The major depressive disorder failure for BHV-7000 is the drug’s second, after Biohaven’s spinocerebellar ataxia treatment troriluzole was rejected by the FDA in November 2025.
Biohaven has recorded another failure for the potassium channel agonist BHV-7000 in major depressive disorder, leading the company to move on from psychiatric disorder applications for the drug.
BHV-7000, also known as opakalim, did not improve depressive symptoms in patients with MDD after six weeks as compared to placebo during a Phase II proof-of-concept study, according to a December 24 press release. Biohaven reported “trends” that favored the study drug, including improvements on the primary and some secondary outcomes in patients who had more severe depression at screening.
As for safety, Biohaven reported mild to moderate adverse events, primarily headache and nausea. The drug showed a low incidence of central nervous system adverse events, which was expected given BHV-7000’s lack of GABA activation. The safety results were consistent with previous studies.
Biohaven “considers the depression subgroup analyses as hypothesis generating,” according to the release. But the company will not move forward with any more psychiatric indications for the drug. BHV-7000 previously failed a Phase II/III bipolar mania trial.
But the oral therapy will continue on in two forms of epilepsy. Company management will provide a more thorough update on the year ahead at the upcoming J.P. Morgan Healthcare Conference in San Francisco.
William Blair called the trial results disappointing, but had previously expressed caution heading into the study given recent challenges in depression trials with “clinical trial execution and placebo creep.” Jefferies called the data mixed but was unsurprised by the outcome.
Biohaven is currently undergoing a significant cost optimization push to maximize resources. The company slashed its R&D budget by 60% in November 2025 after the spinocerebellar ataxia treatment troriluzole was rejected by the FDA. BHV-7000’s epilepsy and depression readouts also came into clearer focus at that time.
The failure removes an overhang for Xenon Pharmaceuticals, which is similarly developing a potassium channel opener called XEN1101, or azetukalner, according to analysts. Stifel expressed sekpticism that BHV-7000 can meet the high bar set by Xenon’s asset in focal epilepsy.
XEN1101 reduced seizures by more than 50% after eight weeks of treatment in a Phase IIb study. Xenon is expected to report Phase III data for the asset in focal epilepsy this year.
