Highest tissue levels in kidney cortex, clitoris, uveal tract/retina, adrenal gland and liver
“The highest levels of fezolinetant in tissues were associated with the kidney cortex, clitoris, uveal tract/retina, adrenal gland (cortex and medulla) and liver.”
✓ VerifiedFDA pharmacology/toxicology review, p. 19Source ↗
Modality-specific risk
Malignancy and tumor-promoter potential (assessed; no mechanism identified)
“Based on the currently available nonclinical information provided by the Applicant and in the published literature, no biological mechanism was identified that indicated an increased risk of malignancy or tumor promotor activity with fezolinetant or through”
✓ VerifiedFDA pharmacology/toxicology review, p. 9Source ↗
Anti-drug antibodies: animals
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.
Anti-drug antibodies: patients
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.