“OPA-15406 ointments did not show skin sensitization potential in guinea pigs under the study conditions.”
✓ VerifiedFDA multi-discipline review, p. 61Source ↗
Biodistribution & persistence
Crosses the placenta in rats (fetal tissue levels above maternal blood)
“Tissue concentrations of radioactivity in the fetus and in fetal blood, liver, kidney, and lung were higher than maternal blood, indicating 14C-OPA-15406-dependent radioactivity crosses the placental barrier.”
✓ VerifiedFDA multi-discipline review, p. 45Source ↗
Modality-specific risk
Major human metabolites (MIST): three major metabolites covered by pivotal toxicology studies
“There are three major human metabolites: MAP-15484, MAP-15485 and MAP-15497. Overall, these three major metabolites were well covered with the pivotal nonclinical toxicology studies.”
✓ VerifiedFDA multi-discipline review, p. 64Source ↗