CIPA Initiative

The CiPA initiative began following a workshop in July 2013 at the US FDA. The objective of the CiPA initiative was to engineer an assay for assessment of the proarrhythmic potential of new drugs with improved specificity compared with the hERG assay plus Thorough QT study.

A CiPA Steering Team comprised of international regulators, industry, academics and nonprofits oversaw the four main work streams:

  1. Ion Channel
  2. In Silico
  3. Stem Cell Derived Myocytes
  4. Clinical ECG

All work streams concluded novel data generation efforts and have published their work (see more here.)

This work was used to inform the ICH E14/S7B Implementation Working Group (IWG.)  This IWG completed a new Q&A document in February 2022. Additionally, they release training materials, available here: https://www.ich.org/page/safety-guidelines. HESI and SPS also hosted a training related to these, which is available on demand here.

The ICH IWG plans to implement a second stage of the revised Q&As to “Create Q&A(s) for S7B and E14 on how to use the proarrythmia prediction algorithms or model results” (see Concept Paper.)

Any ongoing work related to these topics will be posted to this website as it becomes available. Publications and data resources will also be posted. If you are looking for any prior CiPA Materials, please check the archive.

CiPA Steering Team

The CiPA Steering Team does not offer any formal endorsement or certifications at this time. Read the disclaimer.

CiPA Compounds

The final compound list is available here.