Developer · BTAI · United States

BioXcel Therapeutics, Inc.

A clinical-stage biopharmaceutical company using artificial intelligence to develop neuroscience medicines; its lead product IGALMI (dexmedetomidine sublingual film, developed as BXCL501) is FDA-approved for acute agitation in schizophrenia and bipolar disorder. As of mid-2026 the company remains independent and is exploring strategic options.

bioxceltherapeutics.com ↗

1compound

4programs

4indications

Filed (NDA)lead asset

Phase distribution

Filed (NDA)1
Phase 31
Phase 21
Phase 1/21

Modality

Small molecule 1

Mechanism focus

alpha-2A adrenoceptor 1

Pipeline (1)

Dexmedetomidine sublingual film (BXCL501)Small moleculealpha-2A adrenoceptor Agonist
- Agitation in Alzheimer's diseasePhase 3Active
- SchizophreniaFiled (NDA)Active
- Acute Stress DisorderPhase 2Recruiting
- Opioid use disorderPhase 1/2Active

Deals & partnerships

Dexmedetomidine sublingual film (BXCL501)Partner Oaktree Capital Management, L.P.Partner Qatar Investment Authority

Apr 19, 2022PartnershipBioXcel secures up to $260M strategic financing from Oaktree and Qatar Investment Authority for IGALMI / BXCL501Up to $260M in gross funding to support commercial activities for IGALMI (dexmedetomidine sublingual film) and expansion of BXCL501 clinical development, including the pivotal Phase 3 program in agitation associated with Alzheimer's disease. Structure: up to $135M delayed draw term loan, up to $120M capped revenue interest (royalty) on net sales of IGALMI and future BXCL501 products, and up to $5M equity investment.Dexmedetomidine sublingual film (BXCL501)source ↗

Catalysts · 4 upcoming · 3 reported

2H 2026Anticipated
Dexmedetomidine sublingual film (BXCL501)forAcute Stress DisorderTopline data
Phase 2a RISE study of sublingual dexmedetomidine (BXCL501) in acute stress reactions after motor vehicle collision: topline expected after the estimated Sep 2026 primary completion.
NCT06943404 source ↗
PDUFA 14 Nov 2026Anticipated
Dexmedetomidine sublingual film (BXCL501)forSchizophreniaRegulatory
FDA decision (PDUFA) on the sNDA to expand IGALMI (BXCL501) to at-home use for acute agitation in bipolar disorders or schizophrenia expected 14 Nov 2026.
source ↗
Date TBDAnticipated
Dexmedetomidine sublingual film (BXCL501)forAgitation in Alzheimer's diseaseTopline data
Confirmatory TRANQUILITY In-Care Phase 3 (~150 patients, 60 mcg PRN, care setting) planned but not yet started as of Q1 2026.
source ↗
Date TBDAnticipated
Dexmedetomidine sublingual film (BXCL501)forOpioid use disorderTopline data
Larger confirmatory trial of BXCL501 in opioid withdrawal anticipated but not designed/scheduled as of Mar 2026.
source ↗

Recently reported

2026-03-05met
Dexmedetomidine sublingual film (BXCL501)forOpioid use disorderTopline data
Investigator-sponsored Phase 1/2 (NCT05712707) topline: BXCL501 240 ug BID reduced opioid-withdrawal symptoms vs placebo (>30% SOWS-Gossop reduction) and numerically beat lofexidine with fewer adverse events.
source ↗
2025-08-27met
Dexmedetomidine sublingual film (BXCL501)forSchizophreniaTopline data
SERENITY At-Home (NCT05658510 Part 2) Phase 3 safety trial MET its primary endpoint: at-home 120 mcg sublingual dexmedetomidine well tolerated across 2,437 agitation episodes, supporting the sNDA.
source ↗
2023-06-29met
Dexmedetomidine sublingual film (BXCL501)forAgitation in Alzheimer's diseaseTopline data
TRANQUILITY II Phase 3 met its primary endpoint: 60 mcg sublingual dexmedetomidine cut PEC by 7.5 points at 2h vs 5.4 placebo (p=0.0112).
source ↗

