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Pexacerfont

Phase 2

Generalized Anxiety Disorder | Small molecule | Psychiatry |Bristol-Myers Squibb Company|Trials Updated: Oct 12, 2015

Pexacerfont development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Aug 2005

Pexacerfont target and mechanism

Molecular targetCRHR1
Target classAntagonist
ModalitySmall molecule

Also known as (BMS-562086)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment531

FDA Designations

No designations recorded

Pexacerfont clinical trials

Pexacerfont · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00481325Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety DisorderGeneralized Anxiety Disorder
COMPLETED260 Analytics
PHASE2COMPLETED
Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
Generalized Anxiety DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
Week 8
Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)
Week 8

Secondary Endpoints

Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score
Week 8
Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score
Week 8
Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests
every visit and endpoint
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A1EXPERIMENTAL -
A2ACTIVE_COMPARATOR -
A3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
pexacerfontDRUGTablets \& Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
escitalopramDRUGTablets \& Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
placeboDRUGTablets \& Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
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Eligibility Criteria

Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * Outpatient women ages 18-65 meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for Generalized Anxiety Disorder (GAD), either moderate or severe (300.02) Exclusion Criteria: * Males * Patients who report a...

Countries:United States
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Frequently asked questions about Pexacerfont

What is Pexacerfont used for?

Pexacerfont was studied for the treatment of generalized anxiety disorder and major depressive disorder. It is a small molecule developed by Bristol-Myers Squibb and reached Phase 2 clinical development. It is investigational and has not been approved for any indication.

What does Pexacerfont target?

Pexacerfont targets CRHR1, the corticotropin-releasing hormone receptor 1. It acts as an antagonist at this receptor. This target is associated with the stress response and has been explored in psychiatric conditions such as generalized anxiety disorder and major depressive disorder.

Who is developing Pexacerfont?

Pexacerfont is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company sponsored the clinical trials of the drug in generalized anxiety disorder and major depressive disorder.

What phase is Pexacerfont in?

Pexacerfont is in Phase 2 development. It has completed a Phase 2 trial in generalized anxiety disorder and a Phase 1 trial in major depressive disorder. It is investigational and has not been approved by the FDA for any indication.

What clinical trials is Pexacerfont in?

Pexacerfont has been studied in two completed trials: NCT00481325, a Phase 2 trial in outpatients with generalized anxiety disorder, and NCT00135421, a Phase 1 trial in outpatients with major depressive disorder. Both were conducted in the United States and enrolled adult women.

Is Pexacerfont the same as BMS-562086?

Yes, Pexacerfont is also known as BMS-562086. Both names refer to the same investigational small molecule developed by Bristol-Myers Squibb for generalized anxiety disorder and major depressive disorder.