Lymphoid depletion with reduced WBC and lymphocytes in all species, attributed to pharmacology
“Lymphoid tissues (depletion) were target organs in all species and was accompanied by decreased circulating levels of WBC and lymphocytes; this effect of siponimod was attributed to the pharmacological action of the drug.”
✓ VerifiedFDA pharmacology/toxicology review, p. 14Source ↗
Biodistribution & persistence
CNS penetration in rats: brain and spinal cord exposure 0.8- to 4.4-fold blood
“In rats, siponimod was detected in brain and CSF after oral administration. Siponimod exposures in brain and spinal cord were between 0.8- and 4.4-fold that in blood.”
✓ VerifiedFDA pharmacology/toxicology review, p. 26Source ↗
“Safety margins to toxicities observed with administration of siponimod are adequate (lung), can be monitored (cardiovascular), or are described in the labeling (reproductive and development, and carcinogenicity).”
✓ VerifiedFDA pharmacology/toxicology review, p. 15Source ↗