On February 12, 2026, BioXcel Therapeutics, Inc. (the "Company") announced the completion of an updated market opportunity assessment for IGALMI® for acute agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting, informed by results from the SERENITY At-Home clinical study. The Company submitted a supplemental New Drug Application (sNDA) last month seeking the FDA's approval of IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia.
The commercial opportunity assessment was based on recently completed market research leveraging an updated Target Product Profile based on results from the SERENITY At-Home clinical study. The assessment incorporated 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. In addition, patient-level claims analyses were used to estimate the number of diagnosed and treated patients who may be candidates for IGALMI.
Current agitation landscape insights from the assessment included:
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Prescribers reported a moderate to high unmet need, noting that current treatment options are not indicated for at-home use, may be sedating, are slow to take effect, and/or are controlled substances with the potential to cause dependence.
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Analyses of market research and claims data identified approximately 2.3 million treated bipolar disorder and schizophrenia patients experiencing frequent episodes of acute agitation in the at-home setting in the United States, of whom up to 1.8 million may be eligible for IGALMI treatment. This represents up to 86 million addressable annual episodes that may require treatment. This updated estimate is generally consistent with prior estimates of approximately 57-77 million addressable annual episodes, with further refinement based on the additional insights from market research.
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IGALMI opportunity in the at-home setting based on the assessment included:
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Prescribers reported moderate to high interest in IGALMI for the treatment of acute agitation in the at-home setting, projecting use in approximately 70% of their schizophrenia and bipolar disorder patients, regardless of agitation severity.
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Prescribers anticipated that IGALMI would be used either alone or in combination with existing off-label treatments for acute agitation, and that IGALMI would most frequently replace benzodiazepines, which may cause dependence.
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Payers indicated expectations for broad formulary coverage with standard adjudication controls.
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Previously reported patient and caregiver research (N=80) indicated that patients with schizophrenia and bipolar disorder would expect to use IGALMI in approximately 80% of their acute agitation episodes.
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