Asset profile

Mebufotenin (5-MeO-DMT) · GH001

Small molecule

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Evidence outlook · lead readout

NCT05800860 · Treatment-resistant Depression

The completed lead evidence is positive, with design limits that temper confidence; the rationale below says which.

NCT05800860: The study randomly assigned 81 participants and used quadruple blinding with a placebo comparator. Its primary endpoint was the change in MADRS depression scores from baseline to Day 7. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.

Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

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Competitive landscape

66 competitors in this universe: 7 direct rivals (same mechanism and indication), 0 same-class, 59 same-indication; 24 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Mebufotenin (5-MeO-DMT) (GH001): this drugPhase 2Small molecule5-HT2A receptor
CYB003Phase 3Small molecule5-HT2A receptor
Lysergide Tartrate (LSD) (DT120)Phase 3Small molecule5-HT2A receptor
Psilocybin (COMP360)Phase 3Small molecule5-HT2A receptor
BPL-003 (mebufotenin Benzoate)Phase 2Small molecule5-HT2A receptor
BretisilocinPhase 2Small molecule5-HT2A receptor
VLS-01Phase 2Small molecule5-HT2A receptor
ELE-101Phase 1/2Small molecule5-HT2A receptor
Brexpiprazole (Rexulti)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
Cariprazine (Vraylar)ApprovedSmall moleculeDopamine D3/D2 receptor (partial agonist)
Cyclobenzaprine (Tonmya)ApprovedSmall molecule5-HT2A, α1-adrenergic, H1-histaminergic, and M1-muscarinic acetylcholine receptors (functional antagonism)
Dextromethorphan / Bupropion (Auvelity)ApprovedSmall moleculesigma-1/NMDA
Esketamine (Spravato)ApprovedSmall moleculeNMDA receptor
Lumateperone (Caplyta)ApprovedSmall moleculeSerotonin 5-HT2A / dopamine D1-D2 receptor
Olanzapine / Fluoxetine (Symbyax)ApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist); serotonin transporter (reuptake inhibitor)
Solriamfetol (Sunosi)ApprovedSmall moleculeDopamine/norepinephrine transporter

…and 51 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(1 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2028 (1)
March 2028 (1)
Phase 15-methoxy-dimethyltryptamine (5-MeO-DMT)Recruiting
Est. primary completion 2028-03-01 · NCT07444788 · CT.gov ↗
What to watch
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 2 (4)
Phase 1/2 (3)
Phase 1 (8)