A study of success rates of clinical drug development analyzed phase transitions in BioMedTracker from 2003 through 2011, including primary and secondary indications. The data set comprised 4,451 drugs from 835 firms. The “likelihood of approval” (LOA) (the probability of a drug reaching FDA approval from its current phase) was 10.4% for phase 1 to phase 2, 16.2% for phase 2 to phase 3, 50.0% for phase 3 to new drug application (NDA)/biologic license application (BLA), and 83.2% for NDA/BLA to approval. The “phase success” (the probability that a drug advanced to the next phase) was 64.5% for phase 1 to phase 2, 32.4% for phase 2 to phase 3, 60.1% for phase 3 to NDA/BLA, and 83.2% for NDA/BLA to approval. Biologics had higher LOAs and “phase successes” than new molecular entities for all transitions. Oncology drugs had the lowest LOA from phase 1 at 6.7%. “Other drugs” (for allergy, gastroenterology, dermatology and other conditions) had the highest, at 18.2%. Infectious disease and autoimmune-immunology drugs had LOAs from phase 1 of 16.7% and 12.7%, respectively.

Source: Nature Biotechnology