Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Biodistribution & persistence
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Modality-specific risk
Abuse potential (CNS stimulant); recommended for Schedule III
“CSS reviewed the nonclinical and clinical abuse-related data submitted in NDA 218145 for centanafadine and concluded that the drug has abuse potential and should be recommended for placement in Schedule III of the CSA, if the NDA for centanafadine is approved as a drug product.”
✓ VerifiedFDA multi-discipline review, p. 223Source ↗