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pexacerfont

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment260

FDA Designations

No designations recorded

Clinical trial landscape

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 is an investigational small molecule being studied for the treatment of Major Depressive Disorder and Generalized Anxiety Disorder. It is being developed by Bristol-Myers Squibb Company (BMY). As of now, it is in clinical development and has not been approved by the FDA.

What does Pexacerfont target?

The specific molecular target of Pexacerfont is not disclosed in available information. It is being studied for its potential effects in psychiatric conditions such as Major Depressive Disorder and Generalized Anxiety Disorder, but its mechanism of action has not been publicly detailed.

Who makes Pexacerfont?

Pexacerfont is being developed by Bristol-Myers Squibb Company, a pharmaceutical company listed on the stock exchange under the ticker symbol BMY. The company has conducted clinical trials to evaluate the drug's safety and efficacy in psychiatric indications.

What phase is Pexacerfont in?

Pexacerfont has completed a Phase 1 trial for Major Depressive Disorder and a Phase 2 trial for Generalized Anxiety Disorder. Both trials are completed, and the drug is not yet approved. It remains an investigational compound in clinical development.

What clinical trials is Pexacerfont in?

Pexacerfont has been studied in two completed clinical trials. NCT00135421 was a Phase 1 study in 271 female outpatients with Major Depressive Disorder in the United States. NCT00481325 was a Phase 2 study in 260 female outpatients with Generalized Anxiety Disorder, also in the United States.

Is Pexacerfont the same as BMS-562086?

Yes, Pexacerfont is also known as BMS-562086. The clinical trial NCT00135421 refers to the drug as BMS-562086 in its title, confirming that these names refer to the same investigational compound.