Case Study

Evaluating Hepatoxicity Before Late-Stage Trials: How Biohaven Used QST to Ensure Liver Safety and Gain Regulatory Approval


Biohaven Pharmaceuticals developed two second-generation calcitonin gene-related peptide (CGRP) receptor antagonists—rimegepant and zavegepant —for use in treating migraines.

1 Billion
migraine sufferers worldwide
2 FDA-approved
drugs on the market

“Migraine affects more than one billion individuals each year across the world, and is one of the most common neurologic disorders, with a high prevalence and morbidity, especially among young adults and females.”

National Library of Medicine, National Institutes of Health

A large pharma company had originally developed a first-generation CGRP receptor antagonist, telcagepant, for migraine treatment. It failed in clinical trials due to hepatoxicity.

After telcagepant’s failure, Biohaven had two next-generation CGRP receptor antagonists in development and advancing into clinical trials. Before proceeding further, they required more confidence in the liver safety of these compounds.