BioXcel Therapeutics announced that the US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for approval of IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026.

“The regulatory acceptance of our sNDA for IGALMI marks a key milestone in our company’s mission to improve the lives of millions of patients suffering from agitation associated with bipolar disorders or schizophrenia, with no FDA approved treatment option for this condition in the at-home setting. With this progress, our focus is on advancing the commercial strategy and launch plans, tackling up to 86 million annual episodes and addressing a significant unmet need for patients and their caregivers. We look forward to working with the FDA throughout the review process,” said Vimal Mehta, PhD, Chief Executive Officer (CEO), BioXcel Therapeutics.

BioXcel Therapeutics is a biopharmaceutical company built on Artificial Intelligence (AI) to develop transformative medicines in neuroscience.