Asset profile
Seltorexant
Small molecule
Evidence outlook · lead readout
NCT04533529 · Depressive Disorder, Major
The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.
NCT04533529: The initial treatment phase randomized 588 participants to seltorexant or matching placebo and kept participants and investigators blinded; among the prespecified efficacy population, the primary MADRS depression-score endpoint was significantly better with seltorexant at Day 43 (p=0.007). The subsequent one-year open-label phase continued participants from this randomized study and provides less controlled long-term safety information.
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; 9 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Seltorexant: this drug | Phase 3 | Small molecule | Orexin-2 receptor (OX2R) | ||
| 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
(2 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
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.