Asset profile

AV-101

Small molecule

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Negativelead readout

Evidence outlook · lead readout

ELEVATE (NCT03078322) · 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.

ELEVATE (NCT03078322): The study was randomized and quadruple-blind, compared AV-101 with placebo, and enrolled 180 participants; its primary endpoint was the clinical MADRS-10 depression score. Because the registry does not report whether the primary endpoint was met, the trial provides promising design information but no confirmed evidence of benefit.

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.

Also in development:Parkinson's Disease · Phase 2

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Competitive landscape

127 competitors in this universe: 11 direct rivals (same mechanism and indication), 0 same-class, 116 same-indication; 27 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
AV-101: this drugPhase 3Small moleculeNMDA receptor
Amantadine ER (Gocovri / ADS-5102)ApprovedSmall moleculeNMDA receptor
Esketamine (Spravato)ApprovedSmall 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
ZelquistinelPhase 2Small moleculeNMDA receptor
ALA-3000Phase 1Small moleculeNMDA receptor
SP-101Phase 1Small moleculeNMDA receptor
Apomorphine (Apokyn)ApprovedSmall moleculedopamine
Apomorphine Sublingual Film (Kynmobi)ApprovedSmall moleculedopamine
Brexpiprazole (Rexulti)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
Cariprazine (Vraylar)ApprovedSmall moleculeDopamine D3/D2 receptor (partial agonist)

…and 112 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

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.

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