Recent activity

May 15, 2026Phase changeDexmedetomidine sublingual film (BXCL501)·Agitation in Alzheimer's diseasePhase 3Q1-2026 business update: BXCL501 remains in Phase 3 development for agitation in Alzheimer's dementia; the TRANQUILITY In-Care pivotal trial had not yet started (CRO selection / protocol finalization). Company disclosed substantial doubt about going concern ($17.2M cash at 31 Mar 2026).source ↗
Apr 8, 2026Phase changeDexmedetomidine sublingual film (BXCL501)·Acute Stress DisorderPhase 2BioXcel announced enrollment of the first patients in the Department of War-funded Phase 2a study of BXCL501 for acute stress reactions, led by the UNC Institute for Trauma Recovery; the study evaluates reduction of ASR symptom severity, neurocognitive function, and prevention of progression to chronic posttraumatic neuropsychiatric symptoms.source ↗
Apr 1, 2026Phase changeDexmedetomidine sublingual film (BXCL501)·SchizophreniaFiled (NDA)FDA ACCEPTED the sNDA for IGALMI at-home use; PDUFA target action date set for 14 Nov 2026. If approved, would be the first FDA-approved at-home acute treatment for agitation associated with bipolar disorders or schizophrenia.source ↗
Mar 5, 2026ReadoutDexmedetomidine sublingual film (BXCL501)·Opioid use disordermetInvestigator-sponsored Phase 1/2 (NCT05712707) topline: BXCL501 240 ug BID reduced opioid-withdrawal symptoms vs placebo (>30% SOWS-Gossop reduction) and numerically beat lofexidine with fewer adverse events.source ↗
Feb 23, 2026Phase changeDexmedetomidine sublingual film (BXCL501)·Acute Stress DisorderPhase 2Phase 2a RISE trial (NCT06943404), sponsored by University of North Carolina, Chapel Hill, started (actual study start date 2026-02-23). Randomized, double-blind, placebo-controlled study of sublingual dexmedetomidine vs placebo in adults with acute stress reactions after a motor vehicle collision; primary endpoint = change in ASDS at Week 1 and Week 3.source ↗
Jan 14, 2026Phase changeDexmedetomidine sublingual film (BXCL501)·SchizophreniaFiled (NDA)BioXcel SUBMITTED the sNDA to the FDA for IGALMI label expansion to at-home use for acute agitation associated with bipolar disorders or schizophrenia, supported by the SERENITY At-Home (Part 2) safety trial.source ↗
Aug 27, 2025ReadoutDexmedetomidine sublingual film (BXCL501)·SchizophreniametSERENITY At-Home (NCT05658510 Part 2) Phase 3 safety trial MET its primary endpoint: at-home 120 mcg sublingual dexmedetomidine well tolerated across 2,437 agitation episodes, supporting the sNDA.source ↗
Aug 18, 2025Phase changeDexmedetomidine sublingual film (BXCL501)·SchizophreniaPhase 3Positive FDA pre-sNDA meeting: FDA aligned with BioXcel that the planned sNDA regulatory package (content, format, clinical/nonclinical data, CMC) is sufficient to support submission for at-home use of IGALMI in bipolar/schizophrenia agitation.source ↗
Jun 30, 2025Phase changeDexmedetomidine sublingual film (BXCL501)·Opioid use disorderPhase 1/2NCT05712707 reached its actual primary completion date (2025-06-30); study status ACTIVE_NOT_RECRUITING.source ↗
Oct 15, 2024Phase changeDexmedetomidine sublingual film (BXCL501)·Acute Stress DisorderPhase 2BioXcel announced a $2.8M U.S. Department of Defense grant to the UNC Institute for Trauma Recovery (Sept 15 2024 - Sept 14 2026, PI Samuel McLean MD MPH) to fund a double-blind, placebo-controlled study of BXCL501 (sublingual dexmedetomidine) for acute stress disorder, targeting ~100 patients with ASD from motor vehicle collisions, with enrollment expected to begin in 1H 2025.source ↗
Apr 10, 2024Phase changeDexmedetomidine sublingual film (BXCL501)·Agitation in Alzheimer's diseasePhase 3BioXcel announced the design of a single confirmatory TRANQUILITY In-Care pivotal Phase 3 (~150 patients in care settings, 60 mcg PRN over 12 weeks; PEC at 2h primary) for agitation associated with Alzheimer's dementia; the earlier TRANQUILITY III (NCT05665088) and BXCL501-203 (NCT05276830) PRN studies had been terminated for business reasons.source ↗
Jun 29, 2023ReadoutDexmedetomidine sublingual film (BXCL501)·Agitation in Alzheimer's diseasemetTRANQUILITY II Phase 3 met its primary endpoint: 60 mcg sublingual dexmedetomidine cut PEC by 7.5 points at 2h vs 5.4 placebo (p=0.0112).source ↗

Trials recruiting · 1 recruiting of 7 sponsored

Phase 2Dexmedetomidine sublingual film (BXCL501)n=1003 sites · United States
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With a Sublingual Formulation of Dexmedetomidine (BXCL501)
Acute Stress ReactionAcute Stress DisorderPost-traumatic Stress DisorderNCT06943404 ↗