A psychedelic could win FDA approval within months. None ever has.
The agency compressed review of three psychedelic therapies from a year to weeks. A first approval decision is plausible by early 2027.
Treatment Resistant Depression
8 articles published between January 22, 2026 and August 14, 2026.
Six months after a repeat ketamine course, only 17% still counted as responders
The KADS extension followed 130 patients who had already been through a ketamine trial. Response fell from 30% at treatment's end to 17% a month later.
In veterans, psilocybin's anxiety relief tracked entirely with depression improvement
Anxiety, quality of life and PTSD symptoms all improved after a single dose in this 15-person trial. Once researchers accounted for depression improvement, those effects mostly disappeared.
Outside trials, psilocybin's real-world depression response rate ran lower
Switzerland allows limited psilocybin use for treatment-resistant depression. A review of 19 patients found meaningful improvement, but remission in barely a fifth to a quarter.
The largest psilocybin depression trial yet missed its primary endpoint
EPISODE randomized 144 people with treatment-resistant depression across four arms. High-dose psilocybin missed its main outcome, even as secondary measures showed symptom benefit.
A short-acting psychedelic was tested alongside SSRIs, not after stopping them
Most psychedelic depression trials require patients to come off antidepressants first. This one deliberately didn't — and found intranasal 5-MeO-DMT tolerable and encouraging in patients who stayed on their SSRI.
Women improved more than men on esketamine — and more on placebo too
A pooled analysis of five trials in treatment-resistant depression found sex differences in response. The largest ones appeared in both arms, which points at something other than the drug.
Implanted vagus nerve stimulation held its benefit into a second year in severe depression
In the RECOVER extension, about a fifth of participants were in remission at 24 months and some who had not responded at 12 months did later. The second year had no control group.