Asset profile

HS-10353

Small molecule

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Partialdesign only

Evidence outlook · results not reported

NCT05938179 · Major Depressive Disorder (MDD)

The lead study's design has limits that temper confidence (see the rationale below), and its results have not been reported. This tier describes the design, not an outcome.

NCT05938179: This is a well-designed randomized, quadruple-blind, placebo-controlled trial using a validated depression rating scale as its primary endpoint, but results have not yet been posted, so the outcome is unknown.

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Competitive landscape

72 competitors in this universe: 2 direct rivals (same mechanism and indication), 10 same-class, 60 same-indication; 33 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
HS-10353: this drugPhase 2Small moleculeGABA-A receptor
KH607Phase 3Small moleculeGABA-A receptor
GlyphAllo (allopregnanolone Prodrug) (SPT-300)Phase 2Small moleculeGABA-A receptor
Clobazam (Onfi)ApprovedSmall moleculeGABA-A receptor
DiastatApprovedCombinationGABA-A receptor
Diazepam (Valium)ApprovedSmall moleculeGABA-A receptor
Diazepam (Valtoco)ApprovedSmall moleculeGABA-A receptor
GanaxoloneApprovedSmall moleculeGABA-A receptor
Midazolam (Nayzilam)ApprovedSmall moleculeGABA-A receptor, GABA-A receptor (benzodiazepine site)
Phenobarbital Sodium Injection (Sezaby)ApprovedSmall moleculeGABA-A receptor
StiripentolApprovedSmall moleculeGABA-A receptor
Diazepam (Libervant)Phase 3Small moleculeGABA-A receptor
Staccato AlprazolamPhase 3CombinationGABA-A 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)

…and 57 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 2 (2)
Phase 1 (1)