And a placebo beat it in phase 3 trials lol.
The subject line of this thread reads like it was created with an online jargon generator.
Ulotaront failed in phase 3 for schizophrenia. But it doesn’t mean the FDA has forgotten. Now they are testing it for other diseases.
It’s still in trial for schizophrenia, ulotaront has insomnia and headache as side effects I think that’s a lot better than dry mouth and weight gain.
Maybe it’ll get approved as an add on.
I don’t know if they are going to retry a phase 3 trial. If they do, we will have to wait at least 4 more years to see it on the market.
Maybe when schizophrenia is subdivided into types based on biomarkers, one of the subtypes will respond to ulotaront. Who knows.
They have multiple phase 3 going on, including china and Japan, they still have ongoing trials is what I am saying
Maybe it will end up as a drug that has an effect somewhat similar to lamotrigine, which also dampens down glutamate activity, although through a different route. In that case, it would present an additional option for those seeking to avoid mood swings; maybe as an addon to a ‘classical’ antidepressant.
Having an additional treatment option is better than not having it.
It lowered PANSS in phase 3 but did not statistically separate from placebo that also lowered PANSS.
Do you think there is a chance that Ulotaront could be approved in phase 3 in another attempt? From what I read, they attributed that there was no difference with the placebo due to the effect of the pandemic.
I think it has a good chance of being approved for schizophrenia. However, there was a trial compared with high dose Seroquel that completed quite a while ago and results have not been released. There are phase 3 trials still running.
Thanks for the information!