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IGALMI (BXCL501)

Acute agitation (schizophrenia/bipolar) - At-home use

sNDA ReviewFDA review accepted Apr 2026

Key Facts

Indication
Acute agitation (schizophrenia/bipolar) - At-home use
Phase
sNDA Review
Status
FDA review accepted Apr 2026
Company

About BioXcel Therapeutics

BioXcel Therapeutics' mission is to accelerate and de-risk drug development by applying artificial intelligence to identify new therapeutic applications for existing pharmacologically active compounds. Its primary achievement is the 2022 FDA approval and ongoing commercialization of IGALMI® for acute agitation, with a pivotal near-term catalyst being the FDA's review of a supplemental New Drug Application (sNDA) for at-home use. The company's strategy centers on expanding the label and market reach of its lead asset while advancing its pipeline, including BXCL501 for opioid withdrawal and agitation in Alzheimer's disease, and BXCL701 in immuno-oncology, though its financial position is constrained, necessitating recent capital raises.

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