Bifeprunox

Overview

Bifeprunox is a novel atypical antipsychotic agent which, along with SLV313, aripiprazole and SSR-181507 combines minimal D2 receptor agonism with 5-HT receptor agonism.

Indication

Bifeprunox is being evaluated for the treatment of schizophrenia, psychosis, and Parkinson's disease.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Bifeprunox Extension to Extension Study in Patients With Schizophrenia	2009/03/13	NCT00861497	Phase 3	Terminated	H. Lundbeck A/S
Efficacy of Bifeprunox in Patients With Schizophrenia	2008/06/25	NCT00704509	Phase 3	Terminated	H. Lundbeck A/S
Efficacy of Bifeprunox in Patients With Schizophrenia	2008/04/15	NCT00658645	Phase 3	Terminated	H. Lundbeck A/S
Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects	2007/12/27	NCT00581451	Phase 1	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients	2006/11/06	NCT00396214	Phase 3	Terminated	Solvay Pharmaceuticals
Open Label Extension Study of Bifeprunox	2006/08/21	NCT00366171	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Study Evaluating Bifeprunox in Patients With Schizophrenia.	2006/08/21	NCT00366327	Phase 3	Terminated	Wyeth is now a wholly owned subsidiary of Pfizer
Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint	2006/08/21	NCT00366704	Phase 3	Terminated	Wyeth is now a wholly owned subsidiary of Pfizer
Study Evaluating Bifeprunox in Bipolar Depression	2005/10/28	NCT00245973	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Patient-reported Outcomes in the Treatment of Schizophrenia	2005/10/03	NCT00230828	Phase 3	Completed	Solvay Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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