Asset profile
ALTO-203
Small molecule
Evidence outlook · lead readout
NCT06391593 · Major Depressive Disorder, Anhedonia
The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.
NCT06391593: The study was randomized and quadruple-blind, with placebo control and 69 participants, using a crossover design for single doses and parallel groups for 28 days of dosing. Its primary efficacy measure was a pharmacodynamic mood and alertness scale rather than a hard clinical outcome, and the primary comparison cannot be judged because results are not posted.
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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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
61 competitors in this universe: 0 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 24 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| ALTO-203: this drug | Phase 2 | Small molecule | Histamine H3 receptor (antagonist / inverse agonist) | ||
| Pitolisant (Wakix) | Approved | Small molecule | Histamine H3 receptor (antagonist / inverse agonist) | ||
| 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) |
…and 46 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
No upcoming readouts on record for this asset.
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.