder, too, whether the ‘bipartisan’ support for psychedelics might also fall foul of its most polarising figures—from leftie AOC to self-described knuckle dragger Rick Perry. Might this strategy end up ostracising each and every point of the political compass?

There are also questions about how compatible Trump’s appointees are with the various goals of the psychedelics field and drug developers. In one example, Trump’s slash-n-burn office, DOGE, appears keen to defund large swaths of the VA. Would that help or hamstring the agency’s ability to take a leading role in MDMA research and roll-out?

Whether the new administration will change Lykos’ fortunes is yet to be seen, too. Key storylines to watch will be whether the company can secure a new line of funding, and on what terms; how the VA involves itself in MDMA research and roll-out preparedness; the outcome of an independent review of its Phase 3 program; and so on. Doblin, meanwhile, is putting on a brave face1, saying there’s a 40% chance no additional Phase 3 study will be needed.

Also on the drug development side of things, all eyes will be on Compass Pathways’ first readout from its Phase 3 program of a synthetic psilocybin candidate (‘COMP360’) in treatment-resistant depression. It could be a make-or-break moment, not only for the company but also for confidence in this class of drug development more broadly.

The future of psychedelic policy reform is also in the balance, with many looking to see whether Colorado’s state-regulated psychedelics program—the second such system in the country—will prove to be more accessible than Oregon’s. And we should get more insight into Oregon’s program, too, as the state is set to provide regular cuts of data starting this year.

We will also see what’s next for the psychedelic policy reform movement, with lawmakers introducing bills across the states as we speak.

Much of this activity will take place in the U.S., however, with other regions largely neglected when it comes to psychedelic policy reform. Take Europe, for example; there’s little in the way of drug policy liberalisation when it comes to psychedelics. Growing concern around ketamine’s risks also threatens such efforts, with the UK expected to decide on whether to place it in the most criminalised class of drugs this year.

But, there are things to keep an eye on in Europe. PsyPal, an EU-funded study of psilocybin to ease psychological and existential distress in a variety of progressive illnesses like MS and COPD, is set to launch this year, the Polish government is funding a study of psilocybin for treatment-resistant depression, and an EU citizens initiative, PsychedeliCare, is aiming to collect over a million signatures. In the UK, meanwhile, a report on psychedelic research is set to be released in short order by the Parliamentary Office of Science and Technology.

There’s certainly plenty to follow in 2025.

Our Role

As the psychedelics field has expanded and contracted over the past half-decade, many of our peers on the media side of things have come and gone. In some ways, then, Psychedelic Alpha is like a cockroach!

That’s why I am so grateful to those of you who continue to read, engage with, and share our content, especially our Pα+ subscribers. Since we launched our paid subscription in November 2023 we have published around one hundred subscriber-only pieces of content, including exclusive interviews, scoops, and regular Bulletins. (Learn more and join today.)

Not all of that coverage has been rosy. Indeed, much of our 2024 reporting focused on the review of Lykos’ new drug application, which often saw us discussing negative events and stories. In that coverage, we tried to be fair, sharing the opinions and arguments of both sides of the debate, while attempting not to slide into bothsidesism.

Which brings me to a broader point. The stories we write at Psychedelic Alpha are intended for those looking for the inside track on the psychedelics field. Much of it is inside baseball, not written for a broader audience. Instead, our goal is to keep you—the people who make psychedelic research, policy, and practise tick—up to date, to challenge our collective assumptions, and to contribute to the progression of the field in our own small way.

(Externally, meanwhile, I am generally an advocate for the field, as well as broader issues like funding mental health care research and delivery, questioning drug policies, and so on.)

As we anticipate political upheaval, pivotal clinical trial readouts, and an uncertain future for psychedelic policy reform, 2025 is sure to be a busy year. I will do my best to ensure Psychedelic Alpha produces timely, insightful coverage of and for our shared field, and I thank you in advance for your support.

To Ken.

It wouldn’t be right to end this 2024 recap without mentioning Ken Jordan, a dear friend of many in the field who passed away last year.

I have many fond memories with Ken, who was a key node in the psychedelics scene, particularly in New York. Ken was a bit weird, and that’s why I liked him
 especially as the psychedelics field saw an influx of people like me (a bit square, nerdy). Being a young, often pessimistic Brit, I benefitted greatly from Ken’s wisdom, friendship, and—more than anything—seemingly relentless optimism.

He was also hilarious, witty, kind, authentic, and a master conversationalist
 and not of the phatic variety; almost every conversation with Ken was full of substance. He had a fundamental inclination for weeding out bullshit, which resonated deeply with me.

Ken is sorely missed, but his legacy lives on through the many projects he had a hand in, including Lucid News, as well as the many people he touched during his remarkable life, including this author.

To Ken.

Ken Jordan

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  1. As do some of Lykos’ biggest supporters, including Genevieve Jurvetson, who said recently that her 2025 ‘moonshot’ is to get MDMA approved by year-end. (She made these comments in January, meaning they fall outside of our Year in Review window and as such appear here only as a footnote!)