Head-to-head evidence

Diazepam (Valium) vs Staccato Alprazolam

Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.

Epilepsy

Shared mechanism: GABA-A receptor · full Epilepsy pipeline

Diazepam (Valium)

Marketed by Roche

Approved in Epilepsysmall molecule
Weak signal

NCT03428360 · Phase 3 · completed

This was a single-group, open-label study with no randomization, blinding, or comparator arm; 149 participants were enrolled and 130 received study drug. Its primary safety outcomes were descriptive and had no formal between-group comparison, so the findings provide limited evidence for assessing diazepam buccal film.

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Staccato Alprazolam

Developed by UCB

Phase 3 in Epilepsysmall_molecule_device_combination
Reliable signal

NCT03478982 · Phase 2 · completed

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.

Next expected readout: October 2026 · NCT05077904 (registry estimate)

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The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: Diazepam (Valium)'s landscape · Staccato Alprazolam's landscape