BioXcel Completes Market Opportunity Assessment for At-Home IGALMI Use
BioXcel completed a market assessment for at-home IGALMI use, finding strong prescriber and payer interest. The company submitted an sNDA for at-home use in acute agitation associated with bipolar disorders or schizophrenia.
On Feb. 12, 2026, BioXcel Therapeutics announced the completion of an updated market opportunity assessment for IGALMI (dexmedetomidine) sublingual film for acute agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting. The assessment, informed by results from the SERENITY At-Home clinical study, is intended to inform launch planning activities. The company submitted a supplemental New Drug Application (sNDA) last month seeking FDA approval of IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia.
The third-party commercial assessment showed a larger than expected potential total addressable market for IGALMI in the at-home setting, along with strong prescriber interest, patient demand, and positive payer feedback on potential formulary coverage. The assessment was based on market research leveraging an updated Target Product Profile, incorporating interviews with 15 prescribers and 5 payers with leadership responsibility at large health plans, as well as survey responses from 180 prescribers with extensive relevant experience. Patient-level claims analyses were used to estimate the number of diagnosed and treated patients who may be candidates for IGALMI.
“This assessment further validates IGALMI’s commercial opportunity in the at-home setting,” said the Interim Chief Commercial Officer of BioXcel Therapeutics. “The strong prescriber and patient interest, as well as positive payer feedback on potential formulary coverage, reinforce our confidence in launch planning and represent a critical step as we advance our commercial strategy.”
A comprehensive launch plan for IGALMI in the at-home setting is in development. The company also conducted an interview with a patient advocate who struggles with acute agitation episodes due to underlying bipolar disorder, highlighting the high unmet need for a therapy in the at-home setting. The updated market opportunity assessment is further augmented by a series of prior Company-sponsored Key Opinion Leader initiatives.
IGALMI is a prescription medicine, administered under the supervision of a health care provider, placed under the tongue or behind the lower lip, used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose, and it is not known if IGALMI is safe and effective in children. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.