The two companies racing to turn synthetic 5-MeO-DMT into an approved depression drug — BPL-003 vs GH001 — compared on trial data, delivery, timeline, and market position.
The race to commercialize 5-MeO-DMT comes down to two companies: AtaiBeckley and GH Research. Both are developing a synthetic version of the powerful psychedelic once known only from the Sonoran Desert toad, and both are aiming it at treatment-resistant depression. This guide compares their lead drugs, their trial results, their timelines, and the market thesis that has investors calling 5-MeO-DMT a potential billion-dollar treatment.
No company has won yet, and the Phase 2 data does not crown a clear leader. GH Research posted the larger headline effect, while AtaiBeckley ran the larger, more geographically diverse trial and holds FDA Breakthrough Therapy Designation. The race will be decided in Phase 3 and at the FDA, not by the Phase 2 numbers. For most observers, the deciding factors will be which program reaches approval first and which can prove a durable, easy-to-deliver treatment that insurers will pay for.
| Factor | AtaiBeckley (BPL-003) | GH Research (GH001) |
|---|---|---|
| Lead 5-MeO-DMT drug | BPL-003 — intranasal mebufotenin (5-MeO-DMT) benzoate. | GH001 — inhaled synthetic 5-MeO-DMT vapor. |
| Delivery | Nasal spray, single dose. | Inhaled vapor, individualized regimen (up to three escalating doses in one visit). |
| Lead indication | Treatment-resistant depression (TRD). | Treatment-resistant depression (TRD). |
| Phase 2b headline | Single 8 mg dose: -12.1 point MADRS reduction at Day 29; primary endpoint met. | -15.5 point placebo-adjusted MADRS reduction at Day 8; 57.5% remission vs 0% placebo. |
| Phase 2b size | 193 patients across 38 sites in six countries. | 81 patients (single-dose randomized design). |
| FDA designation | Breakthrough Therapy Designation for TRD. | US clinical hold on GH001 lifted in early 2026. |
| Corporate structure | Formed by the atai Life Sciences × Beckley Psytech merger (Nov 2025, ~$390M). | Standalone company focused on 5-MeO-DMT and related programs. |
| Stock listing | Nasdaq: ATAI. | Nasdaq: GHRS. |
AtaiBeckley and GH Research took different paths to the same molecule. One grew by merger; the other stayed focused as a single-asset specialist.
AtaiBeckley was created when atai Life Sciences and Beckley Psytech completed their strategic combination in November 2025, in a deal that valued Beckley at roughly $390 million. The merger pulled Beckley’s lead 5-MeO-DMT program, BPL-003, into a larger, better-capitalized company. Atai has said its cash runway extends into 2029, through the first Phase 3 readout for BPL-003. Beyond 5-MeO-DMT, the pipeline includes an N,N-DMT program (VLS-01) and an R-MDMA program (EMP-01).
GH Research is a clinical-stage company built around 5-MeO-DMT. Its lead asset, GH001, is an inhaled formulation delivered through a proprietary device. GH Research generated one of the most striking readouts in the entire psychedelic field with its Phase 2b trial, and the US clinical hold that had slowed its development was lifted in early 2026, clearing the way toward Phase 3.
Both companies met their Phase 2b goals, but the trials were designed differently, so the numbers are not a clean apples-to-apples comparison.
GH001 delivered the larger headline number. In the Phase 2b TRD-201 trial published in JAMA Psychiatry, GH001 produced a -15.5 point placebo-adjusted MADRS reduction at Day 8, with 57.5% of patients in remission in the drug arm versus 0% on placebo.1 The trial used an individualized dosing regimen — up to three escalating doses in a single day — and 97.4% of patients were ready to be discharged within an hour of their last dose. An open-label extension reported that most completers stayed in remission at six months with only one to four treatments.
BPL-003 met its primary endpoint in a larger, more diverse trial. The Phase 2b study enrolled 193 patients across 38 sites in six countries. A single 8 mg dose cut MADRS scores by 12.1 points at Day 29, with significant improvement seen as early as one day after dosing.2 There were no drug-related serious adverse events, and more than 99% of side effects were mild or moderate. The FDA has granted BPL-003 Breakthrough Therapy Designation for TRD, a status meant to speed review.
The delivery method is one of the biggest strategic differences between the two programs. BPL-003 is a nasal spray, which is familiar, portable, and easy for clinics to administer. GH001 is an inhaled vapor given through a dedicated device, using an individualized, escalating-dose approach within a single visit.
Both aim for the same commercial advantage: a very short experience. A 5-MeO-DMT session lasts roughly 15 to 30 minutes, so patients can be monitored and discharged the same day. That “dose-and-discharge” model is a sharp contrast to psilocybin, where a single session can fill most of a day. See our 5-MeO-DMT vs psilocybin guide for why duration matters so much to companies.
The investment case for 5-MeO-DMT rests on a comparison to Spravato. Spravato (esketamine) is Johnson & Johnson’s FDA-approved nasal-spray antidepressant for treatment-resistant depression, and it grew into a blockbuster with sales in the billions. Bulls argue that a 5-MeO-DMT product could follow the same playbook: an in-clinic, insurance-billable, rapid-acting treatment for a huge and underserved TRD population.
The optimistic pitch has three parts. First, the effect sizes in Phase 2 look large. Second, the treatment is durable, so patients may need very few sessions per year. Third, the short session length lets a clinic treat more patients per day than a psilocybin or MDMA model allows. If all three hold up in Phase 3, a 5-MeO-DMT drug could capture meaningful share of the antidepressant market.
Both programs are targeting Phase 3. AtaiBeckley has guided toward a Phase 3 start for BPL-003 and a cash runway into 2029 to reach the first Phase 3 data. GH Research is moving toward its own Phase 3 program now that the US hold is lifted. A first FDA approval for any 5-MeO-DMT product is still several years away and depends on those trials succeeding.
For investors, both companies are publicly traded — AtaiBeckley on Nasdaq as ATAI and GH Research on Nasdaq as GHRS — which makes them more accessible than the many private psychedelic startups. Both are high-risk biotech stocks whose value moves sharply on trial data and regulatory news. For a broader view of the sector, including ETFs and the other public players, see our psychedelic stocks and ETFs guide. This is general information, not investment advice.
GH Research has the more dramatic Phase 2 headline and a focused, single-molecule strategy. If its inhaled regimen holds up in Phase 3, its efficacy numbers are hard to ignore.
AtaiBeckley has the larger, more global trial, a convenient nasal-spray format, FDA Breakthrough status, and a stronger balance sheet after the merger. Those are exactly the assets that matter for finishing Phase 3 and reaching the market.
The honest answer is that the race is still open. The winner will be the first program to pair a clean Phase 3 result with a delivery model clinics and insurers embrace. Want to track it? Follow new trials with our clinical trial finder, or read the full 5-MeO-DMT guide for the science behind both programs.
No one has won yet — both AtaiBeckley and GH Research have positive Phase 2b data and are moving toward Phase 3. GH Research's GH001 (inhaled) posted a larger headline effect (-15.5 point placebo-adjusted MADRS at Day 8), while AtaiBeckley's BPL-003 (intranasal) ran a larger, multi-country Phase 2b (193 patients) and holds FDA Breakthrough Therapy Designation. The winner will likely be decided by Phase 3 results, FDA review, and commercial execution, not by the Phase 2 numbers alone.
Both are synthetic 5-MeO-DMT for treatment-resistant depression, but they differ in delivery and dosing. BPL-003 (AtaiBeckley) is an intranasal mebufotenin benzoate spray given as a single dose. GH001 (GH Research) is an inhaled vapor given as an individualized regimen of up to three escalating doses in one session. Both aim for a short, in-clinic, dose-and-discharge experience.
AtaiBeckley is the company created when atai Life Sciences and Beckley Psytech completed their combination in November 2025, in a deal valuing Beckley at about $390 million. Its lead asset is BPL-003, an intranasal 5-MeO-DMT for treatment-resistant depression. The company has said its cash runway extends into 2029, through the first Phase 3 readout.
It is a plausible bet, not a certainty. Analysts compare 5-MeO-DMT to Spravato (esketamine), the FDA-approved nasal-spray antidepressant that reached blockbuster sales, and argue a short, durable, in-clinic psychedelic could capture a large treatment-resistant depression market. But the drugs still need to pass Phase 3, win FDA approval, and secure insurance coverage before any billion-dollar forecast is real.
AtaiBeckley trades publicly (Nasdaq: ATAI) and GH Research trades publicly (Nasdaq: GHRS), so both are accessible to investors, unlike many private psychedelic startups. These are high-risk, pre-revenue biotech stocks whose value swings on trial data and FDA decisions. See our psychedelic stocks and ETFs guide for how the sector trades. This is not investment advice.
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