NEW HAVEN, Conn. — February 12, 2026 — Leads & Copy — BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced an updated market opportunity assessment for IGALMI® in the at-home setting for acute agitation associated with bipolar disorders or schizophrenia. The assessment, informed by the SERENITY At-Home clinical study results, marks a milestone in the company’s commercial preparation for IGALMI.
The company submitted a supplemental New Drug Application (sNDA) last month to the FDA for at-home use approval of IGALMI for treating agitation related to bipolar disorders or schizophrenia. A comprehensive launch plan is underway.
The commercial opportunity assessment utilized market research based on an updated Target Product Profile derived from the SERENITY At-Home clinical study. It included interviews with 15 prescribers and 5 payers in leadership roles at major health plans, along with survey responses from 180 experienced prescribers. Patient-level claims analyses were used to estimate the number of diagnosed and treated patients who could be candidates for IGALMI.
Prescribers reported a moderate to high unmet need, citing that current treatment options are not indicated for at-home use, may cause sedation, take effect slowly, and/or are controlled substances with dependence potential.
Analyses of market research and claims data identified approximately 2.3 million treated bipolar disorder and schizophrenia patients experiencing frequent episodes of acute agitation at home in the U.S., with up to 1.8 million potentially eligible for IGALMI treatment. This translates to up to 86 million addressable annual episodes that may need treatment, consistent with prior estimates of 57-77 million addressable annual episodes.
Prescribers expressed moderate to high interest in IGALMI for at-home treatment of acute agitation, projecting use in about 70% of their schizophrenia and bipolar disorder patients, regardless of agitation severity. IGALMI is anticipated to be used alone or with existing off-label treatments, frequently replacing benzodiazepines. Payers indicated expectations for broad formulary coverage with standard adjudication controls.
Patient and caregiver research (N=80) previously indicated that patients with schizophrenia and bipolar disorder would expect to use IGALMI in approximately 80% of their acute agitation episodes.
Mark Pavao, Interim Chief Commercial Officer of BioXcel Therapeutics, stated that the assessment validates IGALMI’s commercial opportunity in the at-home setting and reinforces confidence in launch planning.
The company also conducted an interview with patient advocate Gabe Howard, who shared his experience with acute agitation episodes due to bipolar disorder and the need for at-home therapy.
The market opportunity assessment is augmented by prior company-sponsored Key Opinion Leader (KOL) initiatives, including a virtual expert roundtable on emerging approaches for acute agitation (December 8, 2025) and a live webcast and Q&A session on clinical data from the SERENITY At-Home trial (September 10, 2025).
IGALMI® (dexmedetomidine) sublingual film is a prescription medicine used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults, administered under the supervision of a healthcare provider.
Outside of its approved indication as IGALMI®, BXCL501, an investigational proprietary, orally dissolving film formulation of dexmedetomidine, is under investigation for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence.
Source: BioXcel Therapeutics, Inc.
