“Repeat-dose toxicology studies were conducted in mice (4-weeks and 13-weeks) and monkeys (4-weeks and 13-weeks).”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
Why that species
Cross-species PK exposure, metabolic profiles, similar or identical CypA binding and identical KRAS GTPase-domain sequence
“Mice and cynomolgus monkeys were considered the relevant test species for in vivo toxicology studies based on cross-species PK exposures, metabolic profiles, similar (mouse) or identical (monkey) binding affinity to human cyclophilin A (CypA), and identical cross-species KRAS protein sequence in the guanosine 5' triphosphatase (GTPase) domain to which daraxonrasib binds.”
✓ VerifiedFDA multi-discipline review, p. 49Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“Daraxonrasib was administered once daily by oral gavage in repeat-dose studies to mice and monkeys in toxicity studies for up to 13-weeks in duration.”
✓ VerifiedFDA multi-discipline review, p. 49Source ↗