Asset profile

Zelquistinel

Small molecule

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Negativelead readout

Evidence outlook · lead readout

NCT03726658 · Major Depressive Disorder

The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.

NCT03726658: The study randomized 226 participants overall to several zelquistinel dose groups or placebo and masked both participants and investigators, but it stated that no power calculation was performed and each comparison was relatively small. The primary MADRS comparisons were clinical measures but were missed, with all reported p-values above 0.05, so the findings provide limited evidence of benefit.

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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.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Zelquistinel: this drugPhase 2Small moleculeNMDA receptor
Esketamine (Spravato)ApprovedSmall moleculeNMDA receptor
AV-101Phase 3Small moleculeNMDA receptor
ACP-211Phase 2Small moleculeNMDA receptor
Arketamine (PRT042)Phase 2Small moleculeNMDA receptor
BI 1569912Phase 2Small moleculeNMDA receptor
BlixeprodilPhase 2Small moleculeNMDA receptor
CLE-100Phase 2Small moleculeNMDA receptor
OnfasprodilPhase 2Small moleculeNMDA receptor
ALA-3000Phase 1Small moleculeNMDA receptor
SP-101Phase 1Small moleculeNMDA receptor
Amantadine ER (Gocovri / ADS-5102)ApprovedSmall moleculeNMDA 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

…and 52 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

(2 total)

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

2027 (1)
September 2027 (1)
Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2027-09 · NCT06547489 · CT.gov ↗
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2028 (1)
March 2028 (1)
Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2028-03-30 · NCT07115329 · CT.gov ↗
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See the full readout calendar ↗

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 (3)
Phase 1/2 (1)
Phase 1 (2)