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# Drug Trial Demographic Info Reported
- URL: https://www.fdaweb.com/drug-trial-demographic-info-reported/
- Published: 2026-06-24T12:00:00.000Z
- Updated: 2026-09-14T13:41:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161368

FDA has published the CDER 2025 *Drug Trials Snapshot Summary Report* with summarized baseline demographic information from pivotal trials that supported the approval of 46 novel drugs in 2025\. The report [says](https://www.fda.gov/media/193285/download?attachment&ref=fdaweb.com) that 20 (43%) of the approved novel drugs were first-in-class, while 23 (50%) were indicated to treat rare or orphan diseases.

The report shows the demographic percentages of sex, race, ethnicity, age group, and U.S. participants in the pivotal trials.

“We hope information from this annual report will help promote further dialog on how drug development can be enhanced to improve knowledge about the safety and effectiveness of therapies to representative patient communities in the U.S.,” the report says.