Generalized lymphoid depletion contributed to deaths in 2-week rat studies at ≥200 mg/kg/day
“In the 2-week studies, mortality was noted following repeated doses ≥ 200 mg/kg/day in rats and doses ≥ 200/80 mg/kg/day in monkeys. In rats, the deaths were attributed to inappetence and generalized lymphoid depletion.”
✓ VerifiedFDA multi-discipline review, p. 51Source ↗
Biodistribution & persistence
Crosses the blood-brain barrier in mice and rats
“Relacorilant crossed the blood-brain barrier in both mice and rats (Studies S-COR-101 and S-COR-065).”
✓ VerifiedFDA multi-discipline review, p. 46Source ↗
Modality-specific risk
GR modulation and compensatory HPA-axis perturbation
“Furthermore, relacorilant produced primarily effects related to GR modulation and/or compensatory perturbations of the hypothalamic-pituitary-adrenal axis.”
✓ VerifiedFDA multi-discipline review, p. 51Source ↗