Biohaven has announced that its experimental drug BHV-7000, also known as opakalim, did not show improvement in depressive symptoms compared to placebo in a Phase II proof-of-concept study for major depressive disorder (MDD). The results were released on December 24. According to the company, there were “trends” favoring the study drug in certain patients with more severe depression at screening, but these findings are considered only hypothesis generating.
The safety profile of BHV-7000 was consistent with earlier studies, showing mostly mild to moderate side effects such as headache and nausea. The drug had a low rate of central nervous system adverse events, which aligns with its mechanism that does not involve GABA activation.
Despite these observations, Biohaven will discontinue development of BHV-7000 for psychiatric disorders. The drug previously failed a Phase II/III trial in bipolar mania. However, the company plans to continue studying the oral therapy for two types of epilepsy and is expected to provide more details at the upcoming J.P. Morgan Healthcare Conference in San Francisco.
Commenting on the outcome, Biohaven stated: “considers the depression subgroup analyses as hypothesis generating.”
Analysts responded cautiously to the news. William Blair described the trial results as disappointing but noted that recent challenges in depression trials made this outcome less surprising due to issues like “clinical trial execution and placebo creep.” Jefferies found the data mixed but not unexpected.
In November 2025, Biohaven reduced its research and development budget by 60% after another setback when its treatment troriluzole for spinocerebellar ataxia was rejected by the FDA. This move is part of a broader cost optimization strategy as both BHV-7000’s epilepsy and depression studies have reached key decision points.
The discontinuation of psychiatric applications for BHV-7000 could benefit Xenon Pharmaceuticals. Xenon is developing XEN1101 (azetukalner), another potassium channel opener that reduced seizures by over 50% after eight weeks in a Phase IIb study. Analysts from Stifel questioned whether BHV-7000 could meet standards set by XEN1101 for focal epilepsy. Xenon expects to release Phase III data on XEN1101 this year.
