Further trials3 Sep 2020 09:52
I've been researching the liver toxicity concerns and it looks as though dihydrofolate reductase inhibitors (e.g. Iclaprim) inhibit the production of chemicals in the body that reduce folate.
This is a concern because it causes folate to build up in the liver, and since it isn't known for sure that this buildup doesn't cause damage it can't be ruled out without further data.
So as far as I can tell, there's no data suggesting Iclaprim is harmful to the liver. But it needs to be proven it isn't.
What I'm hoping is that someone with knowledge of clinical trials can tell me, in order to get FDA approval would it be enough to just dose volunteers with Iclaprim and monitor their liver functions, or would they need to entirely repeat the Phase 3 trials they've already conducted, but with the addition of monitoring liver function?