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Bioxcel Therapeutics Inc (BTAI)
NASDAQ:BTAI
Bxcl501 Sublingual Film
Schizophrenia, Bipolar I Disorder, Schizoaffective Disorder, Bipolar Ii Disorder, Schizophreniform Disorders, Psychomotor Agitation
Phase II
Active Not Recruiting
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
Jul 07, 2025
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Bxcl501
Schizophrenia, Bipolar I Disorder, Schizoaffective Disorder, Bipolar Ii Disorder, Schizophreniform Disorders, Agitation,Psychomotor
Phase III
Completed
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
Dec 12, 2022
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Bxcl501 80 Micrograms, Bxcl501 120 Micrograms, Bxcl501 60 Micrograms
Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder Ii
Phase I
Recruiting
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Aug 24, 2021
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Bxcl701 Plus Pembrolizumab, Bxcl701 Monotherapy
Prostate Cancer, Neuroendocrine Tumors, Small Cell Carcinoma
Phase I/II
Completed
A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype.
Jan 04, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Bioxcel Therapeutics Inc (BTAI) have in its pipeline
BTAI is currently developing the following drugs: Bxcl501 Sublingual Film, Bxcl501, Bxcl501 80 Micrograms, Bxcl501 120 Micrograms, Bxcl501 60 Micrograms. These drug candidates are in various stages of clinical development as the company works toward FDA approval.