Genentech's mycophenolate pregnancy registry listed as completed, last updated October 2026
The FDA-mandated observational registry tracking mycophenolate exposure during pregnancy carries a completed status with its last update posted October 13, 2026.
This week's filing covers one observational registry tied to mycophenolate's FDA-required safety program.
- "The Mycophenolate Pregnancy Registry" (NCT01733082), led by Genentech, Inc. with numerous generic-drug manufacturers listed as collaborators, is a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure.1 The study is listed as completed, with enrollment of 400 participants (actual).1 It serves as a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.1
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