Organization (Industry)
BioXcel Therapeutics, Inc.
ClinicalTrials.gov lists BioXcel Therapeutics, Inc. as lead sponsor of 15 trials. It has 35 active development programs and 2 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 2.2 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers BioXcel Therapeutics, Inc.: 15 lead-sponsored trials and 3 legal-entity registrations.
Disease areas (14)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Psychomotor Agitation | 14 |
| Schizophrenia | 7 |
| Bipolar Disorder | 6 |
| Psychotic Disorders | 6 |
| Dementia | 4 |
Showing 5 of 14 disease areas.
Trials by start year as sponsor or collaborator (6)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2025 | 2 |
| 2023 | 4 |
| 2022 | 4 |
| 2021 | 3 |
| 2020 | 4 |
| 2019 | 4 |
Recruitment duration, a model prediction: none of the 15 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (35)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| BXCL501 | Psychomotor Agitation | Phase 3 | 5 |
| BXCL501 | Dementia | Phase 3 | 3 |
| Sublingual film containing Dexmedetomidine | Psychomotor Agitation | Phase 3 | 3 |
| BXCL501 | Bipolar Disorder | Phase 3 | 1 |
| BXCL501 | Psychotic Disorders | Phase 3 | 1 |
Showing 5 of 35 active programs.
Approved assets (2)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Sublingual film containing Igalmi | 1 |
| DEXMEDETOMIDINE | 1 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 69% hit target (n=13) | 33% on time (n=12) |
Journals published in (14)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| The western journal of emergency medicine | 3 |
| Journal of clinical anesthesia | 2 |
| Advances in therapy | 1 |
| BMC psychiatry | 1 |
| Clinical practice and epidemiology in mental health : CP & EMH | 1 |
Showing 5 of 14 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 17 | 16 | 2025-07-22 |
SEC-reported annual financials (9)
Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.
| Fiscal year | Revenue (USD) | Net income (USD) | R&D (USD) |
|---|---|---|---|
| 2025 | 642,000 | -69,897,000 | 30,251,000 |
| 2024 | 2,266,000 | -59,599,000 | 30,435,000 |
| 2023 | 1,380,000 | -179,053,000 | 84,326,000 |
| 2022 | 375,000 | -165,757,000 | 91,239,000 |
| 2021 | not reported | -106,931,000 | 52,708,000 |
| 2020 | not reported | -82,169,000 | 57,995,000 |
| 2019 | not reported | -32,968,000 | 25,797,000 |
| 2018 | not reported | -19,270,000 | 14,558,000 |
| 2017 | not reported | -4,539,000 | 2,690,000 |
Financing and grant events (59)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2026-07-31 | Debt financing | not disclosed | Sec extracted |
| 2026-07-03 | Debt financing | not disclosed | Sec extracted |
| 2026-04-15 | Debt financing | not disclosed | Sec extracted |
| 2026-03-11 | Other financing | not disclosed | Edgar offerings |
| 2026-03-11 | Registered direct | 7,800,000 | Sec extracted |
Showing 5 of 59 events.
Climate targets, as filed (1)
| Reporting year | Net-zero target |
|---|---|
| 2025 | not disclosed |
Workforce and board diversity, as filed (1)
| Reporting year | Workforce % women | Board % women |
|---|---|---|
| 2025 | not disclosed | not disclosed |
Organization relationships (4)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Iqvia Holdings Inc. | Co sponsors trial with | 1 |
| Iqvia Holdings Inc. | Uses vendor | 1 |
| Worldwide Clinical Trials (United States) | Uses vendor | 1 |
| Premier Research | Uses vendor | 1 |
Latest dated events (116)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-11-14 | PDUFA decision date | Regulatory decision dates extracted from SEC filings |
| 2026-07-31 | Debt facility | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-07-03 | Debt facility | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-04-15 | Debt facility | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-03-11 | Registered direct offering | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
Showing 5 of 116 events.
Biomarker capability evidence (42)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ALB | Trial sponsor | Named in trial inclusion criteria |
| GNRH1 | Trial sponsor | Named in trial inclusion criteria |
| CTLA4 | Trial sponsor | Named in trial exclusion criteria |
| CTLA4 | Trial collaborator | Named in trial exclusion criteria |
| DPP4 | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 42 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, fda warning letters, fda untitled letters, fda inspection record, fda recalls, fda import refusals, manufacturing and distribution sites, clia clinical laboratory certificates, and biomarkers this organization publishes on.