“A series of general toxicology studies were completed with relacorilant, including a 28-day study in mice (Table 51), 2-week (Table 52) and 13-week GLP studies in rats (Table 6) and monkeys (Table 7, Table 53), a 26-week GLP study in rats (Table 8), and a 39-week GLP study in monkeys (Table 9).”
✓ VerifiedFDA multi-discipline review, p. 51Source ↗
Pivotal GLP studies
13- and 26-week rat and 13- and 39-week monkey GLP studies
“A series of general toxicology studies were completed with relacorilant, including a 28-day study in mice (Table 51), 2-week (Table 52) and 13-week GLP studies in rats (Table 6) and monkeys (Table 7, Table 53), a 26-week GLP study in rats (Table 8), and a 39-week GLP study in monkeys (Table 9).”
✓ VerifiedFDA multi-discipline review, p. 51Source ↗
Route in tox
Oral (gavage)
“Once daily oral gavage administration of relacorilant to cynomolgus monkeys was well tolerated for 39 weeks at dose levels of 0, 3, 10, and 30 mg/kg/day.”
✓ VerifiedFDA multi-discipline review, p. 59Source ↗