Overview
Cerlapirdine has been investigated for the treatment of Alzheimer Disease.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Cerlapirdine (SAM-531): A Pharmacological and Clinical Development Review of a Discontinued 5-HT6 Receptor Antagonist
Executive Summary
Cerlapirdine (DrugBank ID: DB12229), also known by its developmental codes SAM-531, PF-05212365, and WAY-262,531, is an investigational small molecule that was developed by Wyeth and later Pfizer for the treatment of cognitive disorders, primarily targeting Alzheimer's disease (AD) and schizophrenia.[1] As a selective and potent antagonist of the serotonin 6 (5-HT6) receptor, Cerlapirdine was designed based on the prevailing therapeutic hypothesis that blocking this central nervous system (CNS)-specific receptor could enhance cholinergic and glutamatergic neurotransmission, thereby producing a pro-cognitive effect.[2] The compound progressed through a comprehensive Phase I program and into Phase II clinical trials to evaluate its efficacy and safety in patients with mild-to-moderate AD.[2]
Despite initial reports suggesting the Phase II trial "demonstrated a trend toward efficacy" and a favorable tolerability profile within the study, the overall data package was evidently insufficient to support advancement into pivotal Phase III studies.[1] Subsequent analysis and strategic company decisions reveal that the drug ultimately "failed to show clinical efficacy at any dose".[7] The development of Cerlapirdine was officially discontinued around 2011, marking the end of its clinical investigation.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2010/12/03 | Phase 1 | Completed | |||
2009/05/21 | Phase 1 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2008/09/03 | Phase 1 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2008/07/31 | Phase 1 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2007/08/22 | Phase 1 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2007/06/01 | Phase 2 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2007/05/31 | Phase 1 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2007/05/28 | Phase 1 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2007/05/28 | Phase 1 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2007/05/28 | Phase 1 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer |
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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