$0.83
+0.04 (+4.46%)
USD · as of 2026-08-19 · marketstack
Clinical trials
catalyst calendar across sponsors →Studies where BTAI is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
15 interventional · 7 with posted results
Held by 4 tracked-famous managers (MILLENNIUM MANAGEMENT LLC, OAKTREE CAPITAL MANAGEMENT LP, CITADEL ADVISORS LLC, SUSQUEHANNA INTERNATIONAL GROUP, LLP) · FINRA short interest 9.7 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar DisorderNCT05025605Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total scoreRandomized · Double-masked · Treatment | Phase 1 | Recruiting | Drug: BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 Micrograms | Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II | 140 | 2027-07-31 | in 345 d | 2026-08-11 |
| Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar DisorderNCT07116694Informant and Clinician ratings comparisonOpen-label · Treatment | Phase 2 | Completed | Drug: BXCL501 Sublingual Film | Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Psychomotor Agitation | 33 | 2025-10-07actual | — | 2026-08-06 |
| Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)NCT05658510Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total scoreRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: BXCL501, Matching Placebo | Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders | 452 | 2025-08-15actual | — | 2026-08-07 |
| Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar DisorderNCT06041646results2026-01-02Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total ScoreOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Sublingual film containing Igalmi | Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder, Schizophreniform Disorders | 29 | 2024-04-29actual | — | 2026-08-11 |
| A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype.NCT03910660Phase 2a: Estimate the composite response rate of the combination of BXCL701 + PEMBRORandomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: BXCL701 plus Pembrolizumab, BXCL701 monotherapy | Prostate Cancer, Neuroendocrine Tumors, Small Cell Carcinoma | 98 | 2023-10-31actual | — | 2026-05-15 |
| Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)NCT05665088Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total scoreRandomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Study was terminated for business reasons; not due to safety or efficacy concerns | Drug: BXCL501, Matching Placebo | Agitation, Dementia | 13 | 2023-09-11actual | — | 2023-12-11 |
| Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)NCT05271552results2025-12-31Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of AgitationRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: BXCL501, Matching Placebo | Agitation, Dementia | 151 | 2023-04-21actual | — | 2026-08-11 |
| An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With DementiaNCT05276830results2023-08-25Change in Positive and Negative Syndrome Scale- Excited Component (PEC) Total ScoreRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Study was terminated for business reasons; not due to safety or efficacy concerns | Drug: BXCL501, BXCL501, Placebo film | Agitation, Dementia | 5 | 2022-04-01actual | — | 2026-08-11 |
| Study of BXCL501 In Agitation Associated With Delirium in ICU PatientsNCT053133862-point or greater drop in RASSRandomized · Quadruple-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: The study stopped early, before enrolling its first participant | Drug: BXCL501, Placebo film | Agitation, Delirium | 0 | 2022-02-21 | — | 2026-08-11 |
| Sub-Lingual Dexmedetomidine in Agitation Associated With DementiaNCT04251910results2023-09-21Mean Change From Baseline in Positive and Negative Syndrome Scale-Excited Component (PEC) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Sublingual film containing Dexmedetomidine, Sublingual Placebo Film | Agitation,Psychomotor, Dementia | 100 | 2022-01-24actual | — | 2026-08-11 |
| A Pilot Study of BXCL701 in Patients With Pancreatic CancerNCT04123574To characterize the quantitative and qualitative effects of BXCL701 on relevant immune effector cytokines and various immunological effector cells that are consistent with its known mechanism of action.Open-label · Treatment | Early Phase 1 | Withdrawnsponsor's stated reason: No longer relevant to field | Drug: Talabostat Mesylate | Cancer of Pancreas, Cancer of the Pancreas, Neoplasms, Pancreatic, Pancreas Cancer, Pancreatic Cancer | 0 | 2021-12-06 | — | 2026-08-11 |
| Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid WithdrawalNCT04470050results2023-10-26Peak SOWS Scores at Baseline and Over TimeRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Dexmedetomidine, Placebo | Opioid Withdrawal | 225 | 2021-02-18actual | — | 2026-08-11 |
| Dexmedetomidine in the Treatment of Agitation Associated With Bipolar DisorderNCT04276883results2023-09-11Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Sublingual film containing Dexmedetomidine (BXCL501), Placebo Film | Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder | 380 | 2020-05-21actual | — | 2026-08-11 |
| Dexmedetomidine in the Treatment of Agitation Associated With SchizophreniaNCT04268303results2023-06-18Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Sublingual film containing dexmedetomidine (BXCL501), Placebo Film | Agitation, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder, Schizophreniform Disorders | 380 | 2020-05-06actual | — | 2026-08-11 |
| Sub-Lingual Dexmedetomidine in Agitation Associated With SchizophreniaNCT04010305PANSS-EC Change From BaselineRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Sublingual film containing BXCL501 (Dexmedetomidine), Placebo film | Agitation, Schizophrenia | 135 | 2019-07-31actual | — | 2026-08-11 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19