Norovirus is an RNA virus of the Caliciviridae family, and a human enteric pathogen that causes inflammation of the intestines and/or stomach, known as acute gastroenteritis. Human noroviruses are the principal cause of pandemic gastroenteritis in people of all age  groups.

Key Takeaways

• Worldwide, about one out of every five cases of acute gastroenteritis is caused by norovirus. Norovirus is responsible for approximately 685 million cases of gastroenteritis every year.
• Globally, norovirus is estimated to cause approximately 200,000 deaths annually, including an estimated 70,000 child deaths, mainly in developing countries.
• The largest proportion of industry-sponsored assets in active clinical development for norovirus are in Phase I. Almost all the clinical products currently in development for norovirus are vaccines, with only one product being a therapeutic agent. These are administered via the oral, intranasal, and percutaneous catheter/injection routes.
• The overall likelihood of approval of a Phase I antiviral asset is 13%, and the average probability an asset advances from Phase III is 67.7%. Assets, on average, take 8.5 years from Phase I to approval, compared to 9.0 years in the overall infectious disease space.
• The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for norovirus have been in the early and mid-phases of development, with 91% of trials in Phase I–II, and only 9% in Phase III–IV.
• The US has a substantial lead in the number of norovirus clinical trials globally. Takeda has the highest number of completed clinical trials for norovirus, with 12 trials. Takeda also leads industry sponsors with the highest overall number of clinical trials for norovirus.