Head-to-head evidence

Diazepam (Valtoco) 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 (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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Ganaxolone

Marketed by Immedica Pharma AB

Approved in Epilepsysmall molecule
Partial signal

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.

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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 (Valtoco)'s landscape · Ganaxolone's landscape