Dr. Lee

Newron Pharmaceutical announces progress with sarizotan

May 18, 2016

Newron Pharmaceutical just announced that their Investigational New Drug (IND) application for sarizotan has been approved.  Sarizotan is a novel compound for Rett syndrome, which had already been granted an Orphan Drug Designation.  Sarizotan has shown to reduce the number of episodes of apnea in mice models of Rett syndrome. With this approval, Newron expects to start a clinical STARS (Sarizotan Treatment of Apneas in Rett Syndrome) trial in the third quarter of 2016.  The STARS trial will first be conducted in the U.S. Newron said that it is in ‘extensive discussions’ with regulatory authorities.

This is extremely exciting news for Rett syndrome and Rettsyndrome.org.  Sarizotan is one compound that was studied through our IRSF research grants and has now moved much farther down the drug pipeline.  With FDA approval of the IND, it can now go into clinical development for treatment of breathing difficulties associated with Rett syndrome.  We are hopeful that sarizotan will be successful in these clinical trials to become an approved therapy for treatment of Rett syndrome.

Read the full press release.