Psychedelic research timeline
PTSD: the psychedelic research timeline
PTSD contains psychedelic medicine’s most advanced and most publicly scrutinised development story. Two positive MDMA Phase 3 trials led to an FDA filing, but trial-design and data-integrity concerns produced a rejection rather than an approval.
Milestones are editorially selected from Blossom’s research catalogue. Future markers are limited to important trials with dated public guidance and are shown as planned, not promised.
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Building the MDMA case
2000 to 2016Small patient trials turn an underground practice into a clinical programme.2000-01
MAPS
ended earlyThe first patient trial is shut down
A MAPS-funded low-dose pilot in Madrid for women with chronic PTSD is terminated before it can finish.
José Carlos Bouso runs the first controlled MDMA trial in patients anywhere, six women with chronic post-traumatic stress disorder after sexual assault, at low doses. It is terminated in 2002 under political pressure on the hospital, and the results are only published in 2008.
The trial ended for reasons that had nothing to do with what it found. That is worth stating plainly, because the canvas contains several stopped studies and the registry almost never distinguishes between a safety signal, a funding failure and an administrative decision taken by someone who never read the protocol.
It also set the pattern for the next two decades. MAPS-funded work is repeatedly the first of its kind, small, and conducted in whatever jurisdiction will permit it.
2004-03
MAPS
The first US patient trial
Michael and Annie Mithoefer open the randomised pilot in Charleston that produces the field’s founding efficacy result.
Twenty patients with chronic treatment-resistant post-traumatic stress disorder, randomised between MDMA-assisted therapy and an inactive placebo, run over six years in a single South Carolina practice. The 2010 publication reports that most people in the active arm no longer met diagnostic criteria, and it has been cited more than 650 times.
This is the number that built the field. Every later trial, every designation and the entire filing rest on the claim that a handful of supervised sessions can do what months of standard treatment often cannot.
Two caveats travelled with it from the start and were never resolved. Twenty patients is a pilot, and comparing an intense psychoactive experience against an inert placebo means almost everyone knew which arm they were in. A 2012 follow-up reported that the improvements held for years and found no evidence of dependence, which strengthened the durability claim considerably. The FDA still considered the durability evidence insufficient fourteen years later.
2008-02
Battlefield ketamine and PTSD
A study of burned service members finds lower PTSD rates among those who received ketamine during their care.
Ketamine’s haemodynamic stability (it does not drop blood pressure the way most anaesthetics do) made it standard in military and trauma medicine long before psychiatry noticed it. This retrospective study asked whether that incidental exposure left any psychiatric trace.
It is a correlation in a wounded population, not a trial, and the sickest patients get different anaesthetics for reasons that also predict PTSD. A later retrospective in 274 war-wounded soldiers is also in Blossom’s set and complicates the picture rather than confirming it.
Kept here because it shows the actual sequence: the signal came from noticing something in routine care, and the trials followed.
Breakthrough to Phase 3
2017 to 2023Two pivotal trials report positive results and Australia creates a clinical route.2018-06
Lancet Psychiatry
Dose-response trial in first responders
A randomised dose-response Phase 2 in veterans, firefighters and police officers publishes in Lancet Psychiatry.
Twenty-six participants, three MDMA doses, blinded and randomised. The higher doses outperformed the lowest, which is the kind of internal dose-response gradient that makes a drug effect more believable than a simple drug-versus-placebo comparison does.
The population is the strategic point. Veterans and first responders are the constituency that gave MDMA its political coalition in Washington, and the reason a compound criminalised in 1985 could be discussed sympathetically in Congress by 2020.
2018-11
MAPS Public Benefit Corp
MAPP1, the first psychedelic Phase 3
The first pivotal trial of any psychedelic-class medicine opens across the US, Canada and Israel.
MAPP1 is the first Phase 3 trial of a psychedelic-class compound anywhere. It opened thirty-two years after MAPS was founded and thirty-three years after the ban, funded by donations rather than by an investor round.
Reaching a pivotal trial at all was the achievement. Whether the design could survive regulatory scrutiny was a separate question, and the answer arrived six years later.
2021-05
Nature Medicine
MAPP1 publishes in Nature Medicine
The first pivotal psychedelic trial reports a large effect in severe PTSD. It is the most-cited MDMA trial in Blossom.
Ninety participants with severe post-traumatic stress disorder, randomised, double-blind, placebo-controlled. The MDMA arm improved substantially more than placebo on the standard clinician-administered severity scale, with no serious adverse events attributed to the drug. The paper has been cited more than 940 times.
