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Also known as BXCL501 (180 micrograms)
BXCL501 · 3 trials · 10 indications
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
To assess the safety of 120 mcg BXCL501 when used in an at-home environment based on serious adverse events (SAE) and treatment emergent adverse events (TEAEs).
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Establish the safety of BXCL501 relative to placebo and lofexidine in subjects with OUD who are physically dependent on opioids as measured by the frequency of adverse events.
| Arm | Type | Description |
|---|---|---|
| Part 1: 60 mcg of BXCL501 | EXPERIMENTAL | Sublingual film containing 60 Micrograms Dexmedetomidine |
| Part 1: Matching Placebo | PLACEBO_COMPARATOR | Sublingual Placebo film |
| Part 2: 120 mcg of BXCL501 | EXPERIMENTAL | Sublingual film containing 120 Micrograms Dexmedetomidine |
| Part 2: Matching Placebo | PLACEBO_COMPARATOR | Sublingual Placebo film |
| Cohort 1- 40 Micrograms | EXPERIMENTAL | Sublingual film containing 40 Micrograms Dexmedetomidine |
| Cohort 2- 60 Micrograms | EXPERIMENTAL | Sublingual film containing 60 Micrograms Dexmedetomidine |
| Placebo | PLACEBO_COMPARATOR | Sublingual Placebo film |
| BXCL501 (180 micrograms) | EXPERIMENTAL | The current study is a randomized, double-blind, double-dummy inpatient study comparing BXCL501 (180 and 240 ug BID), lofexidine (as a positive control), and placebo. |
| BXCL501 (240 micrograms) | EXPERIMENTAL | The current study is a randomized, double-blind, double-dummy inpatient study comparing BXCL501 (180 and 240 ug BID), lofexidine (as a positive control), and placebo. |
| Lofexidine (Positive Control) | ACTIVE_COMPARATOR | The current study is a randomized, double-blind, double-dummy inpatient study comparing BXCL501 (180 and 240 ug BID), lofexidine (as a positive control), and placebo. |
| Name | Type | Description |
|---|---|---|
| BXCL501 | DRUG | Sublingual Film |
| Matching Placebo | DRUG | Sublingual Placebo Film |
| BXCL501 (180 micrograms) | DRUG | Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design. |
| BXCL501 (240 micrograms) | DRUG | Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design. |
| Placebo | OTHER | Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design. |
| Lofexidine (Positive Control) | OTHER | Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design. |
A patient may enroll in only one part of the study; either Part 1 or Part 2. Inclusion Criteria: * Male and female patients between the ages of 18 to 75 years, inclusive * Patients who can read, understand and provide written informed consent. * Patients who have met Diagnostic and Statistical Man...
BXCL501 is an investigational small molecule being developed for the treatment of agitation associated with dementia, schizophrenia, and bipolar disorder, as well as for opioid withdrawal. It is a sublingual formulation of dexmedetomidine, currently in Phase 3 clinical trials for agitation indications.
BXCL501 contains dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. By activating these receptors, it is thought to produce sedative and anxiolytic effects without causing respiratory depression, which is why it is being studied for acute agitation and opioid withdrawal.
BXCL501 is being developed by BioXcel Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol BTAI. The company is focused on utilizing artificial intelligence to identify and develop therapies in neuroscience and immuno-oncology.
BXCL501 is in Phase 3 clinical development for agitation associated with schizophrenia, bipolar disorder, and dementia. It has received Breakthrough Therapy and Fast Track designations from the FDA. It is not yet approved and remains investigational.
BXCL501 has been studied in several clinical trials, including NCT05271552 (TRANQUILITY II) for agitation in dementia, NCT05658510 (SERENITY III) for agitation in schizophrenia and bipolar disorder, and NCT05712707 for opioid withdrawal. These trials are completed or active, with a total enrollment of 452 participants.
BXCL501 is a sublingual formulation of dexmedetomidine, a medication already approved intravenously for sedation. BXCL501 is designed for acute treatment of agitation and is being investigated as a potential at-home treatment option.