Compass Pathways CEO wants a slow COMP360 launch to protect the psychedelics field
Compass Pathways expects to complete its rolling FDA submission for COMP360 this quarter and launch early next year, CEO Kabir Nath said. He wants a slow, provider-trained rollout under an expected REMS, because early bad experiences could damage the broader sector.
The Scientist · Science desk
Key figures: each COMP360 dose involves a supervised session of roughly 6 hours. Two sessions come to about 12 hours of supervised time per patient. A Compass analysis of recorded sessions found roughly 80% of the time was spent in silence.
| Figure | Value | Note | Claim |
|---|---|---|---|
| Supervised session per COMP360 dose | 6 hours, roughly | 8 | |
| Two sessions, per patient | 12 hours, about | 19 | |
| Session time in silence | 80% roughly | 5 |
What happened
- In Compass's Phase 3 trials, roughly a quarter of patients had a clinically meaningful response after one supervised session of about six hours, and about 40% after a second dose three weeks later.
- Nath said Compass is investing in training for the providers who would administer COMP360.
- Patients often know they received a psychedelic because of its effects, which can compromise trial blinding and was one concern when the FDA rejected Lykos Therapeutics' MDMA therapy in 2024.
- Nath said Compass deliberately kept psychotherapy out of its trials, arguing the company's job is to develop a drug and not to dictate how physicians provide psychological care.
Why it matters
- constraint If the expected REMS applies, the supply of trained providers would cap early access no matter how many patients want treatment.
- decision Compass has to hold a deliberate pace while officials in the Trump administration have voiced support for speeding psychedelic development.
- contradiction Nath's argument that the company's job is the drug sits against Hyman's point that researchers have yet to determine how much of the benefit comes from the drug itself.
- capability If the hallucinogenic experience proves unnecessary, compounds built without it could be prescribed for home use, which would remove the supervised sessions Compass is training providers to run.
The STAT report does not include the number of patients behind the Phase 3 response rates, or the response rate in the comparison group. The step from the first figure to the second is about 15 percentage points [20]. As STAT describes it, the rise is a comparison of the drug with itself at one dose and at two [8].
Nath said the company's longer-term data suggest that patients who respond can keep the benefit for as long as a year after two or three administrations [9]. That claim is conditioned on response, so its denominator is the responders, a subset of everyone treated.
Steven Hyman, a Harvard professor who used to direct the National Institute of Mental Health, warned that major scientific questions are still open, among them how trials can establish efficacy [10]. On blinding he was direct. "The unblinding remains a challenging problem," Hyman said [12].
Nath's case for keeping psychotherapy out of the trials has a number behind it. Recordings of treatment sessions, once analyzed, showed silence for roughly 80% of the time [5]. On a session of roughly six hours, that is about 4.8 hours [18]. Two sessions, the schedule behind the higher response figure, come to about 12 hours of supervised time per patient [19].
Hyman said that for the field to be credible, it would need rigorous research, responsible marketing and safety monitoring over the long term [14]. He compared the situation to cannabis, where early perceptions of safety did not anticipate all the risks of increasingly potent products [15].
Nath was less guarded about the upside. "I think this is a really big deal for patients, for providers, and incidentally for Compass Pathways as well," he said at the STAT Summit in Boston [6].
We think a slow launch is the right call on this evidence, with one condition. The REMS Nath expects, short for risk evaluation and mitigation strategy [2], and the provider training he described [3] govern how the drug is delivered. They do not answer the blinding question or the question of how much the experience contributes, and both sit in the trial data behind the submission [7]. Early next year is the company's aim, and it depends on approval [7].
What to watch
- Whether Compass completes the rolling submission this quarter, and whether any REMS the FDA attaches matches what Nath expects.
- Patient counts and comparison-group response rates behind the roughly one-quarter and about-40% Phase 3 figures.
- Efficacy data from developers of compounds meant to work without hallucinations, which would test whether the experience is needed.
Clarity's read
What the record supports and how the coverage leans. The claims behind it follow.
Reality
- Evidence50
- Adoption
- Insufficient
- Hype gap+10
- Incentives60
- Confidence55
Claim ledger
Ranked by verification strength, evidence, and original report placement.
- [1]
Speaking Wednesday in Boston at the STAT Summit, Nath said Compass will "go slow before we go fast," warning that negative patient or provider experiences early in the launch could damage the broader sector.
- [2]
Nath said the company expects COMP360, if approved, to be subject to an FDA risk evaluation and mitigation strategy, or REMS.
- [3]
Compass is investing in training for the providers who would administer the drug.
- [4]
Nath said Compass deliberately separated psychotherapy from its clinical trials, arguing that the company's responsibility is to develop a drug rather than dictate how physicians provide psychological care.
- [5]
An analysis of recorded treatment sessions found that roughly 80% of the time was spent in silence.
- [6]
"I think this is a really big deal for patients, for providers, and incidentally for Compass Pathways as well," Nath said, speaking in Boston at the STAT Summit.
- [7]
Compass Pathways is preparing to complete a rolling FDA submission this quarter for COMP360, its synthetic psilocybin treatment for treatment-resistant depression, with aims to launch early next year; the launch is contingent on approval.
- [8]
In Compass's Phase 3 trials, roughly a quarter of patients experienced a clinically meaningful response after a single administration of COMP360, which involves a roughly six-hour supervised session; that figure rose to about 40% after a second dose three weeks later.
- [9]
Nath said the company's longer-term data suggest that patients who respond to treatment can experience benefits lasting as long as a year after two or three administrations.
- [10]
Steven Hyman, a Harvard University professor and former director of the National Institute of Mental Health, cautioned that significant scientific questions remain about psychedelic treatments, including how to establish their efficacy in clinical trials.
- [11]
Patients who receive a psychedelic drug often know they have received it because of its distinctive effects, potentially compromising the blinding of trials; this was one concern when an MDMA-based therapy from Lykos Therapeutics was rejected by the FDA in 2024.
- [12]
"The unblinding remains a challenging problem," Hyman said.
- [13]
Hyman said researchers have yet to determine how much of the clinical benefit of psychedelic treatment comes from the drug's pharmacological effects and how much from the experience itself.
- [14]
Hyman said the field's credibility would depend on rigorous research, responsible marketing, and long-term safety monitoring.
- [15]
Hyman drew a comparison to cannabis, where early perceptions of safety did not anticipate all the risks associated with increasingly potent products.
- [16]
Officials in the Trump administration have expressed support for accelerating the development of psychedelic treatments.
- [17]
Some companies are developing compounds designed to produce antidepressant effects without hallucinations or other intense subjective experiences; if successful, such treatments could potentially be prescribed for patients to take at home, eliminating the need for lengthy supervised sessions.
- [18]
Roughly 80% of a roughly six-hour session is about 4.8 hours of silence.
- [19]
Two roughly six-hour supervised sessions come to about 12 hours of supervised time per patient.
- [20]
The step from roughly a quarter to about 40% is about 15 percentage points.
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Sources
1 independent publisher whose own reporting we read for this story.
- statnews.comCompass Pathways CEO: Psychedelics company will ‘go slow before we go fast’
1 article · October 14, 2026
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