Posted by Michael Wonder on 19 Dec 2025
Egetis Therapeutics initiates new drug application in the USA for Emcitate (tiratricol) for MCT8 deficiency
19 December 2025 - Egetis Therapeutics today announced that the Company has initiated a rolling new drug application submission to the US FDA for Emcitate (tiratricol), its investigational drug for the treatment of MCT8 deficiency.
Emcitate (tiratricol) was awarded breakthrough therapy designation by the FDA in July 2025 and in October 2025 the FDA granted a rolling new drug application submission and review based on currently available data.
