IRLAB's mesdopetam IND accepted by the US FDA
STOCKHOLM, Oct. 1, 2020 /PRNewswire/ -- 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).
- STOCKHOLM, Oct. 1, 2020 /PRNewswire/ -- 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 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 Parkinson's disease, PD-LIDs, with the objective to increase daily good ON-time.
- The FDA clearance of the IND is a quality stamp on the mesdopetam project and validates mesdopetam as a safe and tolerable drug candidate.