Lymphoid depletion with decreased thymus weights in rats at 10 and 40 mg/kg/day subcutaneously
“Additionally, lymphoid depletion was seen in males and females at doses of 10 or 40 mg/kg/day and correlated with thymus weight decreases.”
✓ VerifiedFDA multi-discipline review, p. 41Source ↗
Biodistribution & persistence
Rapid, wide tissue distribution in pigmented rat QWBA, all tissues quantifiable by 1 hour
“In male pigmented rats following a single SC administration of [14C]-tapinarof at 2 mg/kg, radioactivity was rapidly and widely distributed throughout the body with all tissues containing quantifiable radioactivity concentrations by 1-hour post-dose.”
✓ VerifiedFDA multi-discipline review, p. 35Source ↗
Modality-specific risk
Juvenile toxicity: renal pelvic dilatation and thymic changes in juvenile rats
“At ≥ 10/15 mg/kg/day, there were adverse microscopic changes in the form of renal pelvic dilatation in both sexes; test article-related changes also included decreased thymus weight, and decreased cellularity in the thymus and changes of thymic T cell maturation populations.”
✓ VerifiedFDA multi-discipline review, p. 52Source ↗