Bioxcel Therapeutics (BX20) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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 | ― |
| 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 | ― |
| 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 | ― |
| Bxcl701 Plus Pembrolizumab, Bxcl701 Monotherapy | Prostate Cancer, Neuroendocrine Tumors, Small Cell Carcinoma | phase1AndPhase2 | Completed | A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype. | Jan 04, 2019 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Bxcl501 Sublingual Film | Phase II | Schizophrenia, Bipolar I Disorder, Schizoaffective Disorder, Bipolar Ii Disorder, Schizophreniform Disorders, Psychomotor Agitation | Active Not Recruiting | Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder | Jul 07, 2025 | ― |
| Bxcl501 | Phase III | Schizophrenia, Bipolar I Disorder, Schizoaffective Disorder, Bipolar Ii Disorder, Schizophreniform Disorders, Agitation,Psychomotor | Completed | Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) | Dec 12, 2022 | ― |
| Bxcl501 80 Micrograms, Bxcl501 120 Micrograms, Bxcl501 60 Micrograms | Phase I | Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder Ii | Recruiting | Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder | Aug 24, 2021 | ― |
| Bxcl701 Plus Pembrolizumab, Bxcl701 Monotherapy | phase1AndPhase2 | Prostate Cancer, Neuroendocrine Tumors, Small Cell Carcinoma | Completed | A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype. | Jan 04, 2019 | ― |
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
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 (DE:BX20) have in its pipeline
Bioxcel Therapeutics DE:BX20 is currently developing the following drugs: Bxcl501 Sublingual Film, Bxcl501, Bxcl501 80 Micrograms, Bxcl501 120 Micrograms, Bxcl501 60 Micrograms, Bxcl701 Plus Pembrolizumab, Bxcl701 Monotherapy. These drug candidates are in various stages of clinical development as the company works toward FDA approval.