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Several other classic psychedelic candidates are in or approaching Phase 3. Definium Therapeutics, formerly MindMed, has reported three positive Phase 3 readouts for DT120, an orally disintegrating tablet formulation of LSD. The company reported results from Emerge in MDD in June, followed by Voyage and Panorama in generalized anxiety disorder (GAD). It plans to file for GAD in the first half of 2027. Helus Pharma, formerly Cybin, expects topline data this quarter from APPROACH, the first of two Phase 3 trials of HLP003, a deuterated psilocin analog being tested as an add-on treatment for MDD. It is targeting an NDA in 2028. Two short-acting 5-MeO-DMT candidates for TRD come next. AtaiBeckley reported starting Phase 3 activities for its intranasal BPL-003 in the second quarter. Eli Lilly completed its acquisition of AtaiBeckley in September in a deal valued at up to $3.8 billion including milestone payments. GH Research has selected doses for a global Phase 3 program of its inhaled GH001.
| Developer | Candidate | Indication | Status |
|---|---|---|---|
| Compass Pathways | COMP360 (synthetic psilocybin) | TRD | NDA submission completed Nov. 9; national priority voucher; Breakthrough Therapy designation |
| Usona Institute | Synthetic psilocybin | MDD | NDA completed, Psychedelic Alpha reported Nov. 2; national priority voucher |
| Definium Therapeutics (formerly MindMed) | DT120 (LSD, orally disintegrating tablet) | GAD, MDD | Three positive Phase 3 readouts; GAD filing planned for first half of 2027 |
| Helus Pharma (formerly Cybin) | HLP003 (deuterated psilocin analog) | MDD (add-on) | Phase 3 APPROACH topline expected fourth quarter 2026; NDA targeted for 2028 |
| AtaiBeckley (acquired by Eli Lilly) | BPL-003 (intranasal 5-MeO-DMT) | TRD | Phase 3 activities started second quarter 2026 |
| GH Research | GH001 (inhaled 5-MeO-DMT) | TRD | Doses selected for global Phase 3 program |
The Compass submission draws on data from two Phase 3 trials (COMP005 and COMP006) and a Phase 2b study, each of which met its primary endpoint. Together the studies enrolled more than 1,000 participants with highly chronic TRD. In COMP005, a single 25 mg dose of COMP360 produced a 3.6-point greater reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) versus placebo at week 6 (p < 0.001). In COMP006, two 25 mg doses given three weeks apart produced a 3.8-point greater MADRS reduction versus a 1 mg active control at the same time point (p < 0.001). Compass reported that improvements appeared the day after dosing in both trials and lasted through 26 weeks. In open-label follow-up from COMP005, Compass reported additional benefit through week 52 among participants who received another 25 mg dose.
COMP360 also holds Breakthrough Therapy designation from the FDA. The voucher program aims to shorten review to one or two months after the final application is submitted, compared with the usual 10 to 12 months, while preserving FDA safety and efficacy standards. Compass said its commercial preparations are on track for a potential U.S. launch in the first half of 2027, subject to FDA approval. Psilocybin remains a Schedule I controlled substance under federal law. Compass has said a U.S. launch would follow DEA rescheduling, and state scheduling rules could affect where it can launch.
TRD is defined as major depression that has responded inadequately to at least two courses of antidepressants at adequate doses and durations. Compass estimates that roughly 4 million people in the United States live with TRD, of whom fewer than 5% receive a therapy specifically indicated for the condition. The company is also conducting a late-stage trial of COMP360 in post-traumatic stress disorder.
“People living with treatment-resistant depression have gone too long experiencing disproportionate suffering,” said Kabir Nath, chief executive officer of Compass Pathways, in the filing announcement. Nath described Compass’s program as the largest late-stage clinical program for a psychedelic treatment.
COMP360 could become the first classic psychedelic cleared by the FDA. The agency had yet to publicly confirm formal acceptance of the application for review as of Nov. 9.
According to Investing.com’s historical price data, Compass shares rose 6.6% to $9.18 on Monday, recovering part of their 27.3% decline on Nov. 2 after Psychedelic Alpha’s report on Usona’s filing.
Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs, Regulatory affairs
