Head-to-head evidence
Diazepam (Valium) vs Ganaxolone
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
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.
Ganaxolone
Marketed by Immedica Pharma AB
NCT01963208 · Phase 3 · completed
The primary phase was well controlled, with randomized quadruple blinding, placebo comparison, and 350 analyzed participants, and it used the clinical endpoint of change in seizure frequency. However, the primary endpoint was missed: the difference between ganaxolone and placebo was not statistically significant (p=0.1788), so the study provides well-designed but inconclusive evidence.
The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: Diazepam (Valium)'s landscape · Ganaxolone's landscape