Asset profile
CLE-100
Small molecule
Evidence outlook · lead readout
SOLEO (NCT06340958) · Adjunctive Treatment of Major Depressive Disorder (MDD)
The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.
SOLEO (NCT06340958): The study randomized 99 participants to double-blind CLE-100 or placebo alongside standard antidepressants. Its clinical primary endpoint, change in MADRS score at 29 days, was not statistically significant (p=0.15), so the results provide real but inconclusive evidence of benefit.
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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
67 competitors in this universe: 10 direct rivals (same mechanism and indication), 1 same-class, 56 same-indication; 25 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| CLE-100: this drug | Phase 2 | Small molecule | NMDA receptor | ||
| Esketamine (Spravato) | Approved | Small molecule | NMDA receptor | ||
| AV-101 | Phase 3 | Small molecule | NMDA receptor | ||
| ACP-211 | Phase 2 | Small molecule | NMDA receptor | ||
| Arketamine (PRT042) | Phase 2 | Small molecule | NMDA receptor | ||
| BI 1569912 | Phase 2 | Small molecule | NMDA receptor | ||
| Blixeprodil | Phase 2 | Small molecule | NMDA receptor | ||
| Onfasprodil | Phase 2 | Small molecule | NMDA receptor | ||
| Zelquistinel | Phase 2 | Small molecule | NMDA receptor | ||
| ALA-3000 | Phase 1 | Small molecule | NMDA receptor | ||
| SP-101 | Phase 1 | Small molecule | NMDA receptor | ||
| Amantadine ER (Gocovri / ADS-5102) | Approved | Small molecule | NMDA 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 |
…and 52 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.
Compare head-to-head
4 further head-to-head pairs are tracked; the rosters on each shared mechanism and indication page list every rival in the race.
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.