Welcome to the new CiPA site!

CIPA Initiative

The objective of the CIPA initiative is to facilitate the adoption of a new paradigm for assessment of clinical potential of TdP that is not measured exclusively by potency of hERG block and not at all by QT prolongation.

FDA Advisory Committee Meeting

The FDA Advisory Committee met recently to discuss CiPA. See more here.

2 New Manuscripts Published

“Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block”  as well as the companion methods paper “Automated Algorithm for J-Tpeak and Tpeak-Tend Assessment of Drug-Induced Proarrhythmia Risk” have been published in PLOS One. Download the PDFs on our Publications page and find the clinical study data and algorithm source code here.

The new CIPA paradigm will be driven by a suite of mechanistically based in vitro assays coupled to in silico reconstructions of cellular cardiac electrophysiologic activity, with verification of completeness through comparison of predicted and observed responses in human-derived cardiac myocytes. To the extent that the ongoing validation program is successful, we envision petitioning for corresponding changes to regulatory requirements for proarrhythmia assessment and these might include eliminating or waiving the need for the TQT.

About

The objective of the CIPA initiative is to facilitate the adoption of a new paradigm for assessment of clinical potential of TdP that is not measured exclusively by potency of hERG block and not at all by QT prolongation.

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Work Streams

The work streams have recently been initiated and are open to interested participants. See below for more information on how to join. 

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CiPA Steering Team

The Steering Team acts as liaisons between the work streams and the organizations and stakeholders and meets to discuss project milestones.

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CiPA Compounds

The final compound list is available here.

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