Asset profile

Staccato Alprazolam

Combination

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Phase 3underway

Evidence outlook · registrational

Epilepsy: registrational readout pending

Entered Phase 3 on reliable signal mid-stage evidence. Registrational readout expected around 2026-10-31.

StATES (NCT03478982): The study randomized participants to Staccato alprazolam or matching placebo and was described as quadruple-blind, with 156 participants enrolled and 38, 38, and 40 participants in the evaluable 1.0-mg, 2.0-mg, and placebo groups, respectively. Its primary clinical endpoint—seizure cessation within 2 minutes without recurrence for 2 hours—was statistically significantly better with both alprazolam doses than with placebo.

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Competitive landscape

72 competitors in this universe: 9 direct rivals (same mechanism and indication), 3 same-class, 60 same-indication; 43 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Staccato Alprazolam: this drugPhase 3CombinationGABA-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
KH607Phase 3Small moleculeGABA-A receptor
GlyphAllo (allopregnanolone Prodrug) (SPT-300)Phase 2Small moleculeGABA-A receptor
HS-10353Phase 2Small moleculeGABA-A receptor
BrivaracetamApprovedSmall moleculeSynaptic vesicle glycoprotein 2A (SV2A)
Cannabidiol (Epidiolex)ApprovedSmall moleculeGPR55 / TRPV1 / adenosine transport (multi-target), cannabinoid
CarbamazepineApprovedSmall moleculeSodium channels

…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.

Compare head-to-head

3 further head-to-head pairs are tracked; the rosters on each shared mechanism and indication page list every rival in the race.

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)
October 2026 (1)
Phase 3EpilepsyRecruiting
Est. primary completion 2026-10-31 · NCT05077904 · CT.gov ↗
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2028 (1)
November 2028 (1)
Phase 3EpilepsyEnrolling by invitation
Est. primary completion 2028-11-30 · NCT05076617 · CT.gov ↗
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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 (2)
Phase 2 (2)
Phase 1 (8)
Appears in other studies (1)