“Tirbanibulin was evaluated in repeat-dose general toxicity studies involving topical administration to the skin of rats and minipigs for up to 4 weeks, as well as in studies that involved oral dosing of rats and dogs for up to 4 weeks.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
Pivotal GLP studies
Topical rat and minipig and oral rat and dog repeat-dose studies, up to 4 weeks
“Tirbanibulin was evaluated in repeat-dose general toxicity studies involving topical administration to the skin of rats and minipigs for up to 4 weeks, as well as in studies that involved oral dosing of rats and dogs for up to 4 weeks.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
Route in tox
Topical (dermal) and oral gavage
“Tirbanibulin has been evaluated in a battery of nonclinical studies that included evaluation of ADME, pharmacology, safety pharmacology, repeat-dose toxicity (via both the oral and topical routes), genetic toxicology, reproductive toxicology, and evaluation for potential to induce ocular irritation or sensitization.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