Head-to-head evidence

Diastat 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

Diastat

Marketed by Bausch Health

Approved in Epilepsysmall_molecule_device_combination
Partial signal

NCT03953820 · Phase 1/2 · completed

The study randomized participants to treatment sequences and used Diastat as an active comparator, but it was open-label and small, with 31 randomized participants. Its primary endpoints were pharmacokinetic measures rather than clinical seizure outcomes, and the registry does not clearly report whether the primary comparison met its prespecified statistical criteria.

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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: Diastat's landscape · Ganaxolone's landscape