Breakthrough Therapies

The Breakthrough Therapies chart is an interactive database of all publicly announced Breakthrough Therapy Designations (BTDs) since the program’s inception in 2012. As of March 2026, the U.S. Food and Drug Administration (FDA) reported it has received 1622 BTD requests, granted 634 BTDs, and approved 374 Breakthrough Therapy designated products. 

The chart is updated regularly and includes information about each designation including the drug name or investigational code name, the drug sponsor, the date of the designation’s public disclosure, the indication granted BTD, and the current status of the designation.  

Click here to learn more about the history of Breakthrough Therapies.