On the day it published, this looked like the end of the argument. A criminalised compound had produced a positive pivotal result on the most difficult psychiatric indication in the book, and approval seemed a formality.
The design carried one weakness that the paper itself acknowledged and that no subsequent trial fixed. In the active arm, participants and therapists could almost always tell what had been administered, which means the measured effect includes an unknown quantity of expectation. A 2026 systematic review of blinding integrity across psychedelic trials put numbers on how large that problem is across the whole field.
2021-11
Stanford University
Magnesium-ibogaine in veterans
Stanford follows thirty veterans with blast exposure who travelled to a Mexican clinic, and publishes the results in Nature Medicine.
This study did something unusual and rather clever. Rather than trying to obtain approval to dose veterans with ibogaine in the US, the researchers assessed men who were already going to Mexico for treatment, before and after. Magnesium was co-administered specifically to blunt the QT effect, and no cardiac adverse events were reported.
The design is its own limitation, and the authors say so. There is no control group, no blinding and no randomisation, and the participants had selected themselves, paid to travel and expected to improve. Those are exactly the conditions under which self-reported symptom scores move a lot.
It is still the most consequential ibogaine paper of the decade, because it put the compound in Nature Medicine, in a veterans population, at a moment when veterans’ mental health had US political attention. The follow-up imaging and phenomenology papers landed in 2026, and the Texas appropriation two markers down is downstream of this study more than of any other.
2023-07
Therapeutic Goods Administration
Australia reschedules MDMA
Authorised psychiatrists can prescribe MDMA for PTSD, more than a year before any regulator rules on a product.
From 1 July 2023 the Australian Therapeutic Goods Administration permits specifically authorised psychiatrists to prescribe MDMA for post-traumatic stress disorder, alongside psilocybin for treatment-resistant depression. Australia becomes the first country in the world to allow it.
This is a different theory of access from the one the whole rest of this canvas assumes. There is no approved product, no marketing authorisation and no agreed label. There is a named prescriber who has satisfied an ethics committee and the regulator, treating one patient at a time.
It turned out to matter more than anyone expected, because thirteen months later the FDA route closed. Since August 2024, Australia has been the only jurisdiction where MDMA-assisted therapy is lawfully available as a treatment rather than as a trial, and the data now accumulating there is real-world rather than randomised.
2023-09
Nature Medicine
MAPP2 confirms the result
The second pivotal trial reports in Nature Medicine, in a broader moderate-to-severe population.
MAPP2 enrolled 104 participants with moderate to severe post-traumatic stress disorder and reproduced the MAPP1 finding in a wider population. Two positive pivotal trials is the conventional threshold for a US filing, and this is the point at which the company had a package.
A separate open-label extension study, for participants who wanted further sessions, completed in the same month. Both records sit in Blossom.
Replication of an effect does not replicate away a design flaw. Both studies compared MDMA against an inactive placebo, so both inherit the same unblinding problem, and running a study twice does not resolve a criticism that applies to how it was run.
2023-10
Portland VA Research Foundation
The VA runs its own group trial
A Portland VA study of group MDMA therapy for veterans completes, a year after the federal rejection.
Group-MVP tested MDMA-assisted therapy delivered to veterans in groups rather than one to one, and completed in September 2025. Group delivery attacks the cost problem directly: the therapist time around each session is the single largest expense in this treatment model, and one clinician cannot supervise one patient for eight hours at scale.
The sponsor is a Veterans Affairs research foundation, not a drug company. Public research kept going after the rejection because the population it serves did not change, and the academic and veteran lane on this canvas is now busier than the commercial one.
Rejection and diversification
2024 onwardsThe FDA refuses the filing while public and non-MDMA research continues.2024-08
U.S. Food and Drug Administration
ended earlyFDA issues a Complete Response Letter
The application is refused. The regulator asks for a new Phase 3 trial, and the company cuts most of its staff.
On 9 August 2024 the FDA issues a Complete Response Letter for NDA 215455. A complete response is a refusal: the application cannot be approved in its current form. Three deficiencies were cited. Adverse events with a positive valence, the ones that bear on abuse potential, were not systematically captured. The durability evidence was insufficient. And the proportion of participants with prior MDMA experience was too high to interpret the results cleanly.
The remedy the FDA asked for was a new Phase 3 trial. That is not a paperwork fix. It is several years and a large amount of money, demanded of a company whose entire value was the application that had just been refused.
