Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sublingual film containing Dexmedetomidine, Sublingual film containing Dexmedetomidine (BXCL501)
film containing Dexmedetomidine · 3 trials · 9 indications
The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).
The change in PEC score was evaluated at 2 hours following the administration of the BXCL501 60 mcg, and BXCL501 30 mcg (for Part A) and BXCL501 40 mcg (for Part B) versus placebo. PEC is the sum of 5 subscales (poor impulse control, tension, hostility, uncooperativeness, and excitement, each subscale ranging from 1 to 7) and thus ranges from 5 to 35. Change from baseline (pre-dose) PEC total score, with negative values is in favor of improvement.
The safety and tolerability of single doses of BXCL501 was determined in treatment of acute agitation associated with dementia.
| Arm | Type | Description |
|---|---|---|
| 120 Micrograms | EXPERIMENTAL | Sublingual film containing 120 Micrograms Dexmedetomidine |
| 180 Micrograms | EXPERIMENTAL | Sublingual film containing 180 Micrograms Dexmedetomidine |
| Placebo | PLACEBO_COMPARATOR | Sublingual placebo film |
| Cohort 1- 30 Micrograms | ACTIVE_COMPARATOR | Cohort 1 consists of 10 patients out of whom 8 patients receive 30 Micrograms film and the remaining 2 patients receive a placebo |
| Cohort 2- 60 Micrograms | ACTIVE_COMPARATOR | Cohort 2 consists of 10 patients out of whom 8 patients receive 60 Micrograms film and the remaining 2 patients receive a placebo. Additional 20 subjects receive 60 Micrograms or placebo. |
| Cohort 3- 90 Micrograms | ACTIVE_COMPARATOR | Cohort 3 consists of 10 patients out of whom 8 patients receive 90 Micrograms film and the remaining 2 patients receive a placebo |
| Part B Cohort | ACTIVE_COMPARATOR | Part B cohort consists 46 subjects receiving 40 Micrograms or placebo |
| Name | Type | Description |
|---|---|---|
| Sublingual film containing Dexmedetomidine (BXCL501) | DRUG | Sublingual film containing Dexmedetomidine (BXCL501) |
| Placebo Film | DRUG | Placebo Film for BXCL501 |
| Sublingual film containing Dexmedetomidine | DRUG | Sublingual film containing Dexmedetomidine |
| Sublingual Placebo Film | DRUG | Sublingual placebo film that matches BXCL501 |
Inclusion Criteria: 1. Male and female patients between the ages of 18 to 75 years, inclusive. 2. Patients who have met DSM-5 criteria for bipolar I or II disorder. 3. Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse...
It is being developed to treat agitation, including agitation associated with bipolar disorder and psychomotor agitation. The program targets acute agitation in psychiatric and neurological settings, with clinical work spanning bipolar disorder, schizophrenia, and dementia-related agitation.
BioXcel Therapeutics, Inc. (ticker BTAI) is developing the sublingual film containing dexmedetomidine, also known as BXCL501. The company is the sponsor of the clinical program evaluating this small molecule film formulation for agitation-related indications.
The sublingual film containing dexmedetomidine is in Phase 3 development. Phase 3 trials have been completed in agitation associated with bipolar disorder and agitation associated with schizophrenia, while a Phase 1 trial has been completed in agitation associated with dementia.
The program includes completed trials NCT04276883 in agitation associated with bipolar disorder, NCT04268303 in agitation associated with schizophrenia, and NCT04251910 in agitation associated with dementia. The Phase 3 trials each enrolled 380 participants, and the Phase 1 dementia trial enrolled 100 participants.
Yes. BXCL501 is the development code for the sublingual film containing dexmedetomidine. It is also referred to as sublingual dexmedetomidine film, and these names describe the same BioXcel Therapeutics asset.