Two dozen trials in Russia, Ukraine are testing a company’s lead product
Most trials at risk are evaluating products with prior approvals
Russia’s invasion of Ukraine may put recruitment of over 100 industry-sponsored trials of drugs and biologics at risk, but the majority of those trials are testing products that are already approved. BioCentury identified 45 trials of unapproved drugs or biologics potentially at risk, defined as having 25% or more of sites listed in ClinicalTrials.gov in either country. While the war itself is the greatest risk to trials in Ukraine, sites in Russia may be subject to international sanctions or individual companies choosing to disinvest in the country.
Of the 45 trials of potential new products, just over half represent the sponsor’s lead product, while several more are the lead trial of a backup compound or a new product for a company that already has other products on the market. Six of the trials are treating schizophrenia, including three of the five Phase III trials of ulotaront (SEP-363856) from the Sunovion unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506). Four each are focused on ulcerative colitis or treating or preventing COVID-19. ...