Asset profile

NRX-101

Small molecule

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Phase 3underway

Evidence outlook · registrational

Bipolar Depression: registrational readout pending

Its supporting mid-stage evidence has not yet been graded on this platform. The registry's posted readout date (2024-12-31) has passed without a status update. Check News for topline announcements.

Also in development:Major Depressive Disorder · Phase 2/3

How the evidence outlook works ↗

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.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
NRX-101: this drugPhase 3Small moleculeNMDA receptor (glycine site) + dopamine/5-HT 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
Esketamine (Spravato)ApprovedSmall moleculeNMDA receptor
Lumateperone (Caplyta)ApprovedSmall moleculeSerotonin 5-HT2A / dopamine D1-D2 receptor
Olanzapine / Fluoxetine (Symbyax)ApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist); serotonin transporter (reuptake inhibitor)
Solriamfetol (Sunosi)ApprovedSmall moleculeDopamine/norepinephrine transporter
Vortioxetine (Trintellix)ApprovedSmall moleculeSerotonin transporter + multiple 5-HT receptors
AmmoxetinePhase 3Small moleculeSerotonin/norepinephrine transporter
Ansofaxine HydrochloridePhase 3Small moleculeSerotonin/norepinephrine/dopamine transporter
AV-101Phase 3Small moleculeNMDA receptor
AzetukalnerPhase 3Small moleculeKv7 potassium channel
BrenipatidePhase 3PeptideGLP-1/GIP receptor (dual)
CYB003Phase 3Small molecule5-HT2A receptor

…and 45 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.

2026 (1)
December 2026 (1)
Phase 1Major Depressive DisorderNot yet recruiting
Est. primary completion 2026-12-31 · NCT07785102 · CT.gov ↗
What to watch
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2027 (1)
December 2027 (1)
Phase 2/3Major Depressive DisorderNot yet recruiting
Est. primary completion 2027-12-31 · NCT07227103 · CT.gov ↗
What to watch
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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 3 (1)
Phase 2/3 (3)
Phase 2 (2)
Phase 1 (1)