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Also known as Sublingual film containing BXCL501 (Dexmedetomidine)
film containing BXCL501 · 1 trial · 2 indications
Positive and Negative Syndrome Scale - Excited Component (PEC). The 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 to 35.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Sublingual Film with no active drug; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy |
| 20 micrograms | EXPERIMENTAL | Sublingual Film containing 20 micrograms BXCL501; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy |
| 60 micrograms | EXPERIMENTAL | Sublingual Film containing 60 micrograms BXCL501; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy |
| 120 micrograms | EXPERIMENTAL | 2 Sublingual Films, each containing 60 micrograms BXCL501; single administration of 2 films with the possibility of repeating dose after 1 hour in case of lack of significant efficacy |
| 180 micrograms | EXPERIMENTAL | 2 Sublingual Films, each containing 60 micrograms BXCL501. |
| Name | Type | Description |
|---|---|---|
| Sublingual film containing BXCL501 (Dexmedetomidine) | DRUG | Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia |
| Placebo film | DRUG | Placebo film for BXCL501 |
Inclusion Criteria: 1. Male and female patients between the ages of 18 to 65 years, inclusive. 2. Patients who have met Diagnostic and Statistical Manual (DSM) -5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder. 3. Patients who are judged to be clinically agitated at Basel...
The sublingual film containing BXCL501 is an investigational small-molecule product being developed by BioXcel Therapeutics, Inc. for agitation. It is a film dosage form placed under the tongue, and it is also referred to as sublingual film containing dexmedetomidine. It is in Phase 1 clinical development.
The sublingual film containing BXCL501 is being developed for agitation, including agitation associated with schizophrenia. Its completed Phase 1 trial enrolled adults with agitation and schizophrenia. The product remains investigational and is not established as a marketed treatment.
BioXcel Therapeutics, Inc. is developing the sublingual film containing BXCL501. The company trades under the ticker BTAIQ. The program sits in the company's psychiatry therapeutic area and uses a small-molecule modality in a sublingual film format.
The sublingual film containing BXCL501 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program is investigational and still in clinical development.
The sublingual film containing BXCL501 has been studied in trial NCT04010305, titled Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia. The Phase 1 trial was completed in the United States with 135 enrolled participants, ages 18 and older, and used a randomized, double-blind, placebo-controlled design.
The sublingual film containing BXCL501 is also known as sublingual film containing dexmedetomidine, so searches for that name refer to the same BioXcel Therapeutics product. BXCL501 is the company's designation for this sublingual film formulation being developed for agitation.