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Bifeprunox

Phase 3

Bipolar Disorder | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Feb 15, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment434

FDA Designations

No designations recorded

Clinical trial landscape

Bifeprunox · 3 trials · 3 indications

Phase 3 2Phase 1 1
NCT00134459Study Evaluating Bifeprunox in Bipolar DepressionBipolar Disorder
COMPLETED434 Analytics
NCT00245973Study Evaluating Bifeprunox in Bipolar DepressionDepression Bipolar
COMPLETED380 Analytics
PHASE3COMPLETED
Study Evaluating Bifeprunox in Bipolar Depression
Bipolar Disorder
NCT00134459434
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PHASE3COMPLETED
Study Evaluating Bifeprunox in Bipolar Depression
Depression Bipolar
NCT00245973380
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Study Endpoints

Primary Endpoints

The objective of this study is to investigate if 8 weeks of treatment with flexible doses of bifeprunox (20 to 40 mg/day) is superior to treatment with placebo in depressed outpatients with bipolar disorder.
Secondary measurement scales will be used:
Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
Tolerability
28 days

Secondary Endpoints

Using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS), total score as the primary efficacy endpoint
Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALbifeprunox 25 day
BEXPERIMENTALbifeprunox 14 day
CEXPERIMENTALbifeprunox 14 day
DEXPERIMENTALbifeprunox 9 day

Interventions

NameTypeDescription
BifeprunoxDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Diagnosis of bipolar disorder * Experiencing a depressive episode

Countries:United States
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Competitive Landscape -Bipolar Disorder 20 trials

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY4PHASE3KarXT
AbbVie, Inc.ABBV3PHASE3Cariprazine
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
Xenon Pharmaceuticals Inc.XENE2PHASE3Azetukalner
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Rapport Therapeutics, Inc.RAPP1PHASE2RAP-219
Neurocrine Biosciences, Inc.NBIX1PHASE2NBI-1117568
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-100
LB Pharmaceuticals, Inc.LBRX1PHASE2LB-102
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Alzamend Neuro, Inc.ALZN1PHASE1AL001, Lithium carbonate
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Frequently asked questions about Bifeprunox

What is Bifeprunox used for?

Bifeprunox is an investigational small molecule being studied for psychiatric conditions, including bipolar depression, schizophrenia, and bipolar disorder. It has been evaluated in clinical trials for these indications, though it is not approved and remains in clinical development.

Who is developing Bifeprunox?

Bifeprunox is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug has been studied in Phase 3 clinical trials for psychiatric indications.

What phase is Bifeprunox in?

Bifeprunox has been studied in Phase 3 clinical trials for bipolar depression and schizophrenia, as well as in a Phase 1 trial in healthy subjects. It is an investigational drug and is not approved for any use.

What clinical trials is Bifeprunox in?

Bifeprunox has been evaluated in several completed trials, including NCT00245973 for bipolar depression, NCT00366171 and NCT00380224 for schizophrenia, and NCT00581451 in healthy subjects. These trials were conducted in the United States and enrolled adults aged 18 years and older.

Is Bifeprunox the same as any other drug?

Bifeprunox is a distinct investigational compound developed by Pfizer. No alternative names for Bifeprunox have been reported in the clinical trial records.