The fallout was immediate. Lykos cut around three quarters of its staff, its chief executive departed, and Rick Doblin left the board of the company his non-profit had created. In the same month three MDMA papers were retracted from Psychopharmacology over unreported alleged misconduct at a Phase 2 site, which sharpened the data-integrity criticism considerably.
This is the most important marker on the canvas and the honest reading of it is uncomfortable in both directions. Two positive pivotal trials were not enough, which tells you something real about how weak an unblinded psychiatric trial is as evidence. It also left an indication with few effective options no closer to a new treatment, and a field that had told itself approval was inevitable had to stop saying so.
2025-12
University of São Paulo
A small ayahuasca–esketamine PTSD trial opens
A University of São Paulo study compares ayahuasca and oral esketamine in ten people with PTSD. Its scale makes this a feasibility signal, not a competing evidence base.
The trial is one of three small studies opened by the same Brazilian group. Only this one recruits a clinical PTSD population.
Its registry completion date was July 2026 while the record remained recruiting, so the schedule should be treated as provisional.
2026-09
COMPASS Pathways
plannedCOMPASS opens Redefine in PTSD
A Phase 2/3 in post-traumatic stress disorder, registry-listed to run to September 2029.
COMPASS takes COMP360 into a second indication with a combined Phase 2/3 in PTSD, following a Phase 2 safety and tolerability study that completed in 2023. The registry lists completion in September 2029.
Indication expansion this early is a hedge. Treatment-resistant depression is now crowded with Usona, Helus and the AbbVie-backed programme all pointed at broadly the same patients, and PTSD is both large and, since the MDMA rejection in 2024, conspicuously unserved.
2026-10
U.S. Army Medical Research and Development Command
plannedThe US Army runs its own trial
A Phase 2 in serving military personnel, sponsored by US Army Medical Research and Development Command, is due to open in October 2026.
Two years after the FDA refused the application, the US Department of Defense is opening its own MDMA trial in serving service members. The registry lists a start in October 2026 and completion in October 2028.
Government sponsorship changes the incentives in a way worth naming. The Army has no product to sell and no share price, which removes the commercial motive that the advisory committee treated as a source of bias. It also has a large population with post-traumatic stress disorder and few good options, which is why it is here.
Whether it can solve the blinding problem the FDA raised is unknown. Nothing in the registry record suggests a novel control design.
PTSD
The MDMA programme that reached the FDA, and the field that continued after rejection
Research Landscape
What the registered trials connected to PTSD look like when you line them up. Counts come from Blossom’s trial records as of August 2026.
How fast is PTSD research growing?
SourcedRegistered trials by recorded study-start year; 8 earlier trials began before 2013. Click a year for the running total.
Don't read as total research effort: only registered trials with a recorded start date are counted (127 of 128 tracked). Recent years under-count because of registration lag; striped bars are still filling in or are planned starts.
What's live right now, and what stopped?
SourcedRegistry status of all 128 PTSD trials Blossom tracks. Orange marks trials recruiting or opening.
- Recruiting or opening
- 5140%
- Underway, not recruiting
- 65%
- Completed
- 4636%
- Stopped early
- 1411%
- Unknown / other
- 119%
Don't read stopped trials as failures: trials end early for funding, recruitment, and strategy reasons too. Status is as last synced from the registry; some 'recruiting' trials may already have finished.
Which compounds carry the PTSD research?
SourcedTrials per compound. Orange marks the most-studied compound.
Don't read shares as adding to 100%: a trial testing several compounds counts once per compound, and placebo comparator arms are not shown. Trial volume signals research attention, not evidence quality.
Publication Landscape
How the 355 papers Blossom links to PTSD line up by year, compound and journal. This is the psychedelic-relevant literature in Blossom's records as of August 2026, not the condition's full medical literature.
How has PTSD research grown?
SourcedTracked papers by publication year; 5 earlier papers published before 2012. Click a year for the running total.
Don't read as total output: only the 355 of 355 tracked papers with a recorded publication date are counted, and these are the psychedelic-relevant papers Blossom tracks, not a complete bibliography. The current year is still filling in.
Which compounds shape PTSD?
SourcedTracked papers per compound. Orange marks the largest literature.
A paper studying several compounds counts once per compound, and placebo comparator arms are not shown. These are the psychedelic-relevant papers Blossom tracks.
Where is PTSD research published?
SourcedTracked papers per journal. Orange marks the most-used journal.
Counts the journal recorded on each tracked paper; papers without a journal on file are omitted. Blossom tracks psychedelic-relevant papers rather than each journal's full catalogue.