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bifeprunox

Phase 3

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

bifeprunox development status

Highest phase Phase 3
Registered trials 7 across 1 sponsor since Aug 2005

bifeprunox target and mechanism

Molecular targetHTR1A, DRD2
Target classPartial Agonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment1,054

FDA Designations

No designations recorded

bifeprunox clinical trials

bifeprunox · 4 trials · 3 indications

Phase 3 4
NCT00366171Open Label Extension Study of BifeprunoxSchizophrenia
COMPLETED120 Analytics
NCT00380224Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.Schizophrenia
COMPLETED120 Analytics
NCT00134459Study Evaluating Bifeprunox in Bipolar DepressionBipolar Disorder
COMPLETED434 Analytics
NCT00245973Study Evaluating Bifeprunox in Bipolar DepressionDepression Bipolar
COMPLETED380 Analytics
PHASE3COMPLETED
Open Label Extension Study of Bifeprunox
SchizophreniaUnlock trial analytics
PHASE3COMPLETED
Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.
SchizophreniaUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Bifeprunox in Bipolar Depression
Bipolar DisorderUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Bifeprunox in Bipolar Depression
Depression BipolarUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in body weight from baseline/first dose of bifeprunox at each observation.
Change from baseline on body weight at the final evaluation.
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

Secondary Endpoints

Change from baseline/first dose of bifeprunox for triglyceride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression (CGI)-Score, and waist circumference at each observation.
Change from baseline in triglyceride level; Change from baseline in waist circumference; and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.
Using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS), total score as the primary efficacy endpoint
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
BifeprunoxDRUG -
bifeprunox, olanzapineDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 66 Years
SexALL
Healthy VolunteersNo
Study Sites83

Inclusion Criteria: 1. Outpatients who have successfully completed Wyeth study 3168A1-311-US. 2. A signed and dated informed consent form for this study. 3. No major protocol violations in previous study. Exclusion Criteria: 1. Clinically important abnormalities noted in preceding short-term stud...

Countries:United States
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Frequently asked questions about bifeprunox

What is bifeprunox used for?

Bifeprunox was developed for the treatment of schizophrenia, bipolar disorder, and bipolar depression. It is a small molecule psychiatric drug that reached Phase 3 clinical testing. All of its recorded trials are completed, and it is not currently listed as an approved medicine.

What does bifeprunox target?

Bifeprunox targets the serotonin 5-HT1A receptor (HTR1A) and the dopamine D2 receptor (DRD2). It acts as a partial agonist at these receptors, meaning it produces a moderated rather than full activation signal. This dual receptor activity is the basis for its proposed antipsychotic and mood-stabilizing effects.

Who makes bifeprunox?

Bifeprunox was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 3 clinical program evaluating the compound in schizophrenia and bipolar depression.

What phase is bifeprunox in?

Bifeprunox reached Phase 3 clinical development. It is an investigational drug and is not approved for marketing. Its registered trials are all listed as completed, and no trials are currently active.

What clinical trials is bifeprunox in?

Bifeprunox was studied in completed Phase 3 trials including NCT00380224, which compared bifeprunox with olanzapine on weight in outpatients with schizophrenia, NCT00366171, an open label extension study, and NCT00245973 and NCT00134459, both evaluating bifeprunox in bipolar depression.

Is bifeprunox the same as olanzapine?

No. Bifeprunox and olanzapine are different drugs. Bifeprunox was developed by Pfizer as a partial agonist at HTR1A and DRD2. Olanzapine appears in the bifeprunox program as an active comparator in a Phase 3 schizophrenia trial, NCT00380224, which assessed weight effects during treatment.