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# Takeda Soticlestat Studies Miss Primary Endpoints
- URL: https://www.fdaweb.com/takeda-soticlestat-studies-miss-primary-endpoints/
- Published: 2024-06-17T12:00:00.000Z
- Updated: 2026-09-14T14:33:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157194

Takeda says topline data from its SKYLINE and SKYWAY studies of soticlestat (TAK-935) failed to meet their primary endpoints.

The Phase 3 SKYLINE (TAK-935-3001) study evaluated soticlestat plus standard of care versus placebo plus standard of care in patients with refractory Dravet syndrome. “Soticlestat narrowly missed the primary endpoint of reduction from baseline in convulsive seizure frequency as compared to placebo (p-value = 0.06),” the company says. “Among the six key secondary endpoints, soticlestat showed clinically meaningful and nominally significant results in the responder rate, measures of caregiver and clinician global impression of improvement, and seizure intensity and duration scales over the 16-week treatment period (all p-values ≤ 0.008).”

In the Phase 3 SKYWAY (TAK-935-3002) study, soticlestat plus standard of care versus placebo plus standard of care in patients with refractory Lennox-Gastaut syndrome missed the novel primary endpoint of reduction from baseline in “major motor drop seizure frequency” as compared to placebo, according to the company. Soticlestat was generally well tolerated in both studies, it says, and showed a safety profile consistent with previous studies.

Takeda says it will discuss the data with FDA and other regulatory authorities to determine next steps. It will also present the studies’ results at an upcoming scientific meeting.