Fully enrolled and not recruiting for Phase 2 Study
The Phase 2 study evaluating the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of SPG601 in adult men with Fragile X syndrome is now completed.
The FDA has approved the U.S. IND (IND 169282) and granted both Orphan Drug and Fast Track designations to SPG601 for the treatment of FXS.