| Candidate | Sponsor | Drug/Substance | Phase | Indication | N | Status | Readout Q/H | Readout Year | Our coverage | Registry link | BTD? | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BPL-003 | AtaiBeckley | Intranasal 5-MeO-DMT | Phase 2a | AUD | 12 | ✅ | Q1 | 2025 | Read ↗ | NCT05674929 | No | |
| BPL-003 | AtaiBeckley | Intranasal 5-MeO-DMT | Phase 2b | TRD | 193 | ✅ | Q3 | 2025 | Read ↗ | NCT05870540 | Yes | |
| BPL-003 | AtaiBeckley | Intranasal 5-MeO-DMT | Phase 2b | TRD | 107 | ✅ | Q4 | 2025 | Read ↗ | NCT05870540 | Yes | Open-label extension. |
| BPL-003 | AtaiBeckley | Intranasal 5-MeO-DMT | Phase 2a | TRD | 12 | ✅ | Q3 | 2025 | Read ↗ | NCT05660642 | Yes | Two-dose regimen. |
| BPL-003 | AtaiBeckley | Intranasal 5-MeO-DMT | Phase 2a | TRD | 12 | ✅ | Q2 | 2025 | Read ↗ | NCT05660642 | Yes | Single dose, adjunct to SSRIs. |
| BPL-003 | AtaiBeckley | Intranasal 5-MeO-DMT | Phase 2a | TRD | TBD | ⏳ | Q4 | 2026 | Yes | Two-dose (8 mg) induction reigimen as adjunct to ADs. | ||
| COMP360 | Compass Pathways | Psilocybin | Phase 3 | TRD | 258 | ✅ | Q2 | 2025 | Read ↗ | NCT05624268 | Yes | COMP005 Part A topline. |
| COMP360 | Compass Pathways | Psilocybin | Phase 3 | TRD | 572 | ✅ | Q1 | 2026 | Read ↗ | NCT05711940 | Yes | COMP006 Part A |
| COMP360 | Compass Pathways | Psilocybin | Phase 3 | TRD | 258 | ✅ | Q1 | 2026 | Read ↗ | NCT05624268 | Yes | COMP005 Part A + B |
| COMP360 | Compass Pathways | Psilocybin | Phase 3 | TRD | 572 | ✅ | Q3 | 2026 | NCT05711940 | Yes | COMP006 Part B, 'early' in the quarter. | |
| DLX-001 | Delix Therapeutics | Zalsupindole | Phase 1b | MDD | 18 | ✅ | Q4 | 2025 | Read ↗ | - | No | |
| DMX-1001 | DemeRx | Oral Noribogaine | Phase 1b | AUD | 55 | ❓ | Q1 | 2026 | Read ↗ | NCT06480981 | No | |
| DT120 | Definium Therapeutics | LSD D-tartrate ODT | Phase 3 | GAD | 200 | ⏳ | Q2 | 2026 | NCT06741228 | Yes | 'Voyage'. | |
| DT120 | Definium Therapeutics | LSD D-tartrate ODT | Phase 3 | GAD | 250 | ⏳ | H2 | 2026 | NCT06809595 | Yes | 'Panorama'. | |
| DT120 | Definium Therapeutics | LSD D-tartrate ODT | Phase 3 | MDD | 140 | ⏳ | Mid | 2026 | NCT06941844 | No | 'Emerge'. | |
| DT402 | Definium Therapeutics | R(-)-MDMA | Phase 2a | ASD | 20 | ⏳ | 2026 | NCT07303907 | No | Initial data expected some time in 2026. | ||
| EMP-01 | AtaiBeckley | Oral R-MDMA | Phase 2a | SAD | ~70 | ❓ | Q1 | 2026 | Read ↗ | NCT06693609 | No | |
| GH001 | GH Research | Inhaled 5-MeO-DMT | Phase 2b | TRD | 81 | ✅ | Q1 | 2025 | Read ↗ | NCT05800860 | No | |
| GH001 | GH Research | Inhaled 5-MeO-DMT | Phase 2a | PPD | 10 | ✅ | Q1 | 2025 | NCT05804708 | No | ||
| GH001 | GH Research | Inhaled 5-MeO-DMT | Phase 2a | BDII | 6 | ✅ | Q1 | 2025 | NCT05839509 | No | ||
| GM-1020 | Gilgamesh Pharma | Blixeprodil | Phase 2a | MDD | 46 | ✅ | Q1 | 2026 | Read ↗ | NCT06309277 | No | |
| GM-2505 | Gilgamesh Pharma | Bretisilocin | Phase 2a | MDD | 40 | ✅ | Q2 | 2025 | Read ↗ | NCT06236880 | No | Candidate now owned by AbbVie. |
| GM-2505 | AbbVie | Bretisilocin | Phase 2 | MDD | ⏳ | 2026 | No | |||||
| HLP003 | Helus | Deuterated Psilocin Analog | Phase 3 | MDD (Adjunctive treatment) | 220 | ⏳ | Q4 | 2026 | NCT06564818 | Yes | 'Approach'. | |
| HLP004 | Helus | IM Deuterated DMT Analog | Phase 2 | GAD | 36 | ✅ | Q1 | 2026 | Read ↗ | NCT06051721 | No | |
| MB22001 | MindBio Therapeutics | LSD (microdose) | Phase 2b | MDD | 89 | 🚫 | Q4 | 2025 | Read ↗ | ACTRN12624000128594 | No | Failed and abandoned. |
| MSD-001 | Mindstate Design Labs | 5-MeO-MiPT | Phase 1 | 47 | ✅ | H2 | 2025 | Read ↗ | NCT06702332 | No | ||
| PSX-001 | Incannex Healthcare | Psilocybin | Phase 2 | GAD | 73 | ✅ | Q3 | 2025 | Read ↗ | ACTRN12621001358831 | No | |
| RE104 | Reunion Neuroscience | Subcutaneous Luvesilocin (4-OH-DiPT prodrug) | Phase 2 | PPD | 84 | ✅ | Q3 | 2025 | Read ↗ | NCT06342310 | No | 'Reconnect'. |
| RE104 | Reunion Neuroscience | Subcutaneous Luvesilocin (4-OH-DiPT prodrug) | Phase 1 | PPD | 14 | ✅ | Q3 | 2025 | Read ↗ | NCT06659263 | No | |
| RE104 | Reunion Neuroscience | Subcutaneous Luvesilocin (4-OH-DiPT prodrug) | Phase 2 | AjD | 100 | ⏳ | 2027 | NCT07002034 | No | 'Rekindle'. | ||
| TSND-201 | Transcend Therapeutics | Methylone | Phase 2 | PTSD | 65 | ✅ | Q1 | 2025 | Read ↗ | NCT05741710 | Yes | |
| VLS-01 | AtaiBeckley | Buccal Film DMT | Phase 2 | TRD | 142 | ⏳ | H2 | 2026 | NCT06524830 | No | 'Elumina'. |
Status:
✅ Positive readout.
❓ Readout delivered. The company has not stated clearly whether it will progress the candidate.
🚫 Trial failed and/or the company has paused development.
⏳ Awaiting readout.
Indications: Alcohol Use Disorder (AUD); Treatment-Resistant Depression (TRD); Major Depressive Disorder (MDD); Generalised Anxiety Disorder (GAD); Autism Spectrum Disorder (ASD); Social Anxiety Disorder (SAD); Postpartum Depression (PPD); Bipolar II Disorder (BDII); Adjustment Disorder (AjD); Post-Traumatic Stress Disorder (PTSD).
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