“The GLP-compliant repeat-dose toxicology studies of up to 13 weeks of dosing were conducted in mice and dogs with animals dosed daily via oral gavage.”
✓ VerifiedFDA multi-discipline review, p. 26Source ↗
Why that species
Pharmacologically relevant: high BCL2 sequence homology, comparable in vitro metabolism, adequate bioavailability
“Mice and dogs were pharmacologically relevant species for toxicity evaluation, based on their high BCL2 sequence homology with humans, comparable metabolism profiles with humans in in vitro studies, and adequate bioavailability.”
✓ VerifiedFDA multi-discipline review, p. 35Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“In the 13-week dog study, sonrotoclax was administered at doses of 10, 30, or 100 mg/kg/day.”
✓ VerifiedFDA multi-discipline review, p. 27Source ↗