When your sixth antidepressant fails and your psychiatrist starts mentioning electroshock therapy, you know you’ve entered the wilderness of treatment-resistant depression. Now Compass Pathways’ synthetic psilocybin COMP360 has cleared two Phase 3 trials, potentially offering the first psychedelic escape route from this medical dead end.
Phase 3 Results Show Promise
The biotech company announced that its 25mg dose met primary endpoints in both major studies. In the larger COMP006 trial with 581 patients, 39% achieved clinically meaningful depression reduction within six weeks—nearly double the control group. More striking: effects kicked in within 24 hours, not the weeks traditional antidepressants demand.
For patients in the smaller COMP005 trial who received a second dose, 70% maintained benefits at the six-month mark. This durability sets COMP360 apart from quick fixes that fade after initial promise.
Safety Profile Remains Clean
COMP360’s safety profile stayed consistent across both trials. Most side effects remained mild to moderate, resolving within a day. No new suicide risks emerged, addressing psychiatry’s biggest fear about experimental treatments.
The drug targets the same patients who might otherwise try Johnson & Johnson’s Spravato, which generated $1.7 billion in 2025 sales despite requiring twice-weekly clinic visits for ongoing ketamine infusions.
FDA Timeline and Regulatory Hurdles
Compass plans rolling FDA approval by Q4 2026, with approval projected for late 2026 or early 2027. The Schedule I designation complicates things—COMP360 will need DEA rescheduling and risk management protocols before reaching patients.
CEO Kabir Nath called the results a “remarkable achievement” for treating this “extraordinarily challenging” condition, though experts noted the improvements, while statistically significant, weren’t miraculous.
Cultural Shift in Mental Health Treatment
This represents more than biotech validation. If approved, COMP360 becomes the first “classic” psychedelic approved for medical use, shifting substances once associated with Woodstock into mainstream psychiatry. For the estimated 2.8 million Americans with treatment-resistant depression, it could mean hope where Prozac failed.
The stigma surrounding both psychedelics and mental health treatment continues dissolving—your therapist might soon be recommending magic mushroom derivatives with the same clinical detachment as blood pressure medication. The race now centers on regulatory execution rather than clinical proof. After decades in pharmaceutical purgatory, psychedelic medicine finally has its breakthrough moment.
