Cypsedo: genotox, carcinogenicity and repro: done or skipped?

“Cipepofol was not genotoxic in a standard battery of genotoxicity assays, testing negative in an in vitro Ames assay, in the in vitro chromosomal aberration assay, and in the in vivo bone marrow micronucleus test in mice.”

“The carcinogenic potential of cipepofol has not been evaluated.”

“It appears that the significantly increased post-implantation loss was mainly driven by increased resorption. Similar, but not significant and not dose-dependent, effects were observed in the FEED study in rats with every other day IV dosing. The reproductive effects observed in the FEED studies are likely related to maternal hypoxia secondary to anesthesia.”

“Temporary cardiovascular (CV) effects during anesthesia, including reduced blood pressure and ECG changes such as an increase in QTcF, were observed in the cardiovascular safety pharmacology study and a single-dose toxicology study in dogs.”

“Cipepofol was not genotoxic in a standard battery of genotoxicity assays, testing negative in an in vitro Ames assay, in the in vitro chromosomal aberration assay, and in the in vivo bone marrow micronucleus test in mice.”

“Cipepofol was not genotoxic in a standard battery of genotoxicity assays, testing negative in an in vitro Ames assay, in the in vitro chromosomal aberration assay, and in the in vivo bone marrow micronucleus test in mice.”

“Cipepofol was not genotoxic in a standard battery of genotoxicity assays, testing negative in an in vitro Ames assay, in the in vitro chromosomal aberration assay, and in the in vivo bone marrow micronucleus test in mice.”

“Carcinogenicity studies are not required to approve a drug product indicated for acute use.”

“Carcinogenicity studies are not required to approve a drug product indicated for acute use.”

“Temporary cardiovascular effects during anesthesia, including reduced blood pressure and electrocardiogram (ECG) changes such as an increase in QTcF interval, were observed in the cardiovascular safety pharmacology study and in a single-dose toxicology study in dogs. QTc prolongation occurred at or below the human exposure at the maximum human induction dose.”