Asset profile
ALTO-300
Small molecule
Evidence outlook · no controlled comparison
NCT05118750 · Major Depressive Disorder
The lead study is single-arm or otherwise uncontrolled, so it produced no formal comparison against a control. This tier describes the design, not an outcome.
NCT05118750: The study enrolled 91 participants in a single-group, open-label design with no placebo or active comparator, and assessed clinical depression scales including MADRS and CGI-S. No primary-endpoint results have been posted, so the treatment effect cannot be compared with a control group or determined from the registry.
How the evidence outlook works ↗
Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 23 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| ALTO-300: this drug | Phase 2 | Small molecule | Melatonergic (MT) receptors (agonist) + serotonin receptor | ||
| Brexpiprazole (Rexulti) | Approved | Small molecule | Dopamine D2/D3 and serotonin 5-HT1A receptor | ||
| Cariprazine (Vraylar) | Approved | Small molecule | Dopamine D3/D2 receptor (partial agonist) | ||
| Cyclobenzaprine (Tonmya) | Approved | Small molecule | 5-HT2A, α1-adrenergic, H1-histaminergic, and M1-muscarinic acetylcholine receptors (functional antagonism) | ||
| Dextromethorphan / Bupropion (Auvelity) | Approved | Small molecule | sigma-1/NMDA | ||
| Esketamine (Spravato) | Approved | Small molecule | NMDA receptor | ||
| Lumateperone (Caplyta) | Approved | Small molecule | Serotonin 5-HT2A / dopamine D1-D2 receptor | ||
| Olanzapine / Fluoxetine (Symbyax) | Approved | Small molecule | Dopamine D2 and serotonin 5-HT2A receptors (antagonist); serotonin transporter (reuptake inhibitor) | ||
| Solriamfetol (Sunosi) | Approved | Small molecule | Dopamine/norepinephrine transporter | ||
| Vortioxetine (Trintellix) | Approved | Small molecule | Serotonin transporter + multiple 5-HT receptors | ||
| Ammoxetine | Phase 3 | Small molecule | Serotonin/norepinephrine transporter | ||
| Ansofaxine Hydrochloride | Phase 3 | Small molecule | Serotonin/norepinephrine/dopamine transporter | ||
| AV-101 | Phase 3 | Small molecule | NMDA receptor | ||
| Azetukalner | Phase 3 | Small molecule | Kv7 potassium channel | ||
| Brenipatide | Phase 3 | Peptide | GLP-1/GIP receptor (dual) | ||
| CYB003 | Phase 3 | Small molecule | 5-HT2A receptor |
…and 45 more. Research shows the complete landscape.
Unlock the full comparison
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.
2026 (1)
December 2026 (1)
What to watch
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.