IRLAB's mesdopetam IND accepted by the US FDA
IRLAB (Nasdaq Stockholm: IRLAB A) announced today that the U.S. Food and Drug Administration (FDA) has accepted IRLAB's investigational new drug application (IND) for the drug candidate mesdopetam (IRL790). The acceptance of the IND will allow IRLAB to include US patients in the upcoming clinical trial in Parkinson's disease in accordance with the study protocol submitted with the IND application. The planned Phase IIb/III study for mesdopetam will thus include hospitals and enrol patients in the US and Europe. Mesdopetam is in development for the treatment of levodopa-induced dyskinesias in