COMP360 psilocybin for treatment-resistant depression: where FDA approval stands

Where the practice stands

Promising, and not available yet

Labyrinth Psychiatry Group, the practice this site refers readers to, sees psilocybin as a promising treatment and hopes to offer it as soon as it is available and appropriate safeguards are in place. It does not offer psilocybin therapy today.

That is Labyrinth's position, set out in its November 6 psilocybin update for New Jersey patients. Advanced Depression Care is an education site run by LA Digital Systems; it does not treat patients or offer any treatment. This guide covers the same ground for anyone with treatment-resistant depression who is following COMP360, with every fact re-checked on November 8, 2026.

The drug

What COMP360 is

COMP360 is a synthetic psilocybin made by Compass Pathways and studied for treatment-resistant depression: depression that has not improved enough after other treatments.

• Compass describes it as an investigational treatment. In its trials it was given as one 25 mg dose, or two doses three weeks apart, under supervision.
• It has FDA Breakthrough Therapy designation and, since April 24, 2026, a national priority voucher. Both can speed a review. Neither is an approval.
• A second psilocybin drug, Usona Institute's PSIL201 for major depressive disorder, also holds an FDA priority voucher, BioSpace reports. A trade publication reported on November 2 that Usona has completed its FDA application. Usona would not comment, and we found no confirmation from Usona or the FDA as of November 8.

Mebufotenin (BPL-003 and GH001), a different, short-acting psychedelic, is also being studied for treatment-resistant depression; our mebufotenin guide covers where it stands.

The timeline

Where FDA approval stands, date by date

The most important line is the last one: no FDA decision date has been announced.

Each row was read from the source linked in it on November 8, 2026. The November 8 row reflects Compass's own announcements and its SEC filings; we will update this page when Compass files or the FDA acts.

After the filing

What still has to happen before anyone can be treated

1. Compass completes its application.Its rolling application is “nearing completion, with rolling review underway,” Compass said on November 3.
2. The FDA reviews it.Compass says its national priority voucher “could shorten review times to 1-2 months.” That is a target, not a promised date.
3. Rescheduling.Compass says COMP360 contains a Schedule I controlled substance and “must be rescheduled before commercializing.” The April 18, 2026 executive order tells the Attorney General to “initiate and complete review of any product containing a Schedule I substance that has successfully completed Phase 3 clinical trials for a serious mental health disorder,” so rescheduling “may proceed as quickly as practicable” for products the FDA approves. The order itself approves nothing.
4. Rules for how it is given. In research, the FDA's July 2026 guidance expects “observation by two monitors for the duration of the treatment session,” because people “may remain in a vulnerable state for several hours or longer,” and, if the lead monitor is not a physician, an on-call physician able to reach the site within 15 minutes. The rules for an approved product would come with its approval.

The evidence

What the trials found, in response and remission

A response means a person's depression score fell by at least half. Remission means the score fell low enough that few or no symptoms were left. Those are the standard ways to report results in treatment-resistant depression.

Reading the numbers.In the two published trials that compared one 25 mg dose with a placebo-like dose, about 4 in 10 people responded (37% and 42%), against 1 to 2 in 10 in the comparison groups (18% and 11%), and about 3 in 10 were in remission (29% and 25%), against about 1 in 10 (8% and 9%). The 2022 trial's authors write that “no definite conclusions can be drawn” from its response and remission figures, because of how its statistics were planned, and by week 12 the difference was no longer statistically significant. The 2021 trial found no significant difference from escitalopram on its main measure.

Both Phase 3 trials met their main goal, according to Compass. On the 60-point scale, the difference between groups at week 6 was 3.6 points in one trial and 3.8 in the other. The company reports a 25% drop in symptoms, a lower bar than a response; the February, July and November releases we read do not give the share of people who reached the standard 50% drop.

What Compass added in July and November. Compass reported on July 7 that the 39% in COMP006 kept their benefit, on average, through week 26. Its July slides count 48 people in remission at week 6, of 269 in the 25 mg group with week-6 results, and say that 28% of those who had improved but were not yet in remission got there after an additional dose. Compass labels that slide a post hoc analysis, meaning it was done after the trial's main results. On November 3 it also described 52-week open-label results from COMP005 as showing added benefit from one more dose. These are company-reported figures.

Compass reports that side effects in its Phase 3 trials were mostly mild or moderate, with “the vast majority resolving within 24 hours.”

Your options

Where COMP360 would sit next to treatments available today

If COMP360 is approved, it would join options for treatment-resistant depression that are already available. The table shows where each one stands today.

Status lines come from this site's treatment pages and, for SPRAVATO, its prescribing information. For a side-by-side on cost and coverage, see TMS, SPRAVATO and ketamine compared.

Timing matters if you hope to join a trial.Compass's first Phase 3 trial (COMP005) excluded anyone who had TMS in the six months before screening, and anyone who had ECT, deep brain stimulation or vagus nerve stimulation during the current episode. Each trial sets its own rules, so ask before you start a new treatment.

Safety

Side effects, and who the trials left out

The trials screened people carefully. Several groups were not studied at all.

• Common side effects.In COMP005, the most common were “headache, nausea and visual hallucination.” In the 2022 trial, adverse events occurred in 179 of 233 participants (77%) and included headache, nausea and dizziness.
• Heart and blood pressure. NIDA: “Psilocybin typically raises blood pressure and heart rate, which may be dangerous for people with heart conditions.”
• Suicidal thoughts.In the 2022 trial, “suicidal ideation or behavior or self-injury occurred in all dose groups,” including the 1 mg group. Across both Phase 3 trials, Compass reported in February that serious suicidal ideation occurred in fewer than 1% of participants, and that the one serious suicidal-behavior event was in the 1 mg group.
• Serious adverse events. Through 26 weeks in COMP006, Compass reports these in 5.7% of the 25 mg group and 6.3% of the 1 mg group.
• Who was excluded. COMP005 excluded people with past or current bipolar disorder or any psychotic disorder, and anyone who had been a psychiatric inpatient in the past 12 months. Another psilocybin trial (NCT06308653) excluded people with elevated blood pressure, certain heart conditions, or a first-degree relative with a psychotic disorder or bipolar I disorder. These are research rules; an approved label could differ.

Do not self-treat

Why mushrooms and “microdose” products are not the same thing

COMP360 is a measured, synthetic dose given under supervision in research. Mushrooms and edibles are neither.

NIDA says the health risks of psilocybin show up “particularly when unsupervised and outside of a research study and clinical supervision,” and that some candies marketed as containing psilocybin “have also been found to contain toxic chemicals and have caused severe illness.” In 2024, the CDC counted 180 illnesses, 73 hospitalizations and 2 deaths in 34 states linked to Diamond Shruumz chocolate bars, cones and gummies and other mushroom-marketed chocolates, 3 of the illnesses in New Jersey. Testing of some of the products found psilocin, muscimol, kavalactones and other substances, according to CDC's 2026 report. If someone has taken a product like this and is very unwell, call 911.

The law

New Jersey and other states

New Jersey's 2026 law pays for psilocybin research at three hospitals. It does not license clinics, and no hospitals had been announced as of November 8, 2026.

• The law. P.L.2025, c.296, approved January 20, 2026, creates the Psilocybin Behavioral Health Access and Therapy Pilot Program in the Department of Health, with an 11-member advisory board.
• Where and how much.One hospital each from the northern, central and southern regions, with $2 million to each of the three ($6 million in all). Union County, home of Labyrinth's Cranford office, is in the central region with Middlesex, Monmouth and Mercer.
• Rules.The Department of Health may not set any requirement that “conflicts with protocols and guidelines from the United States Food and Drug Administration related to clinical trials for psychedelic substances.”
• Timing.A request for proposals to hospitals within 180 days of the law, and selections within 60 days after that. The pilot “shall commence upon the selection of hospitals.” Until then, there is no pilot to join.
• Other states. Oregon and Colorado license psilocybin programs under state law (Oregon for adults 21 and older, with no prescription; Colorado listed 12 standard and 35 micro healing-center licenses as of October 30, 2026). These are not FDA-approved treatment, and Oregon notes psilocybin is “still a Schedule I substance” under federal law.

Research studies

Psilocybin trials you can check, with care

Joining a study is the only way to receive psilocybin as a depression treatment today.

On November 8, 2026, ClinicalTrials.gov listed 11 recruiting studies within about 60 miles of Cranford, New Jersey that match a psilocybin search, most in New York City, and not all of them for depression. The only New Jersey site was in Toms River, for CYB003, a compound related to psilocybin, in major depressive disorder. Read each study's eligibility rules with your psychiatrist before you change treatment.