IGALMI (dexmedetomidine sublingual film) is a BioXcel Therapeutics program in At-home agitation in bipolar disorder or schizophrenia (sNDA). Its PDUFA date is Nov 14, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: At-home agitation in bipolar disorder or schizophrenia (sNDA). Sponsor: BioXcel Therapeutics (BTAI). Market-cap tier at the time we tracked it: Nano. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is IGALMI (dexmedetomidine sublingual film)'s next FDA decision or readout?
IGALMI (dexmedetomidine sublingual film)'s PDUFA date is Nov 14, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at IGALMI (dexmedetomidine sublingual film)'s most recent FDA decision?
No FDA decision for IGALMI (dexmedetomidine sublingual film) is in our archive yet.
What is IGALMI (dexmedetomidine sublingual film) used for?
In our records IGALMI (dexmedetomidine sublingual film) is under review or in development for At-home agitation in bipolar disorder or schizophrenia (sNDA).
Who makes IGALMI (dexmedetomidine sublingual film)?
BioXcel Therapeutics (BTAI).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
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