Data Readout

Biohaven's opakalim epilepsy trial nears H2 2026 readout after two delays

RISE 3 has pushed its primary completion date twice since 2024, and Biohaven now points to second-half 2026 pivotal data testing a Kv7 activator with no direct approved comparator.

By AppliedXLJuly 13, 2026Trial NCT06309966

Executive Summary

Biohaven is heading toward its first pivotal readout for a selective Kv7 channel activator in refractory focal epilepsy, a mechanism with no approved comparator in the indication.
Open-label extension data already reported seizure reductions of 50% or more in most six-month completers, meaning the pivotal, placebo-controlled result needs to reproduce that signal under randomization to be read as confirmatory rather than a step down.
The trial's primary completion date has moved twice since the study began, most recently landing three months before the current guided readout window opens, a pattern that has already stretched the timeline once before.
The focal epilepsy field is active with several late-stage entrants pursuing different mechanisms, but none share opakalim's ion-channel target, leaving no head-to-head benchmark for the pivotal result.

The catalyst

Biohaven said it expects initial pivotal topline results for opakalim in focal epilepsy in the second half of 2026, per its March 2026 business update. The catalyst attaches to NCT06309966, known as RISE 3, a Phase 2/3, randomized, placebo-controlled study testing BHV-7000 against placebo in adults with drug-resistant focal onset epilepsy. The trial's primary endpoint is change from baseline in 28-day average seizure frequency, measured against a placebo comparator across three treatment arms. Biohaven+1

Probability of Success

Endpoint Met86%

Completes81%

Clinical Significance50%

Regulatory60%

What the OLE already showed

Biohaven disclosed that in an ongoing open-label extension of the same program, the majority of participants completing at least six months on opakalim 75 mg once daily showed seizure-frequency reductions of 50% or more from pretreatment baseline, with a low incidence of central nervous system adverse events. That open-label signal, without a placebo arm, sets an informal bar: the placebo-controlled RISE 3 result will show whether the effect holds once randomization and blinding are in place. Biohaven

The timing pattern

RISE 3's registered primary completion date has moved twice: from August 2025 to January 2026 in August 2025, then to May 2026 in November 2025, a cumulative delay of 273 days. The trial remains listed as Recruiting with an anticipated enrollment of 390 patients, unchanged from its original target, which the operational model treats as a routine enrollment level rather than a cut. The guided readout window itself has also shifted across four company updates since January 2025, moving from first-half 2026 to second-half 2026 in the most recent guidance. NCT06309966+1

The competitive frame

Focal epilepsy has an active late-stage field, including Rapport Therapeutics' RAP-219 and UCB's brivaracetam, both in Phase 3, but neither shares opakalim's Kv7 channel target. No trial in the indication or target landscape currently qualifies as a direct comparator to opakalim's mechanism. With no validated disease-modifying ion-channel mechanism established in this refractory population, a placebo-adjusted seizure reduction that reproduces the open-label extension's magnitude under blinded conditions, and holds with tolerable central nervous system effects, would be the result that distinguishes RISE 3 from the rest of the field.

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