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BXCL501 80 Micrograms · 1 trial · 5 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)
| Arm | Type | Description |
|---|---|---|
| 80 Micrograms | EXPERIMENTAL | Sublingual film containing 80 micrograms Dexmedetomidine |
| 120 Micrograms | EXPERIMENTAL | Sublingual film containing 120 micrograms Dexmedetomidine |
| Placebo | PLACEBO_COMPARATOR | Sublingual Placebo film |
| 60 Micrograms | EXPERIMENTAL | Sublingual film containing 60 micrograms Dexmedetomidine Europe Only |
| Name | Type | Description |
|---|---|---|
| BXCL501 80 Micrograms | DRUG | Sublingual film containing 80 Micrograms BXCL501 |
| Placebo Film | DRUG | Matching Sublingual Placebo film |
| BXCL501 120 Micrograms | DRUG | Sublingual film containing 120 Micrograms BXCL501 |
| BXCL501 60 Micrograms | DRUG | Sublingual film containing 60 Micrograms BXCL501 Europe Only |
Inclusion Criteria: 1. Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria). 2. Patients who are judged to be clinically agitated at Screening and Baseline with a total...
BXCL501 80 Micrograms is an investigational small molecule being developed for the treatment of agitation associated with schizophrenia and bipolar disorder. It is currently in Phase 1 clinical development for these psychiatric conditions.
The specific molecular target of BXCL501 80 Micrograms is not disclosed in the available information. The drug is being studied for its efficacy and safety in managing agitation in patients with schizophrenia and related disorders.
BXCL501 80 Micrograms is being developed by BioXcel Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol BTAI. The company is conducting clinical trials to evaluate the drug's potential in psychiatric indications.
BXCL501 80 Micrograms is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Breakthrough Therapy and Fast Track designations from the FDA for its studied indications.
BXCL501 80 Micrograms is being studied in a Phase 1 clinical trial with the identifier NCT05025605. This randomized, double-blind, placebo-controlled trial is evaluating the drug's efficacy and safety in treating agitation associated with pediatric schizophrenia and bipolar disorder, with an enrollment of 140 participants.
BXCL501 80 Micrograms is a specific dosage strength of the investigational drug BXCL501. The clinical trial NCT05025605 is studying this dosage form for its effects on agitation in patients with schizophrenia and bipolar disorder.