BXCL501

Phase 2Small molecule

BBioXcel Therapeutics Inc

BXCL501 is one of 10 small molecule programs targeting Opioid Withdrawal. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Opioid WithdrawalActive, not recruiting

RecoveryNot yet recruiting

Opioid WithdrawalPhase 2

Active, not recruiting

RecoveryPhase 2

Not yet recruiting

Competition

Competitive Landscape

12 competitors in Recovery

#DrugCompanyPhaseTrials

Neurontin

VViatris Specialty LLC

Approved

3 2

Epidiolex

Jazz Pharmaceuticals

Phase 3

1 3

N-Acetyl-L-Cysteine

PPeking University People's Hospital

Phase 2

1 4

BXCL501

BBioXcel Therapeutics Inc

Phase 2

1 5

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 6

Bupivacaine-Fentanyl

SSamuel Lunenfeld Research Institute, Mount Sinai Hospital

Preclinical

1 7

Dual NRT

MMassachusetts General Hospital

Preclinical

1 8

L-Tyrosine

DDirection Centrale du Service de Santé des Armées

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Not yet recruiting

Recovery

NCT06943404

Q4 2027

Phase 1Recruiting

Schizophrenia

NCT05025605

Clinical

Trials by Indication[1]

Agitation5 trials

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

Terminated·BBioXcel Therapeutics Inc·Phase 3·NCT05665088·13 enrolled

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of BXCL501 For The Treatment of Agitation Associated With Dementia

Terminated·BBioXcel Therapeutics Inc·Phase 2·NCT05276830·5 enrolled

A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Determine Efficacy and Safety of BXCL501 In Agitation Associated With Schizophrenia

Completed·BBioXcel Therapeutics Inc·Phase 3·NCT04268303·380 enrolled

Show 2 more trials

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled, Ascending Starting Dose Finding, Safety, and Efficacy Study of BXCL501 in Agitation Associated With Delirium in ICU Patients.

Withdrawn·BBioXcel Therapeutics Inc·Phase 2·NCT05313386

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy And Safety Study of PRN Dosing of BXCL501 Over A 12 Week Period In Subjects With Agitation Associated With Dementia

Completed·BBioXcel Therapeutics Inc·Phase 3·NCT05271552·151 enrolled

Recovery1 trial

BXCL501 After Stress to Increase Recovery Success

Not yet recruiting·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT06943404·100 enrolled

Opioid Withdrawal1 trial

Sublingual Dexmedetomidine for Treating Opioid Withdrawal

Active, not recruiting·NNew York State Psychiatric Institute·Phase 1/2·NCT05712707·160 enrolled

Schizophrenia1 trial

A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

Recruiting·BBioXcel Therapeutics Inc·Phase 1·NCT05025605·140 enrolled

Agitation,Psychomotor1 trial

Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar Disorder

Completed·BBioXcel Therapeutics Inc·Phase 3·NCT05658510·452 enrolled

1 more indication

Bipolar I Disorder1 trial

Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder

Completed·BBioXcel Therapeutics Inc·Phase 2·NCT07116694·33 enrolled

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for BXCL501. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — BXCL501 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for BXCL501. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — BioXcel Therapeutics Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: BBioXcel Therapeutics Inc

BXCL501

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2027

Trials by Indication[1]

Agitation5 trials

Recovery1 trial

Opioid Withdrawal1 trial

Schizophrenia1 trial

Agitation,Psychomotor1 trial

Bipolar I Disorder1 trial

References

Drug Info

Quick Facts

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