Following IND approval by the US FDA in Mid-June, 2021, Taivex submitted the Phase I clinical trial application to the Taiwan FDA later on June 28 and received approval on August 20. The anticipated initiation of the Phase I trial remains by end of 2021.
T-1301 Phase I trial is a multi-centered study in Taiwan. The oral solid dosage form is anticipated to enhance patients’ adherence to dosing when joining this trial.