BioXcel Therapeutics submits sNDA to U.S. FDA for Igalmi

BioXcel Therapeutics (BTAI) announced it submitted a supplemental New Drug Application, sNDA, to the U.S. Food and Drug Administration, FDA, for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting with Igalmi. The sNDA was submitted on January 14, 2026. “We are pleased with the successful submission of this sNDA for IGALMI, which represents an important milestone in expanding access to patients who are experiencing acute agitation episodes in the at-home setting,” said Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics. “The submission is supported by results from the Phase 3 SERENITY At-Home safety trial, fulfilling a clear unmet medical need in the at-home setting where agitation often originates. This supports the Company’s mission of driving a broader and more convenient access to a critical treatment option across care-settings.”