FDA Report-Title Analysis Finds More In Vitro NAMs, Mostly in IND Submissions
A study of 574,963 nonclinical report titles identified 1,381 in vitro NAM-related reports across 981 applications. Stem-cell-derived models, co-cultures and sandwich cultures accounted for most of the identified studies.
Searching Fifteen Years of Submitted Reports
FDA researchers examined titles of nonclinical study reports submitted to the Center for Drug Evaluation and Research from 2011 through 2025. They used keyword searches followed by manual curation and classified the identified reports by platform and study purpose.
Among 574,963 reports, they identified 1,381 related to in vitro NAMs, representing 0.24% of the report total and covering 981 applications. Annual numbers rose overall from 42 reports in 2014 to 186 in 2025; the corresponding shares were 0.14% and 0.40%.
The Platforms and Applications Most Often Identified
Investigational New Drug applications accounted for 87.6% of the identified reports, New Drug Applications for 10.9%, and Biologics License Applications for 1.5%. Stem-cell-derived models, co-cultures and sandwich cultures were most frequent, while 3D tissue models and microphysiological or organ-on-chip systems appeared less often.
Sandwich cultures predominated in pharmacokinetic applications. Stem-cell-derived and co-culture systems often appeared in pharmacology studies, and toxicology reports used the broadest platform mix. The study tracks identifiable in vitro NAMs through submitted report titles, with platform use varying across these nonclinical purposes.