Head-to-head evidence

Diazepam (Valium) vs Diazepam (Valtoco)

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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Diazepam (Valtoco)

Marketed by Neurelis, Inc.

Approved in Epilepsysmall molecule
Weak signal

NCT02721069 · Phase 3 · completed

The study was open-label, nonrandomized, and had no placebo or active comparator, so it provides uncontrolled safety and treatment-exposure information rather than comparative evidence of effectiveness. Its primary endpoint was the number of participants receiving NRL-1 over 12 months, not a hard clinical seizure outcome, and no formal primary-endpoint comparison was applicable.

Next expected readout: December 2026 · NCT06346262 (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 · Diazepam (Valtoco)'s landscape