In 2025, there were **Â drugs in total that received a breakthrough designation by the FDA. The FDA recommends that submissions for breakthrough therapy designations should be made prior to phase III.
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Food and Drug Administration. (January 24, 2026). Number of FDA breakthrough drugs designations by therapy area in 2025 [Graph]. In ÌÇÐÄÆƽâ°æ. Retrieved July 23, 2026, from /statistics/695911/fda-breakthrough-therapy-designations-in-the-us-by-therapy-area/
Food and Drug Administration. "Number of FDA breakthrough drugs designations by therapy area in 2025." Chart. January 24, 2026. ÌÇÐÄÆƽâ°æ. Accessed July 23, 2026. /statistics/695911/fda-breakthrough-therapy-designations-in-the-us-by-therapy-area/
Food and Drug Administration. (2026). Number of FDA breakthrough drugs designations by therapy area in 2025. ÌÇÐÄÆƽâ°æ. ÌÇÐÄÆƽâ°æ Inc.. Accessed: July 23, 2026. /statistics/695911/fda-breakthrough-therapy-designations-in-the-us-by-therapy-area/
Food and Drug Administration. "Number of Fda Breakthrough Drugs Designations by Therapy Area in 2025." ÌÇÐÄÆƽâ°æ, ÌÇÐÄÆƽâ°æ Inc., 24 Jan 2026, /statistics/695911/fda-breakthrough-therapy-designations-in-the-us-by-therapy-area/
Food and Drug Administration, Number of FDA breakthrough drugs designations by therapy area in 2025 ÌÇÐÄÆƽâ°æ, /statistics/695911/fda-breakthrough-therapy-designations-in-the-us-by-therapy-area/ (last visited July 23, 2026)
Number of FDA breakthrough drugs designations by therapy area in 2025 [Graph], Food and Drug Administration, January 24, 2026. [Online]. Available: /statistics/695911/fda-breakthrough-therapy-designations-in-the-us-by-therapy-area